BRONCHITOL® (mannitol) inhalation powderTolerance Test
Before starting patients on BRONCHITOL, a trained healthcare practitioner must administer the BRONCHITOL Tolerance Test (BTT)1
Purposes of the BTT:
- Identify patients who may be hyperresponsive to BRONCHITOL to ensure that only appropriate patients are prescribed treatment
- Enable patients to practice the correct inhaler technique before receiving their BRONCHITOL prescription
The BTT involves:
- Obtaining baseline measurements of SpO2 and FEV1
- Administration of a bronchodilator
- A series of monitored inhalations of increasing doses of BRONCHITOL
- Measurement of FEV1 and SpO2 after each step for comparison to respective calculated STOP values
This is a summary of the steps; please see the Healthcare Practitioner Instructions for Use (HCP IFU) for fulldirections 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.
How to administer the BTT
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 capsuleat a time, and proper inhalation technique, especially how to minimize irritant cough.
See the Healthcare Practitioner Instructions for Use for more information.
Frequently Asked Questions1
- The BRONCHITOL Tolerance Test (BTT) identifies patients who are hyperresponsive to inhaled mannitol, the active ingredient in BRONCHITOL, through a series of monitored inhalations of increasing doses
- Because of the risk of bronchospasm, prior to prescribing BRONCHITOL, the BTT is used to identify patients who are appropriate for maintenance treatment with BRONCHITOL. In clinical trials, 824 of 896 (92%) adult patients with cystic fibrosis passed the BTT. Do not prescribe BRONCHITOL if the patient fails the BTT
- The BTT is used to identify patients who have SpO2 or FEV1 measurements that fall below the STOP values calculated in the HCP IFU, show any signs of significant bronchoconstriction requiring treatment with a bronchodilator, such as wheezing or shortness of breath, experience a distressing cough, vomiting, or any other signs that they are not tolerating BRONCHITOL. If a patient experiences any of these events during the BTT, the patient has failed the BTT and should not be prescribed BRONCHITOL. If a patient does not experience any of these events during the BTT, the patient has passed the BTT and is a candidate for BRONCHITOL therapy
- Before performing the BTT, ensure that rescue medication and resuscitation equipment are available for immediate use during the BTT if needed. The BTT must be administered under the supervision of a healthcare practitioner who can treat severe bronchospasm. Do not perform the BTT if the patient is considered clinically unstable
- If a patient has not inhaled the contents of a total of 10 capsules during STEPS C through F of the BTT, the BTT should be stopped and a repeat BTT should be scheduled
- Bronchospasm may occur during inhalation of BRONCHITOL, either during the BTT or after the BTT during maintenance therapy. An inhaled short-acting bronchodilator must be administered 5–15 minutes before administration of each dose during ongoing daily therapy
- In clinical studies, bronchospasm or bronchial hyperreactivity was reported in 4 of 414 adult patients (1.0%) receiving BRONCHITOL even though these patients were not determined to be hyperresponsive to BRONCHITOL during the BTT. If bronchospasm occurs following dosing of BRONCHITOL, it should immediately be discontinued and treated with an inhaled short-acting bronchodilator or as medically appropriate
- Other serious adverse reactions occurring with greater than 1% incidence and more frequently in BRONCHITOL-treated adult patients compared to control-treated patients were CF exacerbations (13.3% vs. 11.2%), hemoptysis (1.4% vs. 1.2%), and lower respiratory tract infection (1.2% vs 0.9%). The proportion of patients who prematurely discontinued study drug due to adverse reactions was 12.3% for patients treated with BRONCHITOL and 8.6% for patients treated with control
- The BTT is normally performed only once for a specific CF patient and must be passed before BRONCHITOL is prescribed for daily use. The BTT must be administered under the supervision of a healthcare practitioner who can treat severe bronchospasm. In clinical trials, 824 of 896 (92%) adult patients with cystic fibrosis passed the BTT. Do not prescribe BRONCHITOL if the patient fails the BTT. If a patient has not inhaled the contents of a total of 10 capsules during STEPS C through F of the BTT, the BTT should be stopped and a repeat BTT should be scheduled
See the BTT Healthcare Practitioner Instructions for Use (HCP IFU) for complete instructions, and to avoid medication errors associated with BTT dosing and procedures.
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.