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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
inhaled once daily dose
inhaled once daily dose
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Saskatchewan, Saskatchewan, Canada
Novartis Investigative Site
Vancouver, Canada
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Großhansdorf, Germany
Novartis Investigative Site
Hanover, Germany
Novartis Investigative Site
Mainz, Germany
Number of adverse events and serious adverse events
An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that is given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug are classified as a treatment emergent adverse event.
Time frame: 12 weeks
Late asthmatic response as measured by the AUC for time adjusted percent decrease in FEV1
Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The AUC for time adjusted percent decrease in FEV1 will be compared between CSJ117 and placebo groups.
Time frame: 12 weeks
Late asthmatic response as measured by the maximum percentage decrease in FEV1
Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The maximum percentage decrease in FEV1 will be compared between CSJ117 and placebo groups.
Time frame: 12 weeks
Early asthmatic response as measured by the time adjusted AUC percent decrease in FEV1
Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The time adjusted AUC percent decrease will be compared between CSJ117 and placebo groups.
Time frame: 6 weeks and 12 weeks
Early asthmatic response as measured by the maximum percentage decrease in FEV1
Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The maximum percentage decrease will be compared between CSJ117 and placebo groups.
Time frame: 6 weeks and 12 weeks
Early asthmatic response as measured by the minimum of the absolute in FEV1
Early asthmatic response (EAR) is considered a ≥ 20% fall in FEV1 within the 2 hours after an allergen inhalation challenge. The minimum of the absolute in FEV1 will be compared between CSJ117 and placebo groups.
Time frame: 6 weeks and 12 weeks
Late asthmatic response as measured by the time adjusted AUC in FEV1
Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The time adjusted in FEV1 will be compared between CSJ117 and placebo groups.
Time frame: 6 weeks
Late asthmatic response as measured by the maximum percentage decrease in FEV1
Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The maximum percentage decrease in FEV1 will be compared between CSJ117 and placebo groups.
Time frame: 6 weeks
Late asthmatic response as measured by the minimum absolute FEV1
Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The minimum absolute in FEV1 will be compared between CSJ117 and placebo groups.
Time frame: 6 weeks and 12 weeks
Measurement of CSJ117 serum concentration and calculation of Tmax
Tmax is the time to reach the maximum concentration after drug administration
Time frame: 12 weeks
Measurement of CSJ117 serum concentration and calculation of Cmax
Cmax is the observed maximum plasma concentration following drug administration
Time frame: 12 weeks
Measurement of CSJ117 serum concentration and calculation of AUCtau
The area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau \[mass x time / volume\]
Time frame: 12 weeks
Measurement of CSJ117 serum concentration and calculation of Ctrough)
Ctrough is the observed serum (or plasma or blood) concentration that is just prior to the beginning of, or at the end of, a dosing interval.
Time frame: 12 weeks
Measurement of CSJ117 serum concentration and calculation of Racc
Racc is the accumulation ratio
Time frame: 12 weeks
Measurement of CSJ117 serum concentration and calculation of Lambda_z
Lambda\_z is the apparent elimination rate constant
Time frame: 12 weeks
Measurement of CSJ117 serum concentration and calculation of T1/2
T1/2 is the terminal elimination half-life \[time\]
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.