Efficacy and safety of QMF149 vs. salmeterol xinafoate/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2012-001172-12-BG
• Date of registration: 26/10/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Efficacy and safety of QMF149 vs. salmeterol xinafoate/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)
• Scientific title: A randomized, double-blind, 12-week treatment, parallel-group study to evaluate the efficacy and safety of QMF149 (150 µg/160 µg o.d.) compared with salmeterol xinafoate/fluticasone propionate (50 µg/500 µg b.i.d.) in patients with chronic obstructive pulmonary disease (COPD)
• Date of first enrolment: 08/01/2013
• Target sample size: 576
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001172-12
• 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: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Australia, Belgium, Bulgaria, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Israel, Malaysia, Netherlands, Poland, Romania, Singapore, South Africa, Spain, Sweden, Thailand, Turkey, Vietnam

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients with moderate to very severe COPD (GOLD 2 to GOLD 4)
according to the 2011 GOLD Guidelines
2. Patients with a post-bronchodilator FEV1 < 70% of the predicted
normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit
101).
3. Current or ex-smokers who have a smoking history of at least 10 pack
years (defined as the number of packs of 20 cigarettes smoked per day
multiplied by number of years the patient smoked. e.g.10 pack years = 1
pack /day x 10 yrs, or
½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who
has not smoked for = 6 months at screening.
*Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 576
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion criteria:
1. Patients who have had a COPD exacerbation that required treatment
with antibiotics and/or oral corticosteroids and/or hospitalization in the
6 weeks prior to screening (Visit 1).
2. Patients who develop a COPD exacerbation between screening (Visit
1) and treatment (Visit 201) will not be eligible but will be permitted to
be re-screened after a minimum of 6 weeks after the resolution of the
COPD exacerbation.
3. Patients who have had a respiratory tract infection within 4 weeks
prior to screening Visit 1.
4. Patients who develop a respiratory tract infection between screening
(Visit 1) and treatment (Visit 201) will not be eligible, but will be
permitted to be rescreened 4 weeks after the resolution of the
respiratory tract infection.
5. Patients requiring long term oxygen therapy prescribed for >12 hours
per day.
6. Patients with, a) any history of asthma or, b) onset of respiratory
symptoms prior to age 40 years.
*Other protocol-defined exclusion criteria may apply


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

Health Condition(s) or Problem(s) studied

Chronic obstructive pulmonary disease (COPD)
MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855

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
CAS Number: 1000160-96-2
Current Sponsor code: QAB149
Other descriptive name: indacaterol acetate
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 150-
INN or Proposed INN: mometasone furoate
CAS Number: 83919-23-7
Current Sponsor code: MF
Other descriptive name: MOMETASONE FUROATE
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

Trade Name: Seretide Discus (salmeterol xinafoate/fluticasone propionate) 50/500 µg b.i.d
Product Name: Salmeterol xinafoate/fluticasone delivered via Accuhaler®
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: fluticasone propionate
CAS Number: 80474-14-2
Other descriptive name: FLUTICASONE PROPIONATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
INN or Proposed INN: salmeterol xinafoate
CAS Number: 94749-08-3
Other descriptive name: salmeterol
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

Secondary Objective: To evaluate the efficacy of QMF149 compared with salmeterol
xinafoate/fluticasone propionate in terms pulmonary function, Transitional Dyspnoea Index (TDI) focal score, St George’s Respiratory Questionnaire (SGRQ) and Rescue medication usage.
To evaluate the safety and tolerability of QMF149 and salmeterol xinafoate/fluticasone propionate during 12 weeks of treatment.
To compare the efficacy of QMF149 with salmeterol xinafoate/fluticasone propionate in terms of the following exacerbation-related parameters.
To evaluate the effect of QMF149 compared with salmeterol xinafoate/fluticasone propionate in terms of obstructive sleep apnoea (OSA) by using Medical Outcome Study (MOS) sleep scale after 4 and 12 weeks of treatment.
To evaluate the effect of QMF149 compared with salmeterol xinafoate/fluticasone propionate in terms of chronic systemic inflammatory syndrome by using inflammatory parameters after 12 weeks of treatment.

Main Objective: The purpose of this study is to explore the efficacy of QMF149 (150/160 µg o.d.) delivered via Concept1 device compared with salmeterol xinafoate/fluticasone propionate (50/500 µg b.i.d.) delivered via Accuhaler® in patients with chronic obstructive pulmonary disease (COPD).

Primary end point(s): Trough Forced Expiratory Volume in one second (FEV1).

Outcome Measure Description: Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.

Timepoint(s) of evaluation of this end point: over 12 weeks

Secondary Outcome(s)

Secondary end point(s): Trough FEV1.
FEV1 at each timepoint
FVC at each timepoint
FEV1 AUC (5 min-4 h), (5 min-24 h)
The usage of rescue medication (short acting ß2-agonist)
Peak FEV1.
Patient reported outcome measures: SGRQ (St. George’s Respiratory Questionnaire)
Patient reported outcome measures: TDI (Transitional Dyspnoea Index)
Patient reported outcome measures: COPD Assessment Test
Safety and tolerability.

Timepoint(s) of evaluation of this end point: over 12 weeks

Secondary ID(s)

2012-001172-12-HU

CQMF149F2202

Source(s) of Monetary Support

Novartis Pharma Services AG