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Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215758
Recruitment Status : Completed
First Posted : July 12, 2017
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
A randomized, multicenter, double-blind, placebo- controlled parallel-group study to determine the efficacy and safety of QAW039, compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1 second (FEV1) at the end of 12 weeks of treatment.

Condition or disease Intervention/treatment Phase
Asthma Drug: QAW039 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 675 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: QAW039
QAW039 once daily
Drug: QAW039
QAW039 once daily

Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo once daily




Primary Outcome Measures :
  1. Pre-dose Forced Expiratory Volume in 1 second (FEV1) (L) [ Time Frame: Week 12 ]
    Change from baseline in pre- dose FEV1 [in liters].


Secondary Outcome Measures :
  1. Daytime asthma symptom score [ Time Frame: 12 weeks ]
    Change from baseline in daytime asthma symptom score.

  2. Short-acting beta agonist (SABA) taken per day [ Time Frame: 12 weeks ]
    Change from baseline in number of puffs of SABA taken per day.

  3. Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) score [ Time Frame: Week 12 ]
    Change from baseline in Asthma Quality of Life Questionnaire for 12 years and older (AQLQ+12) score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.
  • Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1 and the doses have been stable for at least 4 weeks prior to Visit 1.
  • FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18 years.
  • Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days of the placebo run- in period.
  • Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in period.
  • Demonstrated reversible airway obstruction.
  • Asthma control questionnaire (ACQ) score ≥ 1.5.

Exclusion Criteria:

  • Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
  • A resting QTcF (Fridericia) ≥450 msec (male) or

    ≥460 msec (female).

  • Pregnant or nursing (lactating) women.
  • Serious co-morbidities.
  • Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215758


Locations
Hide Hide 107 study locations
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United States, Arizona
Novartis Investigative Site
Flagstaff, Arizona, United States, 86001
Novartis Investigative Site
Phoenix, Arizona, United States, 85006
United States, California
Novartis Investigative Site
Huntington Beach, California, United States, 92647
Novartis Investigative Site
Long Beach, California, United States, 90808
Novartis Investigative Site
Los Angeles, California, United States, 90025
Novartis Investigative Site
Mission Viejo, California, United States, 92691
Novartis Investigative Site
Mountain View, California, United States, 94040
Novartis Investigative Site
Orange, California, United States, 92868
Novartis Investigative Site
Roseville, California, United States, 95661
Novartis Investigative Site
Walnut Creek, California, United States, 94598
United States, Colorado
Novartis Investigative Site
Denver, Colorado, United States, 80206
United States, Florida
Novartis Investigative Site
Tamarac, Florida, United States, 33321
Novartis Investigative Site
Winter Park, Florida, United States, 32789
United States, Georgia
Novartis Investigative Site
Albany, Georgia, United States, 31707
Novartis Investigative Site
Dacula, Georgia, United States, 30019
United States, Hawaii
Novartis Investigative Site
Honolulu, Hawaii, United States, 96814
Novartis Investigative Site
Lihue, Hawaii, United States, 96766
United States, Kansas
Novartis Investigative Site
Overland Park, Kansas, United States, 66210
United States, Kentucky
Novartis Investigative Site
Louisville, Kentucky, United States, 40215
United States, Missouri
Novartis Investigative Site
Columbia, Missouri, United States, 65203
Novartis Investigative Site
Rolla, Missouri, United States, 65401
United States, Montana
Novartis Investigative Site
Missoula, Montana, United States, 59808
United States, Nebraska
Novartis Investigative Site
Bellevue, Nebraska, United States, 68123
Novartis Investigative Site
La Vista, Nebraska, United States, 68128
United States, New Jersey
Novartis Investigative Site
Skillman, New Jersey, United States, 08558
United States, North Carolina
Novartis Investigative Site
Asheville, North Carolina, United States, 28801
Novartis Investigative Site
Gastonia, North Carolina, United States, 28054
Novartis Investigative Site
High Point, North Carolina, United States, 27262
United States, Ohio
Novartis Investigative Site
Cincinnati, Ohio, United States, 45231
United States, Oklahoma
Novartis Investigative Site
Edmond, Oklahoma, United States, 73034
United States, Oregon
Novartis Investigative Site
Eugene, Oregon, United States, 97401-4043
Novartis Investigative Site
Medford, Oregon, United States, 97504
Novartis Investigative Site
Portland, Oregon, United States, 97213
Novartis Investigative Site
Portland, Oregon, United States, 97220
United States, South Dakota
Novartis Investigative Site
Rapid City, South Dakota, United States, 57701
United States, Texas
Novartis Investigative Site
Boerne, Texas, United States, 78006
Novartis Investigative Site
Dallas, Texas, United States, 75231
Novartis Investigative Site
El Paso, Texas, United States, 79903
Novartis Investigative Site
Fort Worth, Texas, United States, 76109
Novartis Investigative Site
McKinney, Texas, United States, 75069
United States, Wisconsin
Novartis Investigative Site
Greenfield, Wisconsin, United States, 53228
Argentina
Novartis Investigative Site
Berazategui, Buenos Aires, Argentina, 1888
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1056ABJ
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1122AAK
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1425BEN
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1426ABP
Novartis Investigative Site
Lanus, Buenos Aires, Argentina, B8000XAV
Novartis Investigative Site
Mar del Plata, Buenos Aires, Argentina, 7600
Novartis Investigative Site
Santa Rosa, La Pampa, Argentina, 6300
Novartis Investigative Site
Buenos Aires, Nueve De Julio, Argentina, B6500BWQ
Novartis Investigative Site
Santa Fe, Rosario, Argentina, S2000DBS
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000BRH
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000JKR
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, 4000
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
Novartis Investigative Site
Buenos Aires, Argentina, C1012AAR
Novartis Investigative Site
Buenos Aires, Argentina, C1125ABE
Novartis Investigative Site
Cordoba, Argentina, X5003DCE
Novartis Investigative Site
Mendoza, Argentina, 5500
Novartis Investigative Site
Mendoza, Argentina, M5500CBA
Novartis Investigative Site
Salta, Argentina, 4000
Germany
Novartis Investigative Site
Peine, Niedersachsen, Germany, 31224
Novartis Investigative Site
Cottbus, Sachsen, Germany, 03050
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Bamberg, Germany, 96049
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Furstenwalde, Germany, 15517
Novartis Investigative Site
Gauting, Germany, 82131
Novartis Investigative Site
Leipzig, Germany, 04275
Novartis Investigative Site
Lubeck, Germany, 23552
Novartis Investigative Site
Prien A Chiemsee, Germany, 83209
Novartis Investigative Site
Rudersdorf, Germany, 15562
Novartis Investigative Site
Schleswig, Germany, 24837
Novartis Investigative Site
Schwerin, Germany, 19055
Novartis Investigative Site
Witten, Germany, 58452
Hungary
Novartis Investigative Site
Budaors, HUN, Hungary, 2040
Novartis Investigative Site
Ajka, Hungary, 8400
Novartis Investigative Site
Debrecen, Hungary, 4032
Novartis Investigative Site
Godollo, Hungary, 2100
Novartis Investigative Site
Szeged, Hungary, 6722
Mexico
Novartis Investigative Site
Culiacan, Sinaloa, Mexico, 80230
Novartis Investigative Site
Rio De Janeiro, Mexico, 06700
Philippines
Novartis Investigative Site
Lipa City, Batangas, Philippines, 4217
Novartis Investigative Site
Quezon City, Manila, Philippines, 1100
Novartis Investigative Site
Iloilo City, Philippines, 5000
Novartis Investigative Site
Manila, Philippines, 1000
Saudi Arabia
Novartis Investigative Site
Riyadh, SAU, Saudi Arabia, 11525
Novartis Investigative Site
Jeddah, Saudi Arabia, 21423
Slovakia
Novartis Investigative Site
Bardejov, Slovak Republic, Slovakia, 085 01
Novartis Investigative Site
Kezmarok, Slovakia, 060 01
Novartis Investigative Site
Michalovce, Slovakia, 071 01
Novartis Investigative Site
Poprad, Slovakia, 058 01
Novartis Investigative Site
Presov, Slovakia, 080 01
Novartis Investigative Site
Spisska Nova Ves, Slovakia, 052 01
Novartis Investigative Site
Zilina, Slovakia, 01207
South Africa
Novartis Investigative Site
Tygerberg, Cape Town, South Africa, 7505
Novartis Investigative Site
Cape Town, South Africa, 7500
Novartis Investigative Site
Chatsworth, South Africa, 4092
Novartis Investigative Site
Durban, South Africa, 4001
Novartis Investigative Site
Pretoria, South Africa, 0183
Turkey
Novartis Investigative Site
Istanbul, TUR, Turkey, 34098
Novartis Investigative Site
Adana, Turkey, 01330
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Istanbul, Turkey, 34020
Novartis Investigative Site
Mersin, Turkey, 33343
Novartis Investigative Site
Talas / Kayseri, Turkey, 38039
Novartis Investigative Site
Yenisehir/Izmir, Turkey, 35110
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03215758    
Other Study ID Numbers: CQAW039A2316
2017-001273-16 ( EudraCT Number )
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QAW039, uncontrolled asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs