Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the efficacy and safety of ACT-129968 in subjects with partly controlled asthma on reliever therapy only.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion; Idorsia Pharmaceuticals Ltd.
• Treatments: Albuterol

Criteria

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