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

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01225315

Run by

Idorsia Pharmaceuticals Ltd.

People needed

438

Starts

2010-11-01

Expected to finish

2012-02-01

Last updated by the study team

2018-07-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — St Louis, Missouri, United States
• Clinical Investigative Site 6205 — The Bronx, New York, United States
• Clinical Investigative Site # 6223 — Winston-Salem, North Carolina, United States
• Clinical Inverstigative Site #6201 — Lake Oswego, Oregon, United States
• Clinical Investigative Site # 6207 — Medford, Oregon, United States
• Clinical Investigative Site # 6214 — Portland, Oregon, United States
• Clinical Investigative Site 6203 — Philadelphia, Pennsylvania, United States
• Clinical Investigative Site # 6228 — Greenville, South Carolina, United States
• Clinical Investigative Site 6230 — Spartanburg, South Carolina, United States
• Clinical Investigative Site 6202 — Knoxville, Tennessee, United States
• Clinical Investigative Site 6226 — Nashville, Tennessee, United States
• Clinical Investigative Site # 6220 — El Paso, Texas, United States
• Clinical Investigative Site # 6225 — Fort Worth, Texas, United States
• Clinical Investigative Site # 6222 — San Antonio, Texas, United States
• Clinical Investigative Site 6229 — San Antonio, Texas, United States
• Clinical Investigative Site # 6217 — Madison, Wisconsin, United States
• Clinical Investigative Site 5002 — Glebe, Australia
• Clinical Investigative Site 5003 — Nedlands, Australia
• Clinical Investigative Site 5001 — Sherwood, Australia
• Clinical Investigative Site # 6204 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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