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
Colorado Springs, Colorado 80907
386
mi
from
Colorado Springs, CO
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Altoona, Pennsylvania 16602
1056
mi
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Altoona, PA
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Asheville, North Carolina 28803
859
mi
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Asheville, NC
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Bangor, Maine 04401
1575
mi
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Bangor, ME
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Bellevue, Nebraska 68123
253
mi
from
Bellevue, NE
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Bellingham, Washington 98225
1445
mi
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Bellingham, WA
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Berazategui, Buenos Aires
5616
mi
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Berazategui,
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Birmingham, Alabama 35209
685
mi
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Birmingham, AL
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Columbia, Maryland 21044
1134
mi
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Columbia, MD
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Columbus, Ohio 43205
812
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Columbus, OH
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Dallas, Texas 75216
353
mi
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Dallas, TX
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Denver, Colorado 80262
407
mi
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Denver, CO
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East Providence, Rhode Island 02914
1426
mi
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East Providence, RI
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Edmond, Oklahoma 73003
145
mi
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Edmond, OK
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Encinitas, California 92024
1141
mi
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Encinitas, CA
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Flagstaff, Arizona 86001
787
mi
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Flagstaff, AZ
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Fort Worth, Texas 76104
348
mi
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Fort Worth, TX
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Gastonia, North Carolina 28054
940
mi
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Gastonia, NC
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Grove City, Ohio 43123
805
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Grove City, OH
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La Vista, Nebraska 68128
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La Vista, NE
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Louisville, Kentucky 40202
656
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Louisville, KY
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Marietta, Georgia 30060
788
mi
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Marietta, GA
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Marion, Ohio 43302
810
mi
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Marion, OH
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McKinney, Texas 75069
324
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McKinney, TX
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Medford, Oregon 97504
1357
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Medford, OR
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Miami, Florida 33136
1320
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Miami, FL
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Miami Gardens, Florida 33169
1312
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Miami Gardens, FL
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Missoula, Montana 59808
1036
mi
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Missoula, MT
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Monroe, North Carolina 28112
978
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Monroe, NC
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Newport Beach, California 92663
1161
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Newport Beach, CA
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Omaha, Nebraska 68144
257
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Omaha, NE
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Orange, California 92868
1153
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Overland Park, Kansas 66210
190
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Overland Park, KS
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Pittsburgh, Pennsylvania 15224
974
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Plano, Texas 75024
327
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Plano, TX
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Richmond, Virginia 23249
1111
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Richmond, VA
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San Diego, California 92123
1138
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San Diego, CA
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Spokane, Washington 99202
1201
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Spokane, WA
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Stockton, California 95204
1278
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Tamarac, Florida 33321
1298
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Tamarac, FL
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Waldorf, Maryland 20602
1135
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Walnut Creek, California 94598
1319
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Westminster, California 92683
1162
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Winter Park, Florida 32789
1140
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Ypsilanti, Michigan 48197
812
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Ypsilanti, MI
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Zachary, Louisiana 70791
620
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Zachary, LA
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