AsthmaNCT01064245
Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests
A study testing high-dose methacholine challenge test and mannitol challenge test in people with Asthma and Cough Variant Asthma, run by Dr. Diane Lougheed at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Cough Variant Asthma
- What is being tested?
- high-dose methacholine challenge test and mannitol challenge test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2010to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Asthma, Cough Variant Asthma
- Being tested
- high-dose methacholine challenge test, mannitol challenge test
- Keywords
- Asthma, Cough Variant Asthma, Mannitol, Methacholine, Cough, Hypersensitivity
- Medical subject headings
- Asthma, Cough-Variant Asthma, Cough, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose methacholine challenge testDrug
Also called Provocholine
nebulized liquid inhalation, 0.0625 - 256 mg/mL, doubling doses
mannitol challenge testOther
Also called Aridol
inhaled powder, 0 - 635 mg, increments of 5,10, 20 and 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Cough Variant Asthma | Experimental | Those diagnosed with cough variant asthma. Receives: Drug: high-dose methacholine challenge test; Other: mannitol challenge test |
| Asthma | Experimental | Those with diagnosed asthma. Receives: Drug: high-dose methacholine challenge test; Other: mannitol challenge test |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD15 (15% fall in forced expiratory volume in one second (FEV1) from baseline during challenge test visits)
Measured: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test)
Secondary outcomes (4)
%ΔFEV1 (percentage change in forced expiratory volume in one second)
Measured: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test)
Plateau response
Measured: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test)
Dose-response slope
Measured: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test)
Expiratory Flow Limitation (EFL)
Measured: baseline and several time points collected throughout test (high-dose methacholine challenge test or mannitol challenge test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study start1 Feb 2010
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Diane Lougheed
- Sponsor type
- University, hospital or other
- Collaborators
- The Ontario Thoracic Society of the Ontario Lung Association, Queen's University (William M Spear / Start Memorial Fund)
- Responsible party
- Sponsor-investigator, Dr. Diane Lougheed, Queen's University
- Investigators
- Diane Lougheed, MD, Principal investigator, Queen's UniversityScott Turcotte, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064245
- Sponsor's protocol ID
- 2010-01
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2010
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests
- ClinicalTrials.gov ID
- NCT01064245
- Acronym / sponsor ID
- 2010-01
- Conditions
- Asthma, Cough Variant Asthma
- Keywords
- Asthma, Cough Variant Asthma, Mannitol, Methacholine, Cough, Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dr. Diane LougheedUniversity, hospital or other
- Collaborators
- The Ontario Thoracic Society of the Ontario Lung Association, Queen's University (William M Spear / Start Memorial Fund)
- Study start
- 1 Feb 2010 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cough Variant Asthma | Experimental | Drug: high-dose methacholine challenge test, Other: mannitol challenge testThose diagnosed with cough variant asthma. |
| Asthma | Experimental | Drug: high-dose methacholine challenge test, Other: mannitol challenge testThose with diagnosed asthma. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (17 listed)
- 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:
- Smoking history in excess of 10 pack years;
- Medical contraindications to mannitol challenge testing, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-dose methacholine challenge testAlso: Provocholinenebulized liquid inhalation, 0.0625 - 256 mg/mL, doubling doses | Drug | Asthma, Cough Variant Asthma |
| mannitol challenge testAlso: Aridolinhaled powder, 0 - 635 mg, increments of 5,10, 20 and 40 mg | Other | Asthma, Cough Variant Asthma |
Primary outcome
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)
4 secondary outcomes
%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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Lougheed, MD principal investigator
Queen's University
Scott Turcotte principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-dose methacholine challenge test and mannitol challenge test in people with Asthma and Cough Variant Asthma, run by Dr. Diane Lougheed at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.