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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01225315
• Date of registration: 19/10/2010
• Prospective Registration: Yes
• Primary sponsor: Idorsia Pharmaceuticals Ltd.
• Public title: Clinical Study to Explore the Efficacy of ACT-129968 in Patients With Partly Controlled Asthma CONTROL
• Scientific title: 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
• Date of first enrolment: November 1, 2010
• Target sample size: 438
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01225315
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Australia, Bulgaria, Germany, Hungary, Israel, Poland, Russian Federation, Serbia, Singapore, South Africa, Sweden, Ukraine, United States

Contacts

• Name: Sara Mangialaio, MD
• Affiliation: Actelion

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Placebo

Drug: Setipiprant

Primary Outcome(s)

To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo [Time Frame: Baseline to week 12]

Secondary Outcome(s)

Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control [Time Frame: Baseline to 12 weeks]

Secondary ID(s)

AC-060A202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors