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

This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT01064245
First received: February 1, 2010
Last updated: March 28, 2016
Last verified: March 2016
History of Changes

February 1, 2010
March 28, 2016
February 2010
January 2017   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01064245 on ClinicalTrials.gov Archive Site
  • %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) ] [ Designated as safety issue: No ]
  • Plateau response [ Time Frame: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test) ] [ Designated as safety issue: No ]
  • Dose-response slope [ Time Frame: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test) ] [ Designated as safety issue: No ]
  • Expiratory Flow Limitation (EFL) [ Time Frame: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests
Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Asthma
  • 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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
December 2017
January 2017   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01064245
2010-01
No
Not Provided
Not Provided
Dr. Diane Lougheed, Queen's University
Queen's University
  • The Ontario Thoracic Society of the Ontario Lung Association
  • Queen's University (William M Spear / Start Memorial Fund)
Principal Investigator: Diane Lougheed, MD Queen's University
Principal Investigator: Scott Turcotte Queen's University
Queen's University
March 2016

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