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

April 19, 2016 updated by: Don Cockcroft, University of Saskatchewan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N0W8
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen
400mg (2X200mg) ibuprofen single dose once
Drug: ibuprofen
2x 200mg ibuprofen, single dose, blinded in 00 capsules
Other Names:
  • Advil
Placebo Comparator: Placebo
identical appearing lactose capsules single dose 2 capsules once
Drug: Placebo
lactose filled 00 capsules to match appearance of ibuprofen intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at time of allergen inhalation challenge and for 7 hours after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway response to inhaled methacholine
Time Frame: day before allergen inhalation challenge and 8 hours after allergen inhalation challenge
delta log methacholine PC20 (provocative concentration of methacholine causing a 20% decrease in the forced expiratory volume in one second)
day before allergen inhalation challenge and 8 hours after allergen inhalation challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 19, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio REB 14-283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

journal publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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