Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 7/11/2018 |
Start Date: | November 1, 2010 |
End Date: | February 1, 2012 |
A Multi-center, Double-blind, Placebo-controlled, Parallel-group Study to Establish Proof-of-concept and Explore the Efficacy of Different Doses of ACT-129968 in Adult Patients With Partly Controlled Asthma
This study will assess the efficacy and safety of ACT-129968 in subjects with partly
controlled asthma on reliever therapy only.
controlled asthma on reliever therapy only.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
21
sites
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