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
Portland, Oregon 97213
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Bronx, New York 10461
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Bronx, NY
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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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Fort Worth, TX
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Glebe,
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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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Knoxville, TN
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Lake Oswego, Oregon 97035
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Lake Oswego, OR
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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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Nashville, TN
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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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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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Spartanburg, SC
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Tallahassee, Florida 32308
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Tallahassee, FL
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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