A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 75
Updated:3/16/2019
Start Date:December 29, 2015
End Date:July 25, 2019
Contact:Novartis Pharmaceuticals
Phone:1-888-669-6682

Use our guide to learn which trials are right for you!

The purpose of the trial is to evaluate the efficacy and safety of two different doses of
QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses
(MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic
patients as determined by pulmonary function testing, and effects on asthma control


Inclusion Criteria:

- Patients with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1
(Screening)

- Patients who have used medium or high dose ICS or low dose of LABA/ICS combinations
for asthma for at least 3 months and at stable doses for at least 1 month prior to
Visit 1

- Patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to
double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS

- Pre-bronchodilator ≥ 50% FEV1 of < 85 % of the predicted normal value for the patient
after withholding bronchodilators at both Visit 101 and 102, according to ATS/ERS
criteria.

- Withholding period of bronchodilators prior to spirometry: SABA for ≥ 6 hours and FDC
or free combinations of ICS/LABA for ≥ 48 hours, SAMA for ≥ 8 hours, xanthines >=07
days

- A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is
allowed at Visit 101 and at Visit 102.

Spacer devices are permitted for reversibility testing only.

-Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after
administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All
patients must perform a reversibility test at Visit 101

If reversibility is not demonstrated at Visit 101:

- Reversibility should be repeated once-

- Patients may be permitted to enter the study with historical evidence of reversibility
that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1

- Alternatively, patients may be permitted to enter the study with a historical positive
bronchoprovocation test that was performed within 2 years prior to Visit 1.

Exclusion Criteria:

- Patients who have smoked or inhaled tobacco products within the 6 month period prior
to Visit 1, or who have a smoking history of greater than 10 pack years. This includes
use of nicotine inhalers such as e-cigarettes at the time of Visit 1

- Patients who have had an asthma attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)

- Patients who have ever required intubation for a severe asthma attack/exacerbation.

- Patients who have a clinical condition which is likely to be worsened by ICS
administration (e.g. glaucoma, cataract and fragility fractures) who are according to
investigator's medical judgment at risk participating in the study).

- Patients who have had a respiratory tract infection or asthma worsening as determined
by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and
Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory
tract infection or asthma worsening.

- Patients with a history of chronic lung diseases other than asthma, including (but not
limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically
significant bronchiectasis and active tuberculosis.

- Patients with severe narcolepsy and/or insomnia.

- Patients who have a clinically significant ECG abnormality at Visit 101 (Start of Run-
In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG).
ECG evidence of myocardial infarction at Visit 101 (via central reader) should be
clinically assessed by the investigator with supportivedocumentation

- Patients with a history of hypersensitivity to lactose, any of the study drugs or to
similar drugs within the class including untoward reactions to sympathomimetic amines
or inhaled medication or any component thereof

- Patients who have not achieved an acceptable spirometry results at Visit 101 in
accordance with American Thoracic Society/European Respiratory Society (ATS/ERS)
criteria for acceptability and repeatability (rescreening allowed only once).

Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify
due to ATS/ERS criteria. If the patient fails the repeat assessment, the patient may be
rescreened once

- Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3
months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3
months prior to Visit 101 but expected to change throughout the course of the study.

- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during dosing of study treatment and for 30 days after stopping of study treatment.

- LAMA use within 3 months prior to Visit 101
We found this trial at
37
sites
North Dartmouth, Massachusetts 02747
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellevue, Nebraska 68123
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Birmingham, Alabama 35209
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Boerne, Texas 78006
?
mi
from
Boerne, TX
Click here to add this to my saved trials
Conyers, Georgia 30013
?
mi
from
Conyers, GA
Click here to add this to my saved trials
Cortland, New York 13045
?
mi
from
Cortland, NY
Click here to add this to my saved trials
Denver, Colorado 80262
?
mi
from
Denver, CO
Click here to add this to my saved trials
El Paso, Texas 79902
?
mi
from
El Paso, TX
Click here to add this to my saved trials
Greenfield, Wisconsin 53228
?
mi
from
Greenfield, WI
Click here to add this to my saved trials
Las Vegas, Nevada 89135
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Los Angeles, California 90095
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Medford, Oregon 97504
?
mi
from
Medford, OR
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Gardens, Florida 33169
?
mi
from
Miami Gardens, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New Orleans, Louisiana 70115
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
North Charleston, South Carolina 29420
?
mi
from
North Charleston, SC
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15224
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Plovdiv,
Click here to add this to my saved trials
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
?
mi
from
Portland, OR
Click here to add this to my saved trials
Riverside, California 92506
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Saint Louis, Missouri 63128
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Jose, California 95117
?
mi
from
San Jose, CA
Click here to add this to my saved trials
Sarasota, Florida 34239
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Skillman, New Jersey 08558
?
mi
from
Skillman, NJ
Click here to add this to my saved trials
Stockton, California 95204
?
mi
from
Stockton, CA
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tempe, Arizona 85283
?
mi
from
Tempe, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Waldorf, Maryland 20602
?
mi
from
Waldorf, MD
Click here to add this to my saved trials
Westminster, California 92683
?
mi
from
Westminster, CA
Click here to add this to my saved trials
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials