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
Winter Park, Florida 32789
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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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Omaha, Nebraska 68144
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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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Ypsilanti, Michigan 48197
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Zachary, Louisiana 70791
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