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



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:7/11/2018
Start Date:November 1, 2010
End Date:February 1, 2012

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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

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


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
We found this trial at
21
sites
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Bronx, New York 10461
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El Paso, Texas 79903
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El Paso, TX
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Fort Worth, Texas 76132
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Greenville, South Carolina 29615
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Greenville, SC
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Knoxville, Tennessee 37909
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Lake Oswego, Oregon 97035
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Los Angeles, California 90025
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Los Angeles, CA
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Madison, Wisconsin 53792
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Madison, WI
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Medford, Oregon 97504
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Medford, OR
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Nashville, Tennessee 37208
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New Orleans, Louisiana 70112
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New Orleans, LA
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Normal, Illinois 61761
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Normal, IL
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North Dartmouth, Massachusetts 02747
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North Dartmouth, MA
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Portland, Oregon 97213
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Portland, OR
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Saint Louis, Missouri 63141
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Saint Louis, MO
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San Antonio, Texas 78229
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San Antonio, TX
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Spartanburg, South Carolina 29303
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Tallahassee, Florida 32308
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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