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| Sponsor: | Queen's University |
|---|---|
| Information provided by: | Queen's University |
| ClinicalTrials.gov Identifier: | NCT01064245 |
Purpose
Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.
| Condition | Intervention |
|---|---|
|
Asthma Cough Variant Asthma |
Drug: high-dose methacholine challenge test Other: mannitol challenge test |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests |
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cough Variant Asthma
Those diagnosed with cough variant asthma.
|
Drug: high-dose methacholine challenge test
nebulized liquid inhalation, 0.0625 - 256 mg/mL, doubling doses
Other Name: Provocholine
Other: mannitol challenge test
inhaled powder, 0 - 635 mg, increments of 5,10, 20 and 40 mg
Other Name: Aridol
|
|
Experimental: Asthma
Those with diagnosed asthma.
|
Drug: high-dose methacholine challenge test
nebulized liquid inhalation, 0.0625 - 256 mg/mL, doubling doses
Other Name: Provocholine
Other: mannitol challenge test
inhaled powder, 0 - 635 mg, increments of 5,10, 20 and 40 mg
Other Name: Aridol
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Medical contraindications to methacholine challenge testing 35, including:
Medical contraindications to mannitol challenge testing, including:
Contacts and Locations| Contact: Diane Lougheed, MD FRCP(C) | (613) 548-2348 | lougheed@kgh.kari.net |
| Canada, Ontario | |
| Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L2V7 | |
| Contact: Diane Lougheed, MD FRCP (C) (613) 548-2348 lougheed@kgh.kari.net | |
| Principal Investigator: Diane Lougheed, MD FRCP(C) | |
| Principal Investigator: | Diane Lougheed, MD | Queen's University |
| Principal Investigator: | Scott Turcotte | Queen's University |
More Information
| Responsible Party: | Diane Lougheed, MD FRCP(C), Queen's University and Kingston General Hospital |
| ClinicalTrials.gov Identifier: | NCT01064245 History of Changes |
| Other Study ID Numbers: | 2010-01 |
| Study First Received: | February 1, 2010 |
| Last Updated: | March 25, 2011 |
| Health Authority: | Canada: Health Canada |
|
Asthma Cough Variant Asthma Mannitol |
Methacholine Cough Hypersensitivity |
|
Asthma Cough Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiration Disorders Signs and Symptoms, Respiratory Signs and Symptoms Mannitol Methacholine Chloride |
Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Miotics Autonomic Agents Peripheral Nervous System Agents Parasympathomimetics Bronchoconstrictor Agents Respiratory System Agents Muscarinic Agonists Cholinergic Agonists |