The purpose of the trial is to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 *g and QVM149 150/50/160 *g via Concept1) over two respective QMF149 doses (QMF149 150/160 *g and QMF149 150/320 *g via Concept1 in…
ID
Source
Brief title
Condition
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to demonstrate superiority of either
QVM149 150/50/80 *g o.d. to QMF149 150/160 *g o.d. or QVM149 150/50/160 *g o.d.
to QMF149 150/320 *g o.d. all delivered via Concept1 in terms of trough FEV1
after 26 weeks of treatment in patients with asthma.
Secondary outcome
The key secondary objective is to demonstrate the superiority of either QVM149
150/50/80 *g o.d. to QMF149 150/160 *g o.d. or QVM149 150/50/160 *g o.d. to
QMF149 150/320 *g o.d., all delivered via Concept1, in terms of ACQ-7 after 26
and 52 weeks of treatment in patients with asthma.
Background summary
Asthma is a chronic inflammatory disorder of the airways associated with
airways hyper responsiveness that leads to recurrent episodes of wheezing,
breathlessness, chest tightness, and coughing, particularly at night or in the
early morning. These episodes are usually
associated with widespread but variable airflow obstruction within the lung
that is often reversible either spontaneously or with treatment.
Despite existing therapies there is still significant unmet medical needs in
asthma, with an estimated 300 million people affected worldwide. The Global
Burden of Asthma Report estimates that 15 million disability*adjusted life
years (DALYs) are lost annually due to asthma, representing 1% of the total
global burden. Annual worldwide deaths have been estimated at 250,000 (Beasley
R, 2004).
Study objective
The purpose of the trial is to evaluate the efficacy and safety of two
different doses of QVM149 (QVM149 150/50/80 *g and QVM149 150/50/160 *g via
Concept1) over two respective QMF149 doses (QMF149 150/160 *g and QMF149
150/320 *g via Concept1 in poorly controlled asthmatics as determined by
pulmonary function testing and effects on asthma control. The primary objective
of this study is to demonstrate superiority of either QVM149 150/50/80 *g o.d.
to QMF149 150/160 *g o.d. or QVM149 150/50/160 *g o.d. to QMF149 150/320 *g
o.d. all delivered via Concept1 in terms of trough FEV1 after 26 weeks of
treatment in patients with asthma.
Study design
52 weeks multi-center, randomized, double-blind, double-dummy, parallel-group,
active controlled study.
Intervention
The Investigational treatments are as follows:
- QVM149 (indacaterol acetate/ glycopyrronium bromide/MF)
150/50/80 *g o.d. delivered as powder in capsules via Concept1
-QVM149 (indacaterol acetate/glycopyrronium bromide/MF)
150/50/160 *g o.d. delivered as powder in capsules viaConcept1
The Comparative treatments are:
- QMF149 (indacaterol acetate/MF) 150/160 *g o.d. delivered as
powder in capsules via Concept1
- QMF149 (indacaterol acetate/MF) 150/320 *g o.d. delivered as
powder in capsules via Concept1
- salmeterol xinafoate/fluticasone propionate 50/500 *g b.i.d.
delivered as powder via Accuhaler®
In addition the following placebo will be provided to enable the
double-dummy design of the study:
- Placebo delivered as powder in capsules via Concept1
Placebo delivered as powder via Accuhaler®
Study burden and risks
Potential burden and risk for participants includes potential side effects of
study medication, time investment and additional tests and examinations.See
protocol, Investigator's Brochures, SmPCs and ABR-Form for additional
information on risk and benefits.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
1. Male and female adult patient * 18 years old and * 75 years.
2. Written informed consent must be obtained before any study-related assessment is
performed.
3. Patients with a diagnosis of asthma, (GINA 2015 * step 4) for a period of at least 1 year
prior to Visit 1 (Screening).
4. Patients who have used medium or high dose ICS/LABA combinations (protocol Appendix 10) for asthma for at least 3 months and at stable medium or high doses of ICS/LABA for at least 1 month prior to Visit 1.
5. Patients must be symptomatic at screening despite treatment with mid or high stable doses
of ICS/LABA. Patients with ACQ-7 score * 1.5 at Visit 101 and at Visit 102 (before randomization) (GINA 2015* step 4). In case that the spiromety is repeated. ACQ-7 should be repeaded as well.
6. Patients with documented history of at least one asthma exacerbation which required
medical care from a physician, ER visit (or local equivalent structure) or hospitalization in
the 12 months prior to Visit 1 and required systemic corticosteroid treatment.
Previous asthma exacerbation in this context is based on patient*s recall of unplanned need
for medical care at any primary care physician, pulmonologist, emergency room or hospital and treatment with systemic corticosteroids due to asthma exacerbation. Investigator must use appropriate means to ensure the accuracy of the patient's exacerbation history (e.g. Patient history at Visit 1 documentend in source notes, pharmacy recored, hospital records, or chart records are acceptable)
7. Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient according to ATS/ERS guidelines after withholding bronchodilators (protocol Table 5-2) at both visits 101 and 102.
8. Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes
after administration of 400 *g salbutamol/360 *g albuterol (or equivalent dose) at Visit 101.
Exclusion criteria
1. 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 (Note:1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or * pack/day x 20 yrs.) This includes inhalers such as e-cigarettes at time of Visit 1.
2. Patients who have had an asthma attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). If patients
experience an asthma attack/exacerbation requiring systemic steroids or hospitalization or
emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks
after recovery from the exacerbation.
3. Patients who have ever required intubation for a severe asthma attack/exacerbation.
4. 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.
5. Patients treated with a LAMA for asthma within 3 months prior Visit 1 (Screening).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2015-002899-25-NL |
ClinicalTrials.gov | NCT02571777 |
CCMO | NL55316.075.15 |