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NCT Number: NCT03138811

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSJ117

Drug

inhaled once daily dose

placebo comparator

Drug

inhaled once daily dose

Primary outcomes

  1. Number of adverse events and serious adverse events

    Time frame: 12 weeks

    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.

  2. Late asthmatic response as measured by the AUC for time adjusted percent decrease in FEV1

    Time frame: 12 weeks

    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.

  3. Late asthmatic response as measured by the maximum percentage decrease in FEV1

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Early asthmatic response as measured by the time adjusted AUC percent decrease in FEV1

    Time frame: 6 weeks and 12 weeks

    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.

  2. Early asthmatic response as measured by the maximum percentage decrease in FEV1

    Time frame: 6 weeks and 12 weeks

    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.

  3. Early asthmatic response as measured by the minimum of the absolute in FEV1

    Time frame: 6 weeks and 12 weeks

    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.

  4. Late asthmatic response as measured by the time adjusted AUC in FEV1

    Time frame: 6 weeks

    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.

  5. Late asthmatic response as measured by the maximum percentage decrease in FEV1

    Time frame: 6 weeks

    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. Late asthmatic response as measured by the minimum absolute FEV1

    Time frame: 6 weeks and 12 weeks

    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.

  7. Measurement of CSJ117 serum concentration and calculation of Tmax

    Time frame: 12 weeks

    Tmax is the time to reach the maximum concentration after drug administration

  8. Measurement of CSJ117 serum concentration and calculation of Cmax

    Time frame: 12 weeks

    Cmax is the observed maximum plasma concentration following drug administration

  9. Measurement of CSJ117 serum concentration and calculation of AUCtau

    Time frame: 12 weeks

    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]

  10. Measurement of CSJ117 serum concentration and calculation of Ctrough)

    Time frame: 12 weeks

    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.

  11. Measurement of CSJ117 serum concentration and calculation of Racc

    Time frame: 12 weeks

    Racc is the accumulation ratio

  12. Measurement of CSJ117 serum concentration and calculation of Lambda_z

    Time frame: 12 weeks

    Lambda_z is the apparent elimination rate constant

  13. Measurement of CSJ117 serum concentration and calculation of T1/2

    Time frame: 12 weeks

    T1/2 is the terminal elimination half-life [time]

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 3, 2017
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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