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 :
Completed
First Posted : February 8, 2010
Last Update Posted : February 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma Cough Variant Asthma | Drug: high-dose methacholine challenge test Other: mannitol challenge test | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests |
Actual Study Start Date : | February 1, 2010 |
Actual Primary Completion Date : | December 31, 2021 |
Actual Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Cough Variant Asthma
Those diagnosed with cough variant asthma.
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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 |
- 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) ]
- %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) ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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:
- An exacerbation necessitating any alteration in medication, emergency department visit or hospitalizations within the previous 4 weeks;
- Inability to perform acceptable quality spirometry;
-
Medical contraindications to methacholine challenge testing 35, including:
- Severe airflow limitation (FEV1 <50% predicted or <1.0 L);
- Heart attack or stroke in last 3 months;
- Uncontrolled hypertension, systolic BP > 200 or diastolic BP > 100;
- Known aortic aneurysm;
- Moderate airflow limitation < 60% predicted or <1.5 L);
- Inability to perform acceptable quality spirometry;
- Current use of cholinesterase inhibitor medication (for myasthenia gravis); and
- Pregnant or nursing mothers.
- Smoking history in excess of 10 pack years;
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Medical contraindications to mannitol challenge testing, including:
- Aortic or cerebral aneurysm;
- Uncontrolled hypertension; and
- Myocardial infarction or a cerebral vascular accident in the previous six months).
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064245
Canada, Ontario | |
Kingston General Hospital | |
Kingston, Ontario, Canada, K7L2V7 |
Principal Investigator: | Diane Lougheed, MD | Queen's University | |
Principal Investigator: | Scott Turcotte | Queen's University |
Responsible Party: | Dr. Diane Lougheed, Professor of Medicine, Queen's University |
ClinicalTrials.gov Identifier: | NCT01064245 |
Other Study ID Numbers: |
2010-01 |
First Posted: | February 8, 2010 Key Record Dates |
Last Update Posted: | February 28, 2022 |
Last Verified: | February 2022 |
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 Mannitol Methacholine Chloride Diuretics, Osmotic |
Diuretics Natriuretic Agents Physiological Effects of Drugs Miotics Autonomic Agents Peripheral Nervous System Agents Parasympathomimetics Bronchoconstrictor Agents Respiratory System Agents Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |