The Effects of Salbutamol on Mannitol Induced Cough Responses in Healthy Controls

• Status: Not yet recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The study aim is to investigate if changes in osmolarity using mannitol challenge can evoke coughing healthy controls with no evidence of bronchoconstriction (PC20>16mg/ml or mannitol PD15 > 635 mg, or < 10% incremental fall in FEV1 between consecutive mannitol doses) and if salbutamol can affect this. This is a double-blind, placebo-controlled analysis in healthy controls assessing the effects of salbutamol on mannitol induced cough.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: McMaster University
• Treatments: Albuterol

Criteria

Inclusion Criteria:

1. Able to understand and give written informed consent.

2. Male and female volunteers 18 through 65 years of age.

3. No airway hyperresponsiveness as determined by methacholine PC20>16mg/ml or mannitol PD15 > 635 mg, or < 10% incremental fall in FEV1 between consecutive mannitol doses.

4. Fall in FEV1 of ≤ 5% after any mannitol dose during mannitol challenge compared to baseline FEV1 at 0 mg at screening mannitol challenge (Visit 2).

5. Baseline FEV1≥ 80% of the predicted value.

6. Demonstrate cough response to inhaled mannitol.

Exclusion Criteria:

1. Current or former smoker with >10-pack-year history

2. Current or previous history of other significant respiratory disease

3. Significant systemic disease, including history of current malignancy or autoimmune disease

4. Pregnancy or breastfeeding.

5. Use of corticosteroids within 28 days prior to the first study visit.

6. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours of study visits or aspirin with 7 days of study visits

7. Use of antihistamines including those in cold and allergy medications within 72 hours of study visits

8. Use of caffeine-containing products within 4 hours of study visits

9. Use of ACE inhibitors

10. Any centrally acting medication which in the view of the investigator could alter the sensitivity of the cough reflex including but not restricted to tricyclic anti-depressants, pregabalin, gabapentin, codeine, tramadol, or any other opioid.

11. Unwillingness or inability to comply with the study protocol for any other reason