Evaluation of the efficacy and safety of QMF149 vs Mometasone in patients with asthma

• Register: EUCTR
• Last refreshed on: 17 January 2022
• Main ID: EUCTR2015-002529-21-LV
• Date of registration: 14/10/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Evaluation of the efficacy and safety of QMF149 vs Mometasone in patients with asthma
• Scientific title: 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
• Date of first enrolment: 23/12/2015
• Target sample size: 2800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002529-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: yes; Other trial design description: triple-dummy; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Bulgaria, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Germany, Guatemala, Hungary, India, Ireland, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, United Kingdom

Contacts

• Name: Monica Couto
• Affiliation: Novartis Pharma Services AG

• Name: Monica Couto
• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients with a diagnosis of asthma, (GINA 2015 = step 3) for a period of at least 1 year prior to Visit 1
(Screening) 2. Patients who have used medium or high dose ICS (please refer to Appendix 11 for guidance) or low dose of LABA/ICS combinations for asthma for at least 1 year and at stable doses for at least 1 month prior to Visit 1
3. Patients must be symptomatic at screening despite treatment with mid or high stable doses of ICS and/or combinations of low dose ICS with longacting beta adrenergic agent. 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 (GINA 2015 step= 3) 4. Pre-bronchodilator = 50% FEV1 of < 80% of the predicted normal value for the patient after withholding bronchodilators (see Table 5-2) at both Visit 101 and 102. • 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, LAMA for = 7 days, theophylline o.d. for = 24 hours, theophylline b.i.d. for = 12 hours. • A onetime re-testing is allowed. Re-assessment of percentage predicted FEV1 should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before randomization. Spacer devices are not permitted during reversibility testing. * ICS should be continued. 5. 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: - Patients may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 1 year prior to Visit - Reversibility may be repeated once
- 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: 280
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion criteria:
Exclusion Criteria: • 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 according to the definition in Section 6.4.6 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 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Asthma
MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: Indacaterol acetate / mometasone furoate
Product Code: QMF149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: INDACATEROL ACETATE
Other descriptive name: INDACATEROL ACETATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: MOMETASONE FUROATE
Current Sponsor code: MF
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Product Name: Indacaterol acetate/Mometasone furoate
Product Code: QMF149
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: INDACATEROL ACETATE
Other descriptive name: INDACATEROL ACETATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: MOMETASONE FUROATE
Current Sponsor code: MF
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 320-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Trade Name: Asmanex Twisthaler
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: MOMETASONE FUROATE
Current Sponsor code: MF
Other descriptive name: MOMETASONE FUROATE
Concentration unit: µg microgram(s)
Concentration type: up to
Concentration number: 400-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use

Trade Name: Seretide
Product Name: Salmeterol xinafoate/fluticasone delivered via Diskus® (also known as Accuhaler®)
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: SALMETEROL XINAFOATE
CAS Number: 94749-08-3
Concentration unit: µg mic

Primary Outcome(s)

Primary end point(s): Comparison between QMF149 and Mometasone furoate in terms of FEV1.

Secondary Objective: To compare QMF149 150/160µg o.d. to MF 400µg o.d or QMF149 150/320µg o.d. to MF 800 µg (delivered as 400 µg b.i.d.)in terms of:
- Through FEV1 at week 52
- Pre-dose FEV1 at week 4 and 12
- FEV1, FVC and FEF over 52 weeks of treatment.
- PEF over 26 and 52 weeks
- ACQ-7 at week 4, 12, 26 and 52 weeks
- Percentage patients with MID of ACQ>=0,5 at week 26 and 52
- daily e-diary over 52 weeks
-rescue medication use over 26 and 52 weeks
- asthma exacerbation over 52 weeks
- % rescue medication free days over 26 and 52 weeks
-quality of life assessed by AQLQ-S 12 at 52 weeks
- incidence of composite endpoint of serious asthma outcomes
- Adverse event, vital signs, ECG and laboratory analysis

To compare QMF149 150/320µg with salmeterol xinafoate /fluticasone propionate 50/500µg for all the listed secondary endpoints above as well as through FEV 1 at week 26:

Main Objective: To demonstrate the superiority of either QMF149 150/160 µg delivered via Concept1 o.d. (in the evening) to MF 400 µg o.d (in the evening) delivered via Twisthaler® or QMF149 150/320 µg delivered via Concept1 o.d. (in the evening) to MF 800 µg delivered via Twisthaler® (delivered as 400 µg b.i.d.) in terms of FEV1 at 26 weeks.

Timepoint(s) of evaluation of this end point: 26 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 26 weeks

Secondary end point(s): Comparison between QMF149 and Mometasone furoate in terms of ACQ-7

Secondary ID(s)

CQVM149B2301

2015-002529-21-GB

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date: 28/10/2015
Contact:

Results

• Results available: Yes
• Date Posted: 05/01/2020
• Date Completed: 28/06/2019
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002529-21/results