Evaluation of the efficacy and safety of QMF149 vs Mometasone in patients with asthma
- Conditions
- AsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-002529-21-HR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2216
-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
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- 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 or use of nicotine inhalers such as ecigarettes
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 rescreened
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 supportive documentation
-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 adhoc 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 within 3 months prior to visit 101
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method