AsthmaNCT00890539
Methacholine Challenge: Comparison of Doubling and Quadrupling Methacholine Dose Regimes Using the Tidal Volume Method
A study testing Methacholine challenge in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The purpose of this study is to determine the difference (if any) in the result of the methacholine challenge (a test used by physicians in diagnosing asthma) when concentrations of methacholine are quadrupled versus doubled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Methacholine challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Mar 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You must be over 18 years of age; and
- You must have a diagnosis of asthma; and
- Excluding asthma, you are not aware of any other lung conditions or diseases.
Who cannot join
- You have a known hypersensitivity (i.e. an overreaction of your immune system) to methacholine or other parasympathomimetic agents or cholinesterase inhibitors (i.e. agents that act in a similar way via your nervous system - to be discussed with study personnel); or
- You are a nursing mother or if you are a woman of child bearing potential who is, may be, or intends to become pregnant during testing as the effects of methacholine inhalation in these situations are not known; or
- Your baseline lung function is poor (ie. your FEV or forced expiratory volume in one second, is less than 65% of your predicted values). This will be performed and explained by study personnel prior to commencing methacholine inhalation testing; or
- You have had any respiratory infections for the last four weeks; or
- If you have allergies, and have been exposed to agents that trigger your asthma within the last four weeks; or
- If you have any significant chronic medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the difference (if any) in the result of the methacholine challenge (a test used by physicians in diagnosing asthma) when concentrations of methacholine are quadrupled versus doubled.
Read the detailed description
The purpose of this study is to confirm that the tidal volume technique of methacholine delivery may be employed in methacholine challenges using a quadrupling dose schedule instead of the standard doubling dose schedule with similar diagnostic efficacy, with no increase in patient adverse events, and with a shorter investigational duration. This has previously been shown to be true using the dosimeter technique of methacholine challenge.
- Conditions
- Asthma
- Being tested
- Methacholine challenge
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine challengeDrug
Clinical and research test used in asthma
| Study group | Role | What they receive |
|---|---|---|
| Quadrupling | Experimental | methacholine challenge using quadrupling concentrations Receives: Drug: Methacholine challenge |
| doubling | Active comparator | doubling concentrations of methacholine Receives: Drug: Methacholine challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine PC20
Measured: 1 week
Secondary outcomes (1)
Subject measure of breathlessness - modified Borg scale
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 2009
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Investigators
- Donald W Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890539
- Sponsor's protocol ID
- BMC08-247
- Status last verified
- Nov 2009
- First submitted
- 2 Mar 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methacholine Challenge: Comparison of Doubling and Quadrupling Methacholine Dose Regimes Using the Tidal Volume Method
- ClinicalTrials.gov ID
- NCT00890539
- Acronym / sponsor ID
- BMC08-247
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 30 Apr 2009 (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.
The purpose of this study is to determine the difference (if any) in the result of the methacholine challenge (a test used by physicians in diagnosing asthma) when concentrations of methacholine are quadrupled versus doubled.
Detailed description
The purpose of this study is to confirm that the tidal volume technique of methacholine delivery may be employed in methacholine challenges using a quadrupling dose schedule instead of the standard doubling dose schedule with similar diagnostic efficacy, with no increase in patient adverse events, and with a shorter investigational duration. This has previously been shown to be true using the dosimeter technique of methacholine challenge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrupling | Experimental | Drug: Methacholine challengemethacholine challenge using quadrupling concentrations |
| doubling | Active comparator | Drug: Methacholine challengedoubling concentrations of methacholine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- You must be over 18 years of age; and
- You must have a diagnosis of asthma; and
- Excluding asthma, you are not aware of any other lung conditions or diseases.
Key exclusion criteria (6 listed)
- You have a known hypersensitivity (i.e. an overreaction of your immune system) to methacholine or other parasympathomimetic agents or cholinesterase inhibitors (i.e. agents that act in a similar way via your nervous system - to be discussed with study personnel); or
- You are a nursing mother or if you are a woman of child bearing potential who is, may be, or intends to become pregnant during testing as the effects of methacholine inhalation in these situations are not known; or
- Your baseline lung function is poor (ie. your FEV or forced expiratory volume in one second, is less than 65% of your predicted values). This will be performed and explained by study personnel prior to commencing methacholine inhalation testing; or
- You have had any respiratory infections for the last four weeks; or
- If you have allergies, and have been exposed to agents that trigger your asthma within the last four weeks; or
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 |
|---|---|---|
| Methacholine challengeClinical and research test used in asthma | Drug | Quadrupling, doubling |
Primary outcome
Methacholine PC20
Time frame: 1 week
1 secondary outcome
Subject measure of breathlessness - modified Borg scale
Time frame: 1 week
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 25 Nov 2009.
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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.
Donald W Cockcroft, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methacholine challenge in people with Asthma, run by University of Saskatchewan 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 3 inclusion and 6 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 25 Nov 2009. 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?
Methacholine PC20 (time frame: 1 week). 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 25 Nov 2009.