The Effects of Salbutamol on Mannitol Induced Cough Responses in Healthy Controls (NCT04565847) | Clinical Trial Compass
CompletedPhase 2
The Effects of Salbutamol on Mannitol Induced Cough Responses in Healthy Controls
Canada20 participantsStarted 2020-11-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Able to understand and give written informed consent.
✓. Male and female volunteers 18 through 65 years of age.
✓. 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.
✓. 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).
✓. Baseline FEV1≥ 80% of the predicted value.
✓. Demonstrate cough response to inhaled mannitol.
Exclusion criteria
✕. Current or former smoker with \>10-pack-year history
✕. Current or previous history of other significant respiratory disease
✕. Significant systemic disease, including history of current malignancy or autoimmune disease
✕. Pregnancy or breastfeeding.
✕. Use of corticosteroids within 28 days prior to the first study visit.
✕. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 48 hours of study visits or aspirin with 7 days of study visits
✕. Use of antihistamines including those in cold and allergy medications within 72 hours of study visits
What they're measuring
1
Primary Outcome - Emax
Timeframe: Through study completion, an average of 1 year