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

Atopic Asthma Clinical Trial

Official title:

Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327234
• Other study ID #: Bio REB 14-283
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: April 19, 2016
• Start date: December 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atopic Asthma

Intervention

Drug:
• ibuprofen
2x 200mg ibuprofen, single dose, blinded in 00 capsules
• Placebo
lactose filled 00 capsules to match appearance of ibuprofen intervention

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	at time of allergen inhalation challenge and for 7 hours after	No
Secondary	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)	day before allergen inhalation challenge and 8 hours after allergen inhalation challenge	No