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Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests

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ClinicalTrials.gov Identifier: NCT01064245
Recruitment Status : Active, not recruiting
First Posted : February 8, 2010
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
The Ontario Thoracic Society of the Ontario Lung Association
Queen's University (William M Spear / Start Memorial Fund)
Information provided by (Responsible Party):
Dr. Diane Lougheed, Queen's University

Tracking Information
First Submitted Date  ICMJE February 1, 2010
First Posted Date  ICMJE February 8, 2010
Last Update Posted Date February 12, 2020
Study Start Date  ICMJE February 1, 2010
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2010)
PD15 (15% fall in forced expiratory volume in one second (FEV1) from baseline during challenge test visits) [ Time Frame: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2010)
  • %ΔFEV1 (percentage change in forced expiratory volume in one second) [ Time Frame: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test) ]
  • Plateau response [ Time Frame: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test) ]
  • Dose-response slope [ Time Frame: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test) ]
  • Expiratory Flow Limitation (EFL) [ Time Frame: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests
Official Title  ICMJE Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Asthma
  • Cough Variant Asthma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cough Variant Asthma
    Those diagnosed with cough variant asthma.
    Interventions:
    • Drug: high-dose methacholine challenge test
    • Other: mannitol challenge test
  • Experimental: Asthma
    Those with diagnosed asthma.
    Interventions:
    • Drug: high-dose methacholine challenge test
    • Other: mannitol challenge test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with asthma or suspected CVA who have previously participated in or who have expressed interest in participating in studies will be invited to participate in the study. Previous treatment with inhaled or systemic corticosteroids is not an exclusion criterion, but medication use will be recorded and examined in the analysis.

Exclusion Criteria:

  1. An exacerbation necessitating any alteration in medication, emergency department visit or hospitalizations within the previous 4 weeks;
  2. Inability to perform acceptable quality spirometry;
  3. Medical contraindications to methacholine challenge testing 35, including:

    1. Severe airflow limitation (FEV1 <50% predicted or <1.0 L);
    2. Heart attack or stroke in last 3 months;
    3. Uncontrolled hypertension, systolic BP > 200 or diastolic BP > 100;
    4. Known aortic aneurysm;
    5. Moderate airflow limitation < 60% predicted or <1.5 L);
    6. Inability to perform acceptable quality spirometry;
    7. Current use of cholinesterase inhibitor medication (for myasthenia gravis); and
    8. Pregnant or nursing mothers.
  4. Smoking history in excess of 10 pack years;
  5. Medical contraindications to mannitol challenge testing, including:

    1. Aortic or cerebral aneurysm;
    2. Uncontrolled hypertension; and
    3. Myocardial infarction or a cerebral vascular accident in the previous six months).
  6. Women who are pregnant or breastfeeding because the effects of a possible hyperresponsiveness reaction to mannitol in mothers and/or fetuses are unknown and many compounds are excreted in human milk therefore caution should be taken.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01064245
Other Study ID Numbers  ICMJE 2010-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Diane Lougheed, Queen's University
Study Sponsor  ICMJE Dr. Diane Lougheed
Collaborators  ICMJE
  • The Ontario Thoracic Society of the Ontario Lung Association
  • Queen's University (William M Spear / Start Memorial Fund)
Investigators  ICMJE
Principal Investigator: Diane Lougheed, MD Queen's University
Principal Investigator: Scott Turcotte Queen's University
PRS Account Queen's University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP