Trial record 8 of 2471 for:    "Asthma"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Queen's University
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):
Diane Lougheed, Queen's University
ClinicalTrials.gov Identifier:
NCT01064245
First received: February 1, 2010
Last updated: September 10, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • %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 ]

Estimated Enrollment: 24
Study Start Date: February 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064245

Contacts
Contact: Diane Lougheed, MD FRCP(C) (613) 548-2348 lougheed@kgh.kari.net

Locations
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)         
Sponsors and Collaborators
Queen's University
The Ontario Thoracic Society of the Ontario Lung Association
Queen's University (William M Spear / Start Memorial Fund)
Investigators
Principal Investigator: Diane Lougheed, MD Queen's University
Principal Investigator: Scott Turcotte Queen's University
  More Information

No publications provided

Responsible Party: Diane Lougheed, Professor of Medicine, Queen's University
ClinicalTrials.gov Identifier: NCT01064245     History of Changes
Other Study ID Numbers: 2010-01
Study First Received: February 1, 2010
Last Updated: September 10, 2013
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
Asthma
Cough Variant Asthma
Mannitol
Methacholine
Cough
Hypersensitivity

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 22, 2014