Status:
COMPLETED
Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study-mandated procedure
- Males and females age 18 to 65 years
- Women of childbearing potential must use adequate contraception
- Presenting with a diagnosis of asthma according to GINA Guidelines
- Pre-bronchodilator forced expiratory volume in one second (FEV1) \< / = 85% of patient's predicted normal value
- Reversibility of airway obstruction of \> / = 12% and \> / = 200mL from pre-bronchodilator FEV1
- ACQ score \> / = 1.5
Exclusion
- History of life-threatening asthma
- Any asthma exacerbation requiring treatment with systemic corticosteroids within the last 3 months
- Ongoing or recent treatment with medication for allergic airway disease
- Smoking within the last year, or life-time consumption \> / = 10 pack-years (e.g., 20 cigarettes/day for 10 years)
- History of chronic pulmonary disease (other than asthma), such as chronic obstructive pulmonary disease (COPD), fibrosis, tuberculosis or sarcoidosis
- Pregnant or lactating women
- Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma
- Any hospital admission for asthma within the last 6 months
- Anti-IgE therapy at any time check/update interventions by explicitely writing the experimental drug dosage in the interventions description
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT01225315
Start Date
November 1 2010
End Date
February 1 2012
Last Update
July 9 2018
Active Locations (97)
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1
Clinical Investigative Site # 6204
Los Angeles, California, United States, 90025
2
Clinical Investigative Site 6208
Los Angeles, California, United States, 90095
3
Clinical Investigative Site # 6219
Tallahassee, Florida, United States, 32308
4
Clinical Investigative Site 6213
Normal, Illinois, United States, 61761