Clinical trial NCT03138811: A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CSJ117 in Adult Subjects With Mild Atopic Asthma
Official title: A Randomized, Subject- and Investigator-blinded, Placebo-controlled, Paralleldesign, Bronchoprovocation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Inhaled CSJ117 in Adult Subjects With Mild Atopic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: asthma
allergen bronchoprovocation
pharmacodynamics
pharmacokinetics
safety
tolerability
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events and serious adverse events
timeFrame: 12 weeks
measure: Late asthmatic response as measured by the AUC for time adjusted percent decrease in FEV1
timeFrame: 12 weeks
measure: Late asthmatic response as measured by the maximum percentage decrease in FEV1
timeFrame: 12 weeks
Secondary outcomes:
measure: Early asthmatic response as measured by the time adjusted AUC percent decrease in FEV1
timeFrame: 6 weeks and 12 weeks
measure: Early asthmatic response as measured by the maximum percentage decrease in FEV1
timeFrame: 6 weeks and 12 weeks
measure: Early asthmatic response as measured by the minimum of the absolute in FEV1
timeFrame: 6 weeks and 12 weeks
measure: Late asthmatic response as measured by the time adjusted AUC in FEV1
timeFrame: 6 weeks
measure: Late asthmatic response as measured by the maximum percentage decrease in FEV1
timeFrame: 6 weeks
measure: Late asthmatic response as measured by the minimum absolute FEV1
timeFrame: 6 weeks and 12 weeks
measure: Measurement of CSJ117 serum concentration and calculation of Tmax
timeFrame: 12 weeks
measure: Measurement of CSJ117 serum concentration and calculation of Cmax
timeFrame: 12 weeks
measure: Measurement of CSJ117 serum concentration and calculation of AUCtau
timeFrame: 12 weeks
measure: Measurement of CSJ117 serum concentration and calculation of Ctrough)
timeFrame: 12 weeks
measure: Measurement of CSJ117 serum concentration and calculation of Racc
timeFrame: 12 weeks
measure: Measurement of CSJ117 serum concentration and calculation of Lambda_z
timeFrame: 12 weeks
measure: Measurement of CSJ117 serum concentration and calculation of T1/2
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Saskatchewan
country: Canada
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Grosshansdorf
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: