Atopic AsthmaNCT02327234
Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma
A study testing ibuprofen in people with Atopic Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atopic Asthma
- What is being tested?
- ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to Apr 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mild asthma, currently well controlled requiring only a bronchodilator (e.g. salbutamol) as needed and infrequently
- has allergies that trigger asthma
- responds to methacholine challenge at 16mg/ml or less
- has FEV1 > 69.5% predicted
Who cannot join
- respiratory illness within 4 weeks
- other medical condition assessed by the principal investigator that would put the participant at risk or influence the integrity of the data
- pregnant or lactating females
- hypersensitivity to ibuprofen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process
The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.
- Conditions
- Atopic Asthma
- Being tested
- ibuprofen, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
Also called Advil
2x 200mg ibuprofen, single dose, blinded in 00 capsules
PlaceboDrug
lactose filled 00 capsules to match appearance of ibuprofen intervention
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | 400mg (2X200mg) ibuprofen single dose once Receives: Drug: ibuprofen |
| Placebo | Placebo comparator | identical appearing lactose capsules single dose 2 capsules once Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway response to inhaled allergen
area under forced expiratory volume in one second versus time curve; 0-3hours (early response) and 3-7 hours (late response)
Measured: at time of allergen inhalation challenge and for 7 hours after
Secondary outcomes (1)
Airway response to inhaled methacholine
delta log methacholine PC20 (provocative concentration of methacholine causing a 20% decrease in the forced expiratory volume in one second)
Measured: day before allergen inhalation challenge and 8 hours after allergen inhalation challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionApr 2015
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 Atopic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Cockcroft, University of Saskatchewan
- Investigators
- Don Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327234
- Sponsor's protocol ID
- Bio REB 14-283
- Status last verified
- Apr 2016
- First submitted
- 17 Dec 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: journal publication
Publications
Nomani S, Cockcroft DW, Davis BE. Allergen inhalation challenge, refractoriness and the effects of ibuprofen. Allergy Asthma Clin Immunol. 2016 May 24;12:24. doi: 10.1186/s13223-016-0127-z. eCollection 2016.
PubMed 27222654
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process
- ClinicalTrials.gov ID
- NCT02327234
- Acronym / sponsor ID
- Bio REB 14-283
- Conditions
- Atopic Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Dec 2014 (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 study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: ibuprofen400mg (2X200mg) ibuprofen single dose once |
| Placebo | Placebo comparator | Drug: Placeboidentical appearing lactose capsules single dose 2 capsules once |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of mild asthma, currently well controlled requiring only a bronchodilator (e.g. salbutamol) as needed and infrequently
- has allergies that trigger asthma
- responds to methacholine challenge at 16mg/ml or less
- has FEV1 > 69.5% predicted
Key exclusion criteria (4 listed)
- respiratory illness within 4 weeks
- other medical condition assessed by the principal investigator that would put the participant at risk or influence the integrity of the data
- pregnant or lactating females
- hypersensitivity to ibuprofen
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 |
|---|---|---|
| ibuprofenAlso: Advil2x 200mg ibuprofen, single dose, blinded in 00 capsules | Drug | Ibuprofen |
| Placebolactose filled 00 capsules to match appearance of ibuprofen intervention | Drug | Placebo |
Primary outcome
Airway response to inhaled allergen
Time frame: at time of allergen inhalation challenge and for 7 hours after
area under forced expiratory volume in one second versus time curve; 0-3hours (early response) and 3-7 hours (late response)
1 secondary outcome
Airway response to inhaled methacholine
Time frame: day before allergen inhalation challenge and 8 hours after allergen inhalation challenge
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 20 Apr 2016.
- Derived from this study: PubMed 27222654Nomani S, Cockcroft DW, Davis BE. Allergen inhalation challenge, refractoriness and the effects of ibuprofen. Allergy Asthma Clin Immunol. 2016 May 24;12:24. doi: 10.1186/s13223-016-0127-z. eCollection 2016.
- Individual participant dataSharing planned: Yes. journal publication
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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.
Don 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 ibuprofen in people with Atopic 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 4 inclusion and 4 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 20 Apr 2016. 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. Some participants in this study may receive a placebo. 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?
Airway response to inhaled allergen (time frame: at time of allergen inhalation challenge and for 7 hours after). 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 NCT02327234, 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 20 Apr 2016.