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

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ClinicalTrials.gov Identifier: NCT02327234
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Don Cockcroft, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Atopic Asthma Drug: ibuprofen Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process
Study Start Date : December 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Ibuprofen
400mg (2X200mg) ibuprofen single dose once
Drug: ibuprofen
2x 200mg ibuprofen, single dose, blinded in 00 capsules
Other Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327234


Locations
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Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N0W8
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Don Cockcroft, MD University of Saskatchewan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Don Cockcroft, Professor, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02327234     History of Changes
Other Study ID Numbers: Bio REB 14-283
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: journal publication
Additional relevant MeSH terms:
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Ibuprofen
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action