A Bronchoprovocation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CSJ117 in Adult Subjects With Mild Atopic Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138811
• Other study ID #: CCSJ117X2201
• Secondary ID: 2016-004929-16
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2017
• Est. completion date: July 16, 2019

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CSJ117
inhaled once daily dose
• Placebo Comparator
inhaled once daily dose

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Hamilton	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Saskatchewan
Canada	Novartis Investigative Site	Vancouver
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Grosshansdorf
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Secondary	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.	6 weeks and 12 weeks
Secondary	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.	6 weeks and 12 weeks
Secondary	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.	6 weeks and 12 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks and 12 weeks
Secondary	Measurement of CSJ117 serum concentration and calculation of Tmax	Tmax is the time to reach the maximum concentration after drug administration	12 weeks
Secondary	Measurement of CSJ117 serum concentration and calculation of Cmax	Cmax is the observed maximum plasma concentration following drug administration	12 weeks
Secondary	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]	12 weeks
Secondary	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.	12 weeks
Secondary	Measurement of CSJ117 serum concentration and calculation of Racc	Racc is the accumulation ratio	12 weeks
Secondary	Measurement of CSJ117 serum concentration and calculation of Lambda_z	Lambda_z is the apparent elimination rate constant	12 weeks
Secondary	Measurement of CSJ117 serum concentration and calculation of T1/2	T1/2 is the terminal elimination half-life [time]	12 weeks

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com
•   Results for CCSJ117X2201 from the Novartis Clinical Trials Website