A multi-center, double-blind, placebo-controlled, parallel-group study to establishproof-of-concept and explore the efficacy of different doses of ACT-129968 in adultpatients with partly controlled asthma. - CONTRO

• Conditions: Allergic asthma; MedDRA version: 12.1Level: LLTClassification code 10001705Term: Allergic asthma

• Registration Number: EUCTR2009-011975-60-BG
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-24
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

- Males and females aged 18 to 65 years.
- Signed informed consent prior to any study-mandated procedure.
- Women of childbearing potential must use adequate contraception.
- Presenting with a diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines.
- Uncontrolled asthma while using only rescue medication as needed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant or lactating women.
- Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced
asthma.
- History of life-threatening asthma at any time, defined as an asthma episode that
required intubation and/or was associated with hypercapnia, respiratory arrest or
hypoxic seizures.
- Any asthma exacerbation requiring treatment with systemic corticosteroids within
the last 3 months.
- Any hospital admission for asthma within the last 6 months.
- Anti-IgE therapy (at any time).
- Ongoing or recent treatment with medication for allergic airway disease (either
prescribed or over-the-counter [OTC]) other than an inhaled beta2 agonist used
solely as reliever therapy on an ‘as-needed’ basis.
- Smoking within the last year, or life-time consumption of 10 pack-years e.g., 20 cigarettes/day for 10 years.
- Treatment with investigational asthma controller biological agents (recombinant
proteins or monoclonal antibodies) within 6 months prior to start of study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy ACT-129968 versus placebo on lung function.;Secondary Objective: - To explore the efficacy of different doses of ACT-129968 on lung function and symptoms of asthma.<br>- To assess the tolerability and safety of ACT-129968.<br>- To assess the pharmacokinetics (PK) of ACT-129968.;Primary end point(s): The primary endpoint is the change from baseline in FEV1 percentage of predicted (FEV1%oP) normal value.