What Is Bronchitol? Uses, Dosage, and What You Need to Know in 2026

If you or someone you care for has cystic fibrosis, you may have heard about Bronchitol — a relatively newer add-on therapy approved by the FDA in 2020. This article covers everything you need to know about Bronchitol in plain English: what it is, what it treats, how to take it, and what to expect.

What Is Bronchitol?

Bronchitol is the brand name for inhaled mannitol — a dry powder formulation of a naturally occurring sugar alcohol. It was developed by Pharmaxis Ltd. in Australia and is distributed in the United States by Chiesi USA, Inc. The FDA approved Bronchitol on October 30, 2020.

Bronchitol is described as an "add-on maintenance therapy" — it's used alongside (not instead of) your other CF treatments to improve lung function. It is indicated for adults 18 years of age and older with cystic fibrosis. It is not approved for use in children or adolescents.

What Does Bronchitol Treat?

Bronchitol treats the mucus clearance problem in cystic fibrosis. CF is caused by mutations in the CFTR gene, which leads to the production of abnormally thick, sticky mucus that clogs the airways. This mucus buildup makes breathing difficult and increases the risk of chronic lung infections.

Bronchitol helps by drawing water into the airways — the mannitol molecules attract water to the surface of the lung lining, hydrating the mucus and making it thinner and easier to clear. Clinical trials showed improvements in FEV1 (forced expiratory volume in one second), a key measure of lung function, and one trial showed a 35.4% reduction in pulmonary exacerbations (lung symptom flares).

How Is Bronchitol Taken?

Bronchitol comes as 40 mg hard gelatin capsules that you inhale using a special dry powder inhaler (provided with the medication). Here's how it works:

Dose: 400 mg twice daily — that's 10 capsules per dose (each 40 mg), inhaled individually one at a time

Timing: Once in the morning and once in the evening; the evening dose should be taken at least 2–3 hours before bedtime

Pre-medication required: You must inhale a short-acting bronchodilator (like albuterol) 5–15 minutes before every dose of Bronchitol to prevent bronchospasm

Device: Use only the Bronchitol inhaler that comes with the medication — do not swallow the capsules. Replace the inhaler after 7 days of use.

Storage: Store at room temperature (68–77°F / 20–25°C). No refrigeration required — a major convenience advantage over some other CF therapies.

The Bronchitol Tolerance Test: Why It's Required

Before Bronchitol can be prescribed, your doctor must administer the Bronchitol Tolerance Test (BTT). This is a supervised in-office test where you inhale escalating doses of mannitol while your provider monitors for bronchospasm (sudden airway tightening), drops in FEV1, or changes in oxygen levels. About 8% of patients fail this test and cannot use Bronchitol.

The BTT cannot be done at home or at a pharmacy — it must be performed in a clinical setting with bronchospasm management equipment on hand.

Key Facts About Bronchitol

Drug class: Osmotic mucoactive agent

Generic name: Mannitol (inhaled)

FDA approved: October 30, 2020 (for adults 18+ with CF)

Controlled substance: No — Bronchitol has no DEA schedule

Generic available: No — brand-name only as of late 2025

Cash price: Approximately $3,826/month without insurance

Dispensed: Specialty pharmacies only — not available at retail pharmacies

Key advantage: Compact, portable dry powder inhaler — no nebulizer, no refrigeration, no routine device cleaning

How Do I Get Bronchitol?

If your CF care team thinks Bronchitol might be right for you, the process starts with the BTT, then a prescription and prior authorization. Once your prescription is ready, medfinder can help you find a specialty pharmacy near you that can fill it.

Want to understand exactly how Bronchitol works in your body? See: How Does Bronchitol Work? Mechanism of Action Explained in Plain English.

To understand potential side effects, read: Bronchitol Side Effects: What to Expect and When to Call Your Doctor.