A Phase 2 interventional study of Salbutamol 5mg/mL and Sodium Chloride 0.9% Inhl 3Ml in Cough, sponsored by McMaster University. Completed at 2 sites in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-16.
Sponsored by McMaster University · Phase 2, Interventional, and Other
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.
The study will have a maximum of 4 visits separated by at least 24 hours. The first 2 visits will determine eligibility. All eligible subjects will be invited back for a third and a fourth visit.
Screening Period (Visits 1 and 2) - For All Subjects Eligible subjects will be identified during the initial screening procedures with measures of spirometry, hyperresponsiveness to methacholine, complete history, physical examination, allergen skin test, and mannitol cough challenge. The screening procedures will be conducted over 2 separate visits.
Effects of Salbutamol (Visit 3 and 4) - For Healthy Control Subjects, Twenty subjects with no evidence of asthma will return for visit 3 and 4. These visits must be at least 24h apart and no longer than 7 days. Health controls will first receive salbutamol 2.5mg or saline placebo via a nebuliser and 15 mins later the forced expiratory volume at one second (FEV1) measured. Subjects will then undergo a mannitol cough challenge exactly like the previous mannitol cough challenges. These data will be used for determining the effects of salbutamol on mannitol-induced cough.
Visit Windows Each visit must be separated by a minimum of 24 hours, and a maximum of 7 days. Study visits can be performed in the morning or afternoon, however for each subject the timing should be consistent with Visits 2 at the same time of day ± 2 hours
355 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 20 is below the median of 71 across 270 interventional studies indexed under Cough.
Browse Cough studies →McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
Healthy Controls Mannitol-Induced Cough Challenges on Visit 2 to determine elligibility (cough response). Mannitol delivered via inhalation. Dosage: 0, 5, 10, 20, 40 mg capsules. 80 and 160 mg doses delivered with two and four capsules, respectively. Nebulized salbutamol (5mg/mL) given prior to Mannitol-Induced Cough Challenges on Visit 3 or 4.
Drug: Salbutamol 5mg/mL
Healthy Controls Mannitol-Induced Cough Challenges on Visit 2 to determine elligibility (cough response). Mannitol delivered via inhalation. Dosage: 0, 5, 10, 20, 40 mg capsules. 80 and 160 mg doses delivered with two and four capsules, respectively. Nebulized 0.9% Saline given prior to Mannitol-Induced Cough Challenges on Visit 3 or 4.
Drug: Sodium Chloride 0.9% Inhl 3Ml
Drug page: Albuterol
Nebulized salbutamol given prior to Mannitol-Induced Cough Challenge
Also known as: Ventolin nebuliser
Nebulized 0.9% saline given prior to Mannitol-Induced Cough Challenge
Also known as: Placebo Comparator
Primary Outcome - Emax
The effect of salbutamol on mannitol induced coughs Emax - the maximum number of coughs at any dose of mannitol.
Time frame: Through study completion, an average of 1 year
Cough dose response curves
Comparison of mannitol-induced cough dose response curves in normal healthy controls treated with salbutamol compared with placebo.
Time frame: Through study completion, an average of 1 year
ED50
The effect of salbutamol on mannitol induced coughs E50 - the dose of mannitol causing half the maximal response.
Time frame: Through study completion, an average of 1 year
C2
Comparison of the mannitol dose causing 2 coughs (C2) in a mannitol induced cough challenge in healthy controls treated with salbutamol compared with placebo.
Time frame: Through study completion, an average of 1 year
C5
Comparison of the mannitol dose causing 5 coughs (C5) in a mannitol induced cough challenge in healthy controls treated with salbutamol compared with placebo.
Time frame: Through study completion, an average of 1 year
Cumulative number of coughs
Comparison of the cumulative number of coughs in a mannitol induced cough challenge in healthy controls treated with salbutamol compared with placebo.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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