Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:4/6/2019
Start Date:March 21, 2017
End Date:November 22, 2022
Contact:Novartis Pharmaceuticals
Email:trialandresults.registries@novartis.com
Phone:1-888-669-6682

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A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.

This study is a 2-treatment period, randomized, multicenter parallel-group study. The overall
purpose of this study is to provide long- term safety data for fevipiprant (QAW039) (Dose 1
and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA)
steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with
moderate-to- severe asthma.


Inclusion Criteria:

Patients completing a prior Phase 3 study of QAW039:

- Informed consent and assent (if applicable).

- Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of
QAW039.

- Patient is able to safely continue into the study as judged by the investigator.

Patients who have not previously participated in a study of QAW039:

- Written informed consent.

- A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.

- Evidence of airway reversibility or airway hyper- reactivity.

- FEV1 of ≤85% of the predicted normal value.

- An ACQ score ≥1.5 prior to entering the study.

Exclusion Criteria:

Patients completing a prior phase 3 study of QAW039:

- Pregnant or nursing (lactating) women.

- Women of child-bearing potential unless they are using basic methods of contraception
during dosing of study drug

- Patients who did not complete the Treatment Period on blinded study drug of the prior
QAW039 study they participated in.

- Inability to comply with all study requirements.

- Patient who experienced a serious and drug-related AE in the prior QAW039 study they
participated in.

Patients who have not previously participated in a study of QAW039:

- Use of other investigational drugs within 5 half-lives of study entry, or within 30
days, whichever is longer.

- Subjects who have participated in another trial of QAW039 (i.e.-the patient was
randomized in another study).

- A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).

- History of malignancy with the exception of local basal cell carcinoma of the skin

- Pregnant or nursing (lactating) women.

- Serious co-morbidities.

- Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of
pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses
as well as other statins will be permitted during the study.
We found this trial at
46
sites
Omaha, Nebraska 68144
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Altoona, Pennsylvania 16602
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Asheville, North Carolina 28803
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Bangor, Maine 04401
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Bellevue, Nebraska 68123
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Bellingham, Washington 98225
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Berazategui, Buenos Aires
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Birmingham, Alabama 35209
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Colorado Springs, Colorado 80907
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Columbia, Maryland 21044
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Columbus, Ohio 43205
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Dallas, Texas 75216
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Denver, Colorado 80262
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East Providence, Rhode Island 02914
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Edmond, Oklahoma 73003
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Encinitas, California 92024
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Flagstaff, Arizona 86001
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Fort Worth, Texas 76104
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Gastonia, North Carolina 28054
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Grove City, Ohio 43123
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La Vista, Nebraska 68128
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Louisville, Kentucky 40202
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Marietta, Georgia 30060
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Marion, Ohio 43302
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McKinney, Texas 75069
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Medford, Oregon 97504
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Miami, Florida 33136
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Miami Gardens, Florida 33169
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Missoula, Montana 59808
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Monroe, North Carolina 28112
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Newport Beach, California 92663
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Orange, California 92868
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Overland Park, Kansas 66210
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Pittsburgh, Pennsylvania 15224
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Plano, Texas 75024
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Richmond, Virginia 23249
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San Diego, California 92123
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Spokane, Washington 99202
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Stockton, California 95204
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Tamarac, Florida 33321
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Waldorf, Maryland 20602
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Walnut Creek, California 94598
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Westminster, California 92683
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Winter Park, Florida 32789
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Ypsilanti, Michigan 48197
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Zachary, Louisiana 70791
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