Allergic AsthmaNCT01699594
Change in Airway Responsiveness After Allergen Exposure
A study testing Mannitol and Methacholine Chloride in people with Allergic Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Mannitol and Methacholine Chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to May 2014
- 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
- mild, allergic asthma
- FEV1 greater than 70% predicted
- methacholine PC20 less than or equal to 16mg/ml
Who cannot join
- known sensitivity to mannitol or other excipient
- diagnosis of any other respiratory or non respiratory disease/disorder that would preclude the individual from participating
- recent thoracic, abdominal or eye surgery
- recent allergen exposure (4 weeks), respiratory infection (6 weeks)
- current immunotherapy
- pregnancy
- history of anaphylaxis
- use of asthma therapies other than short acting beta agonist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity
Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine).
- Conditions
- Allergic Asthma
- Being tested
- Mannitol, Methacholine Chloride
- Keywords
- asthma, allergies, mannitol, methacholine
- Medical subject headings
- Asthma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Also called Aridol
Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
Methacholine ChlorideDrug
Also called Provocholine
Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
| Study group | Role | What they receive |
|---|---|---|
| Mannitol | Experimental | This arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation. Receives: Drug: Mannitol |
| Methacholine Chloride | Active comparator | This arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation. Receives: Drug: Methacholine Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in airway responsiveness three hours after allergen exposure
Measured: Change from Baseline at 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald W Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699594
- Sponsor's protocol ID
- IIS-A-524
- Other IDs
- BioReb #10-227
- Status last verified
- Oct 2013
- First submitted
- 1 Oct 2012
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Amakye DO, Davis BE, Martin AL, Peters GE, Cockcroft DW. Refractoriness to inhaled mannitol 3 hours after allergen challenge. Ann Allergy Asthma Immunol. 2013 Sep;111(3):182-4. doi: 10.1016/j.anai.2013.06.011. Epub 2013 Jul 12.
PubMed 23987192
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity
- ClinicalTrials.gov ID
- NCT01699594
- Acronym / sponsor ID
- IIS-A-524
- Conditions
- Allergic Asthma
- Keywords
- asthma, allergies, mannitol, methacholine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Oct 2012 (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.
Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannitol | Experimental | Drug: MannitolThis arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation. |
| Methacholine Chloride | Active comparator | Drug: Methacholine ChlorideThis arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mild, allergic asthma
- FEV1 greater than 70% predicted
- methacholine PC20 less than or equal to 16mg/ml
Key exclusion criteria (8 listed)
- known sensitivity to mannitol or other excipient
- diagnosis of any other respiratory or non respiratory disease/disorder that would preclude the individual from participating
- recent thoracic, abdominal or eye surgery
- recent allergen exposure (4 weeks), respiratory infection (6 weeks)
- current immunotherapy
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 |
|---|---|---|
| MannitolAlso: AridolIndirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine) | Drug | Mannitol |
| Methacholine ChlorideAlso: ProvocholineDirect bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol) | Drug | Methacholine Chloride |
Primary outcome
Change from baseline in airway responsiveness three hours after allergen exposure
Time frame: Change from Baseline at 3 hours
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 9 Apr 2015.
- Derived from this study: PubMed 23987192Amakye DO, Davis BE, Martin AL, Peters GE, Cockcroft DW. Refractoriness to inhaled mannitol 3 hours after allergen challenge. Ann Allergy Asthma Immunol. 2013 Sep;111(3):182-4. doi: 10.1016/j.anai.2013.06.011. Epub 2013 Jul 12.
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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 Mannitol and Methacholine Chloride in people with Allergic 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 8 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 9 Apr 2015. 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?
Change from baseline in airway responsiveness three hours after allergen exposure (time frame: Change from Baseline at 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699594, which also lists 1 linked publication.
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 9 Apr 2015.