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Completed

NCT Number: NCT02327234

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

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

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Key information

Conditions

Atopic Asthma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N0W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

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

Other names: Advil

Placebo

Drug

lactose filled 00 capsules to match appearance of ibuprofen intervention

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 30, 2014
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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