Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma

NCT ID: NCT02327234

Last Updated: 2016-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-04-30

Brief Summary

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The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.

Detailed Description

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Conditions

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Atopic Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ibuprofen

400mg (2X200mg) ibuprofen single dose once

Group Type EXPERIMENTAL

ibuprofen

Intervention Type DRUG

2x 200mg ibuprofen, single dose, blinded in 00 capsules

Placebo

identical appearing lactose capsules single dose 2 capsules once

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

lactose filled 00 capsules to match appearance of ibuprofen intervention

Interventions

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ibuprofen

2x 200mg ibuprofen, single dose, blinded in 00 capsules

Intervention Type DRUG

Placebo

lactose filled 00 capsules to match appearance of ibuprofen intervention

Intervention Type DRUG

Other Intervention Names

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Advil

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Don Cockcroft

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Don Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 27222654 (View on PubMed)

Other Identifiers

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Bio REB 14-283

Identifier Type: -

Identifier Source: org_study_id

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