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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Setipiprant; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225315

AC-060A202

Details and patient eligibility

About

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

Enrollment: 438 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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438 participants in 4 patient groups, including a placebo group

Setipiprant - Dose 1

Experimental group

Description:

100 mg b.i.d.

Treatment:

Drug: Setipiprant

Setipiprant - Dose 2

Experimental group

Description:

500 mg b.i.d.

Treatment:

Drug: Setipiprant

Setipiprant - Dose 3

Experimental group

Description:

1,000 mg b.i.d

Treatment:

Drug: Setipiprant

Matching Placebo

Placebo Comparator group

Description:

Oral placebo

Treatment:

Drug: Placebo