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Healthy Controls for Cough (MICC Trial)

N/A
Waitlist Available
Led By Gail Gauvreau, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of one year
Awards & highlights

MICC Trial Summary

The study aim is to investigate if changes in osmolarity using mannitol challenge can evoke coughing reproducibly in mild allergic asthmatics compared with healthy controls and if salbutamol can affect this. Phase 1 of this study is a reproducibility analysis of cough dose response to mannitol in a cohort of mild allergic asthmatics and healthy controls. Phase 2 is a double-blind, placebo-controlled analysis in mild allergic asthmatics assessing the effects of salbutamol on mannitol induced cough.

Eligible Conditions
  • Cough
  • Asthma

MICC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ED50 dose response curve
Secondary outcome measures
ED50 (post-bronchodilator) dose response curve

MICC Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Healthy ControlsExperimental Treatment1 Intervention
Mannitol-Induced Cough Challenges on Visit 2 and 3. Mannitol delivered via inhalation. Dosage: 0, 5, 10, 20, 40 mg capsules. 80 and 160 mg doses delivered with two and four capsules, respectively.
Group II: Mild Allergic Asthmatics (Salbutamol)Active Control2 Interventions
Mannitol-Induced Cough Challenges on Visit 2, 3 and 4. Nebulized salbutamol (5mg/mL) given prior to Mannitol-Induced Cough Challenges on Visit 3 or 4. Mannitol delivered via inhalation. Dosage: 0, 5, 10, 20, 40 mg capsules. 80 and 160 mg doses delivered with two and four capsules, respectively.
Group III: Mild Allergic Asthmatics (Saline)Placebo Group2 Interventions
Mannitol-Induced Cough Challenges on Visit 2, 3 and 4. Nebulized placebo (Sodium Chloride 0.9% Inhl 3Ml) given prior to Mannitol-Induced Cough Challenges on Visit 3 or 4. Mannitol delivered via inhalation. Dosage: 0, 5, 10, 20, 40 mg capsules. 80 and 160 mg doses delivered with two and four capsules, respectively.

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Who is running the clinical trial?

SyntaraIndustry Sponsor
34 Previous Clinical Trials
3,049 Total Patients Enrolled
1 Trials studying Cough
30 Patients Enrolled for Cough
AllerGen NCE Inc.Industry Sponsor
8 Previous Clinical Trials
336 Total Patients Enrolled
McMaster UniversityLead Sponsor
890 Previous Clinical Trials
2,605,392 Total Patients Enrolled
5 Trials studying Cough
174 Patients Enrolled for Cough

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Mannitol-Induced Cough Challenge in Healthy Controls and Subjects With Mild Allergic Asthma
2019. "Mannitol-Induced Cough Challenge in Healthy Controls and Subjects With Mild Allergic Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03620422.
~6 spots leftby May 2025
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