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

Primary Purpose

Atopic Asthma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ibuprofen
Placebo
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atopic Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ibuprofen

Placebo

Arm Description

400mg (2X200mg) ibuprofen single dose once

identical appearing lactose capsules single dose 2 capsules once

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
December 17, 2014
Last Updated
April 19, 2016
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT02327234
Brief Title
Airway Response to Repeat Allergen Challenge and the Effect of Ibuprofen in Mild Atopic Asthma
Official Title
Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
400mg (2X200mg) ibuprofen single dose once
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
identical appearing lactose capsules single dose 2 capsules once
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Other Intervention Name(s)
Advil
Intervention Description
2x 200mg ibuprofen, single dose, blinded in 00 capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
lactose filled 00 capsules to match appearance of ibuprofen intervention
Primary Outcome Measure Information:
Title
Airway response to inhaled allergen
Description
area under forced expiratory volume in one second versus time curve; 0-3hours (early response) and 3-7 hours (late response)
Time Frame
at time of allergen inhalation challenge and for 7 hours after
Secondary Outcome Measure Information:
Title
Airway response to inhaled methacholine
Description
delta log methacholine PC20 (provocative concentration of methacholine causing a 20% decrease in the forced expiratory volume in one second)
Time Frame
day before allergen inhalation challenge and 8 hours after allergen inhalation challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Cockcroft, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N0W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
journal publication
Citations:
PubMed Identifier
27222654
Citation
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.
Results Reference
derived

Learn more about this trial

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

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