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Purposes of the BTT:
A healthcare practitioner must perform the BTT and be able to manage acute bronchospasm, if it were to occur.
The BTT involves:
This is a summary of the steps; please see the Healthcare Practitioner Instructions for Use (HCP IFU) for full
directions on administering the BTT.*In the BRONCHITOL clinical trials, the BTT was performed under medical supervision.
Patients should not be left unattended during the BTT. The Healthcare Practitioner Instructions for Use are included in the Full Prescribing Information.
Lauren Cardoni, FNP-C at Brigham and Women's Hospital in Boston, discusses the BRONCHITOL Tolerance Test, its purpose, and the steps to follow while conducting it.
Watch a video that shows how to perform the Tolerance Test, which is required before prescribing BRONCHITOL for your patient.
Instruct your patients on safe hygiene practices and correct inhaler use, including loading of one capsule
at a time, and proper inhalation technique, especially how to minimize irritant cough.See the Healthcare Practitioner Instructions for Use for more information.
See the BTT Healthcare Practitioner Instructions for Use (HCP IFU) for complete instructions, and to avoid medication errors associated with BTT dosing and procedures.
Learn more about dosing and administration
BRONCHITOL is not intended to be used as a rescue medication. Inhaler and blister pack are not actual size and are for representation only. Use an inhaled bronchodilator 5–15 minutes before taking BRONCHITOL.
BRONCHITOL is contraindicated in patients with hypersensitivity to mannitol or to any of the capsule components. BRONCHITOL is contraindicated in patients who fail to pass the BRONCHITOL Tolerance Test (BTT).
BRONCHITOL can cause bronchospasm, which can be severe in susceptible patients. Because of the risk of bronchospasm, prior to prescribing BRONCHITOL, patients must pass the BRONCHITOL Tolerance Test (BTT). The BTT must be administered under the supervision of a healthcare practitioner who can treat severe bronchospasm.
Patients who pass the BRONCHITOL tolerance test (BTT) may experience bronchospasm with add-on maintenance therapy with BRONCHITOL. Patients should premedicate with an inhaled short-acting bronchodilator prior to each administration of BRONCHITOL. If bronchospasm occurs, immediately discontinue BRONCHITOL and treat bronchospasm with an inhaled short-acting bronchodilator.
Hemoptysis can occur with BRONCHITOL use. Monitor patients with history of episodes of hemoptysis. If hemoptysis occurs, discontinue use of BRONCHITOL.
Most common adverse reactions (≥3%) include cough, hemoptysis, oropharyngeal pain, vomiting, bacteria sputum identified, pyrexia, and arthralgia.
BRONCHITOL® (mannitol) inhalation powder is a sugar alcohol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis. Use BRONCHITOL only in adults who have passed the BRONCHITOL Tolerance Test.
Reference: 1. BRONCHITOL® (mannitol) inhalation powder Prescribing Information. 2020.
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