A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynam… (NCT03138811) | Clinical Trial Compass
CompletedPhase 1
A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CSJ117 in Adult Subjects With Mild Atopic Asthma
Canada28 participantsStarted 2017-12-18
Plain-language summary
This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled, parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two parts, Cohort 2a and 2b
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Diagnosis of stable mild atopic asthma, as defined by the American Thoracic Society/ European Respiratory Society statement, who exhibit an early and late asthmatic response to a common inhaled allergen during the screening allergen inhalation challenge.
* Throughout the screening period and at baseline, only infrequent use of inhaled short-acting beta2-agonists (less than or equal to twice weekly) to treat asthma and/or prophylactic use prior to exercise. Inhaled short-acting beta2-agonist must be withheld for 8 hours before spirometry.
Exclusion Criteria:
* Hospitalization or emergency room treatment for acute asthma in the 6 months prior to screening or during the screening period.
* Any worsening or exacerbation of asthma (e.g., an event requiring a change in treatment) in the six weeks before screening or during the screening period.
* A history of any clinically significant chronic pulmonary disease other than mild atopic asthma, including but not limited to COPD, interstitial lung disease or bronchiectasis
* Use of immunosuppressive medications or allergen-specific immunotherapy within 6 months prior to screening.
What they're measuring
1
Number of adverse events and serious adverse events
Timeframe: 12 weeks
2
Late asthmatic response as measured by the AUC for time adjusted percent decrease in FEV1
Timeframe: 12 weeks
3
Late asthmatic response as measured by the maximum percentage decrease in FEV1