AsthmaNCT00424580
Airway Responses to Montelukast and Desloratadine.
A study testing Montelukast (10mg) and Desloratadine (5mg) in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their current uses. Part of what happens when your allergies trigger your asthma should be prevented by either of these drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast (10mg) and Desloratadine (5mg)
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Aug 2007
- 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
- baseline FEV1 > or = 65% predicted
- positive methacholine challenge (i.e. methacholine PC20 < or = 16mg/ml
- positive allergen challenge
Who cannot join
- negative skin prick test
- lung condition/disease other than asthma
- currently use montelukast and/or desloratadine
Trial locations and contacts
1 site in 1 country.
About this study
Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their current uses. Part of what happens when your allergies trigger your asthma should be prevented by either of these drugs. This project is being conducted to determine if these drugs are effective, either alone or in combination, on controlling asthma that is triggered by allergies.
- Conditions
- Asthma
- Being tested
- Montelukast (10mg) and Desloratadine (5mg)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast (10mg) and Desloratadine (5mg)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Late asthmatic response (maximum percent decrease in FEV1)
Secondary outcomes (3)
Early asthmatic response (maximum percent decrease in FEV1
Changes in sputum cell/mediator content
Changes in airway hyperresponsiveness (methacholine PC20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionAug 2007
- Study completionAug 2007
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Investigators
- Donald W Cockcroft, MD, FRCP(C), Principal investigator, University of Saskatchew Full Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424580
- Sponsor's protocol ID
- BIO-REB# 06-232
- Status last verified
- Jan 2008
- First submitted
- 18 Jan 2007
- Last updated
- 23 Jan 2008
- Results posted
- No
Publications
Davis BE, Illamperuma C, Gauvreau GM, Watson RM, O'Byrne PM, Deschesnes F, Boulet LP, Cockcroft DW. Single-dose desloratadine and montelukast and allergen-induced late airway responses. Eur Respir J. 2009 Jun;33(6):1302-8. doi: 10.1183/09031936.00169008. Epub 2009 Jan 22.
PubMed 19164343
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Responses to Montelukast and Desloratadine.
- ClinicalTrials.gov ID
- NCT00424580
- Acronym / sponsor ID
- BIO-REB# 06-232
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 19 Jan 2007 (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.
Montelukast (for asthma) and desloratadine (for allergies) are effective therapy for their current uses. Part of what happens when your allergies trigger your asthma should be prevented by either of these drugs. This project is being conducted to determine if these drugs are effective, either alone or in combination, on controlling asthma that is triggered by allergies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- baseline FEV1 > or = 65% predicted
- positive methacholine challenge (i.e. methacholine PC20 < or = 16mg/ml
- positive allergen challenge
Key exclusion criteria (3 listed)
- negative skin prick test
- lung condition/disease other than asthma
- currently use montelukast and/or desloratadine
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 |
|---|---|---|
| Montelukast (10mg) and Desloratadine (5mg) | Drug | – |
Primary outcome
Late asthmatic response (maximum percent decrease in FEV1)
3 secondary outcomes
Early asthmatic response (maximum percent decrease in FEV1
Changes in sputum cell/mediator content
Changes in airway hyperresponsiveness (methacholine PC20)
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 23 Jan 2008.
- Derived from this study: PubMed 19164343Davis BE, Illamperuma C, Gauvreau GM, Watson RM, O'Byrne PM, Deschesnes F, Boulet LP, Cockcroft DW. Single-dose desloratadine and montelukast and allergen-induced late airway responses. Eur Respir J. 2009 Jun;33(6):1302-8. doi: 10.1183/09031936.00169008. Epub 2009 Jan 22.
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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, FRCP(C) principal investigator
University of Saskatchew Full Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast (10mg) and Desloratadine (5mg) 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 3 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 23 Jan 2008. 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?
Late asthmatic response (maximum percent decrease in FEV1). 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 NCT00424580, 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 23 Jan 2008.