Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 August 2017 |
Main ID: |
EUCTR2012-001172-12-BE |
Date of registration:
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05/11/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and safety of QMF149 vs. salmeterol xinafoate/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)
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Scientific title:
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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:
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26/11/2012 |
Target sample size:
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576 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001172-12 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Bulgaria
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Denmark
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Finland
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Germany
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Greece
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Hong Kong
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Hungary
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India
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Israel
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Malaysia
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Netherlands
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Poland
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Romania
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Singapore
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South Africa
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Spain
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Sweden
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Thailand
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Turkey
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Vietnam
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Contacts
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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+41613241111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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+41613241111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Chronic obstructive pulmonary disease (COPD) MedDRA version: 14.1
Level: LLT
Classification code 10010952
Term: COPD
System Organ Class: 100000004855
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Intervention(s)
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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 (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
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Primary Outcome(s)
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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.
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Timepoint(s) of evaluation of this end point: over 12 weeks
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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).
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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.
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Secondary Outcome(s)
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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.
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Timepoint(s) of evaluation of this end point: over 12 weeks
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Secondary ID(s)
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CQMF149F2202
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2012-001172-12-HU
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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