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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Setipiprant; Drug: Placebo

• Registration Number: NCT01225315
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-19
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Study Start: 2010-11-01
• Primary Completion: 2012-01-01
• Study Completion: 2012-02-01
• Disposition First Submitted: 2013-03-27
• Disposition First Submitted QC: 2013-03-27
• Disposition First Posted: 2013-04-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Setipiprant - Dose 1	Setipiprant	100 mg b.i.d.
Setipiprant - Dose 3	Setipiprant	1,000 mg b.i.d
Setipiprant - Dose 2	Setipiprant	500 mg b.i.d.
Matching Placebo	Placebo	Oral placebo

Primary Outcome Measures

Name	Time	Method
To demonstrate a change in forced expiratory volume while taking ACT-129968 versus placebo	Baseline to week 12

Secondary Outcome Measures

Name	Time	Method
Explore the efficacy of different doses of ACT-129968 on change in lung function and asthma control	Baseline to 12 weeks

Trial Locations

Locations (97)

Clinical Investigative Site # 6204; 🇺🇸 Los Angeles, California, United States

Clinical Investigative Site 6208; 🇺🇸 Los Angeles, California, United States

Clinical Investigative Site # 6219; 🇺🇸 Tallahassee, Florida, United States

Clinical Investigative Site 6213; 🇺🇸 Normal, Illinois, United States

Clinical Investigative Site # 6215; 🇺🇸 New Orleans, Louisiana, United States

Clinical Investigative Site # 6211; 🇺🇸 North Dartmouth, Massachusetts, United States

Clinical Investigative Site # 6209; 🇺🇸 Saint Louis, Missouri, United States

Clinical Investigative Site 6205; 🇺🇸 Bronx, New York, United States

Clinical Investigative Site # 6223; 🇺🇸 Winston-Salem, North Carolina, United States

Clinical Inverstigative Site #6201; 🇺🇸 Lake Oswego, Oregon, United States

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