Bronchitol: Uses, Dosage & Side Effects
An inhaled osmotic mucolytic agent used as add-on maintenance therapy to improve lung function in adults with cystic fibrosis
Bronchitol (mannitol) is an inhaled dry powder mucolytic agent approved for the treatment of cystic fibrosis in adults aged 18 years and older. It works as an osmotic agent, drawing water into the airways to rehydrate the thick, sticky mucus that is characteristic of cystic fibrosis. By restoring airway surface liquid and improving mucociliary clearance, Bronchitol helps patients to clear mucus more effectively, leading to measurable improvements in lung function. It is used as an add-on maintenance therapy alongside standard cystic fibrosis care, administered via a dedicated inhaler device using hard capsules containing 40 mg of mannitol.
Quick Facts: Bronchitol
Key Takeaways
- Bronchitol (mannitol) is an inhaled osmotic mucolytic that hydrates airway mucus in cystic fibrosis, improving mucociliary clearance and lung function when used as add-on maintenance therapy.
- A mandatory initiation dose assessment (tolerance test) must be passed before starting treatment; patients who experience significant bronchospasm during the assessment should not use Bronchitol.
- The maintenance dose is 400 mg (10 capsules) inhaled twice daily using the provided inhaler device, with a bronchodilator taken 5–15 minutes before each dose to minimize airway irritation.
- The most common side effects are cough and hemoptysis (coughing up blood), which are related to the drug’s mucolytic action and the underlying condition; bronchospasm is an important adverse effect to monitor.
- Bronchitol can be used alongside other cystic fibrosis therapies including dornase alfa, inhaled antibiotics, and CFTR modulators as part of a comprehensive treatment regimen.
What Is Bronchitol and What Is It Used For?
Bronchitol contains the active substance mannitol, a naturally occurring sugar alcohol (polyol) that has been developed as an inhaled osmotic agent specifically for the management of cystic fibrosis. Mannitol has been used in medicine for decades in other forms – as an intravenous osmotic diuretic to reduce intracranial pressure and as a diagnostic agent for bronchial hyperresponsiveness testing – but its development as an inhaled mucolytic represents an innovative approach to addressing the fundamental airway hydration deficiency that characterizes cystic fibrosis lung disease.
Cystic fibrosis is an inherited genetic disorder caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The CFTR protein functions as a chloride and bicarbonate channel on the surface of epithelial cells, playing a critical role in regulating the volume and composition of fluid on the airway surface. When CFTR is absent or dysfunctional, chloride transport is impaired, leading to dehydration of the airway surface liquid (ASL) and the periciliary layer (PCL) that normally bathes the cilia on the airway epithelium. The result is thick, dehydrated, viscous mucus that is extremely difficult for the cilia to propel upward and out of the lungs. This mucus stasis creates a vicious cycle: retained secretions obstruct airways, foster chronic bacterial infections (particularly with Pseudomonas aeruginosa and Staphylococcus aureus), trigger persistent inflammation, and ultimately cause progressive, irreversible lung damage (bronchiectasis) that is the leading cause of morbidity and mortality in cystic fibrosis.
Bronchitol addresses this pathophysiology through its osmotic properties. When inhaled as a dry powder, mannitol particles are deposited on the airway surface where they create a strong osmotic gradient. Because mannitol is poorly absorbed by the airway epithelium, it draws water from the submucosal tissue and vasculature into the airway lumen through osmosis. This influx of water rehydrates the depleted periciliary layer and the overlying mucus blanket. The restored hydration has two key effects: it reduces mucus viscosity (making it thinner and less sticky) and it increases the depth of the periciliary layer, allowing the cilia to beat more effectively. The net result is improved mucociliary clearance – the lungs’ natural mechanism for removing mucus and trapped particles. Mannitol may also stimulate cough, which further aids in mucus clearance.
In clinical trials, Bronchitol demonstrated statistically significant improvements in lung function as measured by forced expiratory volume in one second (FEV1). The pivotal Phase III trials (DPM-CF-301 and DPM-CF-302) enrolled adult patients with cystic fibrosis and showed that inhaled mannitol 400 mg twice daily, added to standard best care, produced clinically meaningful improvements in FEV1 compared with a non-therapeutic low-dose control. The treatment effect was observed in patients both with and without concomitant use of dornase alfa (recombinant human DNase, another widely used mucolytic in cystic fibrosis). Additional endpoints including pulmonary exacerbation rates and patient-reported outcomes also showed favorable trends.
Bronchitol was first approved in Australia in 2011 for patients with cystic fibrosis aged 6 years and older. The European Medicines Agency (EMA) granted marketing authorization in 2012, initially for adults aged 18 years and older as add-on therapy. The U.S. Food and Drug Administration (FDA) approved Bronchitol in 2020 for the management of cystic fibrosis in adults aged 18 years and older to improve pulmonary function, in conjunction with best standard of care. It is important to note that approved age groups and indications may vary by country. The drug is classified under the Anatomical Therapeutic Chemical (ATC) code R05CB16 (mucolytics).
Unlike enzymatic mucolytics such as dornase alfa, which break down extracellular DNA in mucus, Bronchitol works through a physical osmotic mechanism. By drawing water into the airways, it addresses the fundamental hydration deficiency in cystic fibrosis. These two mechanisms are complementary, which is why Bronchitol can be used together with dornase alfa for additive benefit.
What Should You Know Before Taking Bronchitol?
Contraindications
Bronchitol should not be used in certain situations. Understanding these contraindications is essential for patient safety.
- Hypersensitivity: Do not use Bronchitol if you are allergic to mannitol or any of the other ingredients in the product (the capsule shell contains gelatin). Allergic reactions may include rash, swelling, or difficulty breathing.
- Failed initiation dose assessment: Patients who fail the Bronchitol initiation dose assessment (tolerance test) – defined as experiencing a 20% or greater drop in FEV1 from baseline during the test – must not use Bronchitol. This indicates that the patient’s airways are excessively reactive to inhaled mannitol and that treatment would carry an unacceptable risk of severe bronchospasm.
- Unable to perform the initiation dose assessment: Patients who cannot perform spirometry reliably to enable the initiation dose assessment should not start Bronchitol, as the safety of treatment cannot be established without this baseline evaluation.
Warnings and Precautions
Bronchospasm (sudden narrowing of the airways) can occur during and after inhalation of Bronchitol. Always use a short-acting bronchodilator (e.g., salbutamol) 5–15 minutes before each dose. If you experience significant wheezing, breathlessness, or chest tightness after inhalation, stop using Bronchitol and seek medical attention immediately. Have your rescue bronchodilator readily available at all times during treatment.
Before and during treatment with Bronchitol, be aware of the following important precautions:
- Initiation dose assessment: All patients must undergo a supervised initiation dose assessment before starting treatment. This involves inhaling increasing doses of mannitol in a clinical setting while lung function is monitored. The assessment determines whether you can tolerate inhaled mannitol without dangerous bronchospasm. If you pass the assessment, you can begin treatment at full dose.
- Bronchial hyperresponsiveness: Patients with known bronchial hyperresponsiveness may be at increased risk of bronchospasm with inhaled mannitol. While the initiation dose assessment is designed to identify these patients, ongoing monitoring is important. If your underlying respiratory condition changes significantly, your doctor may reassess your suitability for continued treatment.
- Hemoptysis: Coughing up blood (hemoptysis) is a complication of advanced cystic fibrosis lung disease and has been reported during Bronchitol treatment. If you experience significant or persistent hemoptysis (more than streaks of blood in sputum), discontinue Bronchitol and consult your doctor immediately. Treatment should not be started during active massive hemoptysis. Your doctor will assess whether it is safe to resume treatment after an episode of hemoptysis has resolved.
- Cough: Cough is very common during Bronchitol treatment and is expected as part of the drug’s mucolytic action. The osmotic effect stimulates cough, which aids in clearing mucus. However, persistent, severe, or distressing cough that does not improve with bronchodilator use should be discussed with your healthcare team, as dose adjustments may be considered.
- Conditions aggravated by mannitol or vigorous coughing: Use caution if you have conditions that may be worsened by osmotic stress on the airways or by forceful coughing, such as active significant hemoptysis, pneumothorax (collapsed lung), or recent thoracic surgery. Discuss these conditions with your doctor before starting treatment.
- Concomitant inhaled therapies: If you use multiple inhaled therapies (bronchodilators, dornase alfa, inhaled antibiotics, hypertonic saline), your healthcare team will advise on the appropriate order and timing of each therapy to optimize benefit and minimize interactions. Generally, a short-acting bronchodilator is taken first, followed by Bronchitol, and then other inhaled therapies after an appropriate interval.
Pregnancy and Breastfeeding
There is limited clinical data on the use of Bronchitol during pregnancy. Animal studies with inhaled mannitol have not shown direct harmful effects on the developing fetus or reproductive toxicity; however, as a precaution, it is preferable to avoid the use of Bronchitol during pregnancy unless your doctor considers the benefit of treatment to clearly outweigh any potential risk. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
It is not known whether mannitol is excreted in human breast milk following inhalation. However, given that mannitol is a naturally occurring substance with low systemic absorption after inhalation, the risk to a breastfed infant is considered to be minimal. A decision on whether to continue or discontinue breastfeeding or Bronchitol therapy should be made in consultation with your doctor, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.
There is no evidence that inhaled mannitol affects fertility in humans. Animal reproductive studies have not demonstrated any impairment of fertility at doses relevant to clinical use.
Driving and Operating Machinery
Bronchitol has no known effect on the ability to drive and use machines. However, if you experience dizziness or other side effects that could impair your performance, you should not drive or operate machinery until these symptoms have resolved. In general, the inhaled route of administration results in minimal systemic exposure, and the drug is not expected to affect cognitive or motor function.
How Does Bronchitol Interact with Other Drugs?
Because Bronchitol (mannitol) acts locally in the airways and is minimally absorbed into the bloodstream after inhalation, the risk of systemic drug-drug interactions is very low. No formal interaction studies have been conducted. However, considerations relate primarily to the sequencing and timing of multiple inhaled therapies commonly used in cystic fibrosis management. The following information summarizes what is known about concomitant use with other treatments.
Concomitant Inhaled Therapies
| Concomitant Drug | Interaction / Notes | Clinical Recommendation |
|---|---|---|
| Short-acting bronchodilators (e.g., salbutamol, terbutaline) | Must be taken before Bronchitol to reduce risk of bronchospasm | Inhale 5–15 minutes before each Bronchitol dose |
| Dornase alfa (Pulmozyme) | Complementary mechanisms; no negative interaction observed in clinical trials | Can be used together; maintain separation between inhalations as advised by healthcare team |
| Inhaled antibiotics (e.g., tobramycin, colistin, aztreonam lysine) | No known interaction; Bronchitol may improve antibiotic deposition by clearing mucus first | Administer Bronchitol before inhaled antibiotics for optimal lung deposition |
| Hypertonic saline (3–7%) | Both are osmotic agents; combined use has not been extensively studied | Discuss with your doctor; generally one osmotic agent is chosen over the other |
| CFTR modulators (e.g., elexacaftor/tezacaftor/ivacaftor) | Different mechanisms; no known interaction. CFTR modulators work at the protein level, Bronchitol works at the airway surface | Can be used concomitantly; follow your standard treatment regimen |
| Inhaled corticosteroids | No known interaction | Can be used together; follow standard timing guidelines |
Recommended Order of Inhaled Therapies
For patients with cystic fibrosis who use multiple inhaled therapies, the typical recommended order of administration is as follows. However, always follow the specific instructions provided by your healthcare team, as individual recommendations may vary:
- Short-acting bronchodilator (e.g., salbutamol) – to open the airways
- Mucolytic agent (Bronchitol or dornase alfa) – to thin and mobilize mucus
- Airway clearance techniques (physiotherapy, positive expiratory pressure devices) – to physically clear loosened mucus
- Inhaled antibiotics (e.g., tobramycin) – to treat infection after airways are cleared
- Inhaled corticosteroids (if prescribed) – to control inflammation
This sequence is designed to maximize the effectiveness of each therapy: bronchodilators open the airways for better distribution of subsequent inhaled drugs, mucolytics loosen mucus for more effective clearance, and antibiotics reach cleaner airway surfaces for improved bacterial killing. Oral medications such as CFTR modulators, azithromycin, or pancreatic enzymes can generally be taken at any convenient time and do not interact with inhaled Bronchitol.
Because less than 3% of inhaled mannitol is absorbed into the bloodstream, Bronchitol is not expected to interact with oral medications, intravenous drugs, or other systemically administered treatments. There is no need to adjust the dose of other medications when starting or stopping Bronchitol therapy.
What Is the Correct Dosage of Bronchitol?
Bronchitol is available as an inhalation powder in hard capsules, each containing 40 mg of mannitol. The capsules must not be swallowed – they are designed to be used only with the Bronchitol inhaler device provided in the pack. The inhaler punctures the capsule and the patient inhales the dry powder directly into the lungs. Proper inhaler technique is essential for effective drug delivery, and your healthcare team will instruct you on how to use the device correctly.
Initiation Dose Assessment
Mandatory Tolerance Test Before Starting Treatment
Setting: Must be performed in a clinical setting with access to spirometry and resuscitation equipment, supervised by a physician experienced in the management of cystic fibrosis
Procedure: The patient inhales increasing cumulative doses of mannitol (40 mg, 80 mg, 120 mg, 160 mg, up to 400 mg) with FEV1 measured 60 seconds after each dose step
Pass criteria: Patient tolerates the full 400 mg dose without a ≥20% fall in FEV1 from baseline
Fail criteria: FEV1 falls ≥20% from baseline at any dose step – the patient must not use Bronchitol
Duration: Approximately 30–60 minutes including observation
Adults (18 years and older)
Standard Maintenance Dose
Dose: 400 mg (10 capsules × 40 mg each) inhaled twice daily
Timing: Morning and evening, approximately 12 hours apart
Pre-medication: Inhale a short-acting bronchodilator (e.g., salbutamol 200–400 µg) 5–15 minutes before each Bronchitol dose
Administration: Load one capsule at a time into the inhaler, inhale the contents in 1–2 breaths, then repeat for each of the 10 capsules. The total inhalation time is approximately 5–10 minutes per session.
Duration of treatment: Continuous, long-term maintenance therapy. Treatment should be continued as long as the patient benefits and tolerates the medication.
Children and Adolescents
Pediatric Use
EU (EMA): Bronchitol is not approved for patients under 18 years of age. The safety and efficacy in children and adolescents have not been established in the European Union.
Australia (TGA): Bronchitol is approved for patients aged 6 years and older with the same 400 mg twice daily dose.
USA (FDA): Approved for adults aged 18 years and older.
Always follow the approved indications and age range in your country. Do not use Bronchitol in children unless specifically prescribed by a specialist and approved in your jurisdiction.
Elderly Patients
There is limited clinical experience with Bronchitol in patients aged 65 years and older, as cystic fibrosis is predominantly a disease affecting younger adults. No specific dose adjustment is recommended for elderly patients. The same dosing regimen applies. However, as with all medications, elderly patients should be monitored for any age-related changes in lung function or tolerability. Given the natural decline in respiratory function with age, your doctor may take particular care in assessing the benefit-risk profile.
Missed Dose
If you forget to take a dose of Bronchitol, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not inhale a double dose to make up for a forgotten one. Consistent twice-daily dosing is important for maintaining the therapeutic effect, so try to incorporate Bronchitol into your daily routine at regular times. If you frequently forget doses, discuss strategies with your healthcare team to help with adherence.
Overdose
Due to the nature of the inhaler device (requiring individual capsule loading and inhalation), accidental overdose is unlikely. Mannitol has a wide therapeutic margin. In clinical studies, single doses up to 635 mg were administered during bronchial challenge testing without serious adverse effects beyond expected bronchospasm in susceptible individuals. If an excessively large dose is accidentally inhaled, the most likely effects would be increased cough, potential bronchospasm, sore throat, and possibly gastrointestinal discomfort (nausea, diarrhea) if a significant amount is swallowed. Treatment would be symptomatic and supportive, with bronchodilator administration for bronchospasm. Contact a healthcare professional or poison control center if you are concerned about an overdose.
What Are the Side Effects of Bronchitol?
Like all medicines, Bronchitol can cause side effects, although not everybody gets them. Many of the side effects observed during clinical trials are also commonly associated with cystic fibrosis itself, making it important to distinguish between drug-related effects and manifestations of the underlying disease. The following side effects have been reported during clinical studies and post-marketing experience. They are organized by frequency according to the standard medical convention.
Very Common
- Cough – the most frequently reported side effect, occurring in the majority of patients. Cough is an expected pharmacological response to inhaled mannitol and aids in mucus clearance. It is typically productive (bringing up sputum) and tends to be most pronounced at the start of treatment, often decreasing in intensity over time as the patient adapts.
- Condition aggravation (pulmonary exacerbation) – worsening of cystic fibrosis respiratory symptoms including increased cough, sputum production, shortness of breath, and reduced lung function. This may reflect the underlying disease course rather than a direct drug effect.
Common
- Hemoptysis (coughing up blood) – may range from blood-streaked sputum to more significant bleeding. Hemoptysis is common in cystic fibrosis regardless of treatment; however, the forceful coughing stimulated by Bronchitol may precipitate episodes. Report significant hemoptysis to your doctor.
- Bronchospasm – narrowing of the airways causing wheezing, chest tightness, and shortness of breath. Pre-treatment with a bronchodilator significantly reduces this risk. If bronchospasm occurs despite bronchodilator use, treatment may need to be discontinued.
- Pharyngolaryngeal pain – sore throat and discomfort in the throat area, related to inhalation of the dry powder.
- Headache
- Vomiting
- Bacterial or fungal infection of the lung – respiratory tract infections may occur, including colonization or infection with new organisms. This is also common in the natural course of cystic fibrosis.
Uncommon
- Chest discomfort or chest pain
- Wheezing (without significant bronchospasm)
- Oropharyngeal discomfort – irritation or unpleasant sensations in the mouth and throat
- Productive cough with discolored sputum
- Nausea
- Diarrhea – may occur if significant amounts of mannitol are swallowed rather than inhaled
- Dysphonia (hoarseness or voice changes)
- Decreased appetite
Rare
- Severe bronchospasm requiring emergency treatment
- Pneumothorax (collapsed lung) – extremely rare but has been reported in the context of vigorous coughing in patients with advanced cystic fibrosis
- Allergic reactions to mannitol or capsule components
Seek emergency medical care if you experience severe difficulty breathing, significant coughing up of blood (more than a tablespoon), chest pain with sudden onset of breathlessness (possible pneumothorax), severe allergic reaction (rash, swelling of face or throat, difficulty breathing), or any symptom that feels life-threatening. Stop using Bronchitol and contact your doctor if side effects are severe or persistent.
If you notice any side effects not listed here, or if any side effects become serious, please tell your doctor, pharmacist, or nurse. You can also report side effects to your national pharmacovigilance authority (e.g., the Yellow Card Scheme in the UK, MedWatch in the US, or the corresponding agency in your country). Reporting side effects helps to provide more information on the safety of this medicine.
It is important to remember that your doctor has prescribed Bronchitol because the expected benefit outweighs the risk of side effects. Many patients use Bronchitol for years with good tolerability. The cough and airway clearance that the drug promotes are, in fact, part of its therapeutic action. Discuss any concerns about side effects with your healthcare team, who can advise on management strategies and help you weigh the benefits and risks of continued treatment.
How Should You Store Bronchitol?
Proper storage of Bronchitol is important to maintain the quality and effectiveness of the inhalation powder. Mannitol is a hygroscopic substance, meaning it readily absorbs moisture from the air, which can affect the powder characteristics and drug delivery performance.
- Temperature: Store at or below 30°C (86°F). Do not refrigerate or freeze. Brief exposure to temperatures outside this range (e.g., during travel) is unlikely to harm the product, but prolonged storage at elevated temperatures should be avoided.
- Moisture protection: Store capsules in the original blister packaging to protect from moisture. Only remove a capsule from the blister immediately before use. Do not store capsules loose in the inhaler device or in another container.
- Expiry date: Do not use Bronchitol after the expiry date printed on the carton and blister. The expiry date refers to the last day of that month.
- Inhaler device: The Bronchitol inhaler should be kept clean and dry. Replace the inhaler device with each new pack of capsules, or as directed by the manufacturer. Do not wash the inhaler with water; wipe it clean with a dry cloth if needed.
- Keep out of reach: Keep this medicine out of the sight and reach of children.
- Disposal: Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help to protect the environment.
What Does Bronchitol Contain?
Bronchitol has a remarkably simple formulation. Unlike many other inhaled medications that require carriers, propellants, or complex formulations, the Bronchitol inhalation powder consists solely of mannitol.
Active Ingredient
Each hard capsule for inhalation contains 40 mg of mannitol. Mannitol (also known as D-mannitol or mannite) is a naturally occurring sugar alcohol with the chemical formula C6H14O6. It is a white, odorless, crystalline powder with a slightly sweet taste. Mannitol is found naturally in many fruits and vegetables, including mushrooms, seaweed, celery, and olives. It is widely used in the pharmaceutical and food industries as an excipient, sweetener, and osmotic agent. The mannitol used in Bronchitol is spray-dried to produce particles of a specific size range optimized for deep lung deposition when inhaled through the provided device.
Other Components
- Capsule shell: The hard capsule is made of gelatin. Patients with known allergies to gelatin should inform their doctor before using Bronchitol.
- No other excipients: The inhalation powder contains no lactose, no preservatives, no propellants, and no other additives. This is unusual among inhaled medications and means that Bronchitol may be suitable for patients with lactose intolerance or sensitivity to common inhaler excipients.
The Bronchitol pack also includes a dedicated inhaler device designed specifically for use with the Bronchitol capsules. The inhaler is a breath-actuated dry powder inhaler (DPI) that does not require coordination of inhalation with device actuation, making it relatively easy to use. The patient places a capsule in the device, presses the buttons to pierce the capsule, and then inhales deeply through the mouthpiece. The capsule should spin in the device during inhalation, producing a rattling sound that confirms airflow through the capsule.
Bronchitol’s single-ingredient powder formulation is one of its distinguishing features. With no lactose carrier or other excipients, the entire inhaled dose consists of the active therapeutic agent. This simplicity reduces the risk of excipient-related adverse effects and makes the product suitable for a wide range of patients, including those with common excipient sensitivities.
Frequently Asked Questions About Bronchitol
Bronchitol (mannitol) is an inhaled dry powder mucolytic used for cystic fibrosis in adults. It works by creating an osmotic gradient on the airway surface – when you inhale the mannitol powder, it draws water from the tissue beneath the airway lining into the airway space. This rehydrates the thick, sticky mucus that characterizes cystic fibrosis, making it thinner and easier for the lungs’ natural clearing mechanisms (cilia) to move it upward and out. The drug also stimulates cough, which further helps clear mucus. The overall result is improved mucociliary clearance and measurable improvements in lung function.
The initiation dose assessment (also called a tolerance test) is a mandatory screening procedure performed in a clinical setting before you start Bronchitol. During the test, you inhale increasing doses of mannitol while a healthcare professional monitors your lung function using spirometry (measuring FEV1). The purpose is to ensure your airways do not react excessively to inhaled mannitol. If your FEV1 drops by 20% or more from baseline at any point during the test, you fail the assessment and should not use Bronchitol. This is a safety measure to identify patients who are at high risk of dangerous bronchospasm with continued use.
Yes, Bronchitol and dornase alfa work through different complementary mechanisms and can be used together as part of your cystic fibrosis treatment regimen. Dornase alfa is an enzyme that breaks down extracellular DNA in mucus, while Bronchitol hydrates the mucus through osmotic action. In clinical trials, Bronchitol showed benefits in patients both with and without concomitant dornase alfa use. Your healthcare team will advise on the timing and sequence of your inhaled therapies to optimize the benefit of each.
Each dose of Bronchitol requires inhaling the contents of 10 capsules (40 mg each). You load and inhale one capsule at a time using the provided device. This typically takes approximately 5 to 10 minutes per session, depending on your inhalation technique and whether you need to pause between capsules. While this may seem involved, many patients develop an efficient routine with practice. You should follow each session with your prescribed airway clearance techniques (chest physiotherapy) to maximize the benefit of the loosened mucus.
Yes, coughing is the most common side effect of Bronchitol and is actually an expected part of how the drug works. The osmotic effect of mannitol on the airways stimulates cough as a reflex, and this coughing helps to clear the loosened mucus from your lungs. The cough is usually productive (bringing up sputum). It tends to be most noticeable when you first start treatment and often becomes less intense over time as your body adjusts. However, if coughing is severe, persistent, distressing, or accompanied by significant amounts of blood, you should discuss this with your doctor.
Mild wheezing can occur as the airways respond to the inhaled powder. This is why a short-acting bronchodilator (like salbutamol) must always be taken 5–15 minutes before each Bronchitol dose. If you experience significant wheezing or breathlessness despite pre-treatment with your bronchodilator, stop using Bronchitol and use your rescue inhaler. Contact your doctor to discuss whether Bronchitol should be continued. In cases of severe bronchospasm with difficulty breathing, seek emergency medical attention immediately.
References
- European Medicines Agency (EMA). Bronchitol – Summary of Product Characteristics. Last updated 2025. Available at: EMA – Bronchitol EPAR.
- U.S. Food and Drug Administration (FDA). Bronchitol Prescribing Information. Approved October 2020. Available at: FDA – Bronchitol Label.
- Bilton D, Robinson P, Cooper P, et al. Inhaled dry powder mannitol in cystic fibrosis: an efficacy and safety study. European Respiratory Journal. 2011;38(5):1071–1080. doi:10.1183/09031936.00187510.
- Aitken ML, Bellon G, De Boeck K, et al. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. American Journal of Respiratory and Critical Care Medicine. 2012;185(6):645–652. doi:10.1164/rccm.201109-1666OC.
- Cystic Fibrosis Foundation. Clinical Practice Guidelines for the Management of Pulmonary Disease. Updated 2023. Available at: CFF Guidelines.
- European Cystic Fibrosis Society (ECFS). Standards of Care: Best Practice Guidelines. Updated 2024.
- Flume PA, Robinson KA, O’Sullivan BP, et al. Cystic fibrosis pulmonary guidelines: airway clearance therapies. Respiratory Care. 2009;54(4):522–537.
- Nevitt SJ, Thornton J, Murray CS, Dwyer T. Inhaled mannitol for cystic fibrosis. Cochrane Database of Systematic Reviews. 2020;(5):CD008649. doi:10.1002/14651858.CD008649.pub4.
- World Health Organization (WHO). Cystic Fibrosis Factsheet. Available at: WHO.
- Robinson M, Daviskas E, Eberl S, et al. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. European Respiratory Journal. 1999;14(3):678–685.
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