Efficacy and safety of low dose QMF149 (150/80 microgram) compared with MF Twisthaler® 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
- EUCTR2016-000472-22-SE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
- Patients with a documented diagnosis of asthma for a period of at least
3 months prior to Screening Visit
- Patients who have used low dose ICS , with or without controller (ie,
LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1
month prior to Screening Visit
-Adult patients who are symptomatic despite treatment with existing
therapy.
Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102
(inadequately
controlled).
- Adolescent patients : If taking only ICS (without LABA) and are
symptomatic at screening despite treatment with low doses of ICS.
These patients must have ACQ-7 score = 1.5 at Visit 101 and at Visit 102
. If taking ICS (low dose)/ LABA, and have ACQ-7 score =1 and <1.5 at
Visit 101: they must have ACQ-7 score=1.5 at Visit 102 ( prior to
randomization).
- Pre-bronchodilator FEV1= 60 % and < 90 % of the predicted normal
value for the patient after withholding bronchodilators at both Visits 101 and 102
- Patients who demonstrate an increase in FEV1 of 12% and = 200 mL
within 30 minutes after administration of 400 microgram
salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 665
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
- Patients who have smoked or inhaled tobacco products (including
electronic cigarettes) within the 6 month period prior to Visit 1, or who
have a smoking history of greater than or equal to 10 pack year.
- Patients who have had an asthma attack/exacerbation requiring
systemic steroids or hospitalization (> 24 hours) or emergency room
visit (= 24 hours) as follows:
For adults: within 6 weeks of Screening Visit. If patients experience an
asthma attack/exacerbation requiring systemic steroids or emergency
room visit between Visit 1 and Visit 102 they may be re-screened 6
weeks after recovery
from the exacerbation
For adolescents: Severe asthma attack/exacerbation requiring systemic
corticosteroid in the last 6 months or hospitalization (> 24 hours) due
to severe asthma attack/exacerbation requiring systemic corticosteroids
in the last 6 months or emergency room visit (=24 hours) due to severe
asthma attack/exacerbation requiring systemic corticosteroids within
the last 6 months..
- Patients who ever required intubation for a severe asthma
attack/exacerbation
- Patients with a clinical condition (eg. glaucoma, cataract and fragility
fractures) which may be worsened by ICS administration (according to
investigator's medical judgment )
- Patients who have had a respiratory tract infection or asthma
worsening within 4 weeks prior to Screening Visit or between Visit 1and
Visit 102. Patients may be re-screened 4 weeks after recovery from their
respiratory tract infection or
asthma worsening.
- Patients with any chronic conditions affecting the upper respiratory
tract (eg.chronic sinusitis) which in the opinion of the investigator may
interfere with the study.
- 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 Type I diabetes or uncontrolled Type II diabetes.
- Patients with narcolepsy and/or insomnia.
- 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.
- Patients with diagnosed rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption or with known intolerance to lactose or milk products.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to demonstrate the superiority of QMF149<br>150/80 microgram o.d. (in the evening) delivered via Concept1 compared with<br>MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of<br>trough FEV1 after 12 weeks of treatment in adults and adolescents. ;Secondary Objective: The key secondary objective of this study is to demonstrate the superiority of QMF149<br>150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks<br>of treatment.;Primary end point(s): - To demonstrate the superiority of QMF149 150/80 microgram o.d. (in<br>the evening) delivered via Concept1 compared with MF 200 microgram<br>o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1<br>after 12 weeks of treatment in adults and adolescents.;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - ACQ-7 after 4 weeks of treatment and after 12 weeks of treatment<br>- Trough FEV1 at day<br>- Pre-dose FEV1 at week 4<br>- FVC over 12 weeks<br>- PEF over 4 and 12 weeks<br>- Percentage of patients with MID at week 12<br>- Daily e-diary over 12 weeks<br>- Rescue medication use over 12 weeks<br>- Percentage of rescue medication free days over 12 weeks<br>- Asthma exacerbation over 12 weeks<br>- Quality of life assessed by AQLQ-S 12<br>- Composite endpoint of serious asthma outcomes;Timepoint(s) of evaluation of this end point: Time points for each secondary endpoint is included in section E 5.2