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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01636076




Registration number
NCT01636076
Ethics application status
Date submitted
5/07/2012
Date registered
10/07/2012
Date last updated
17/11/2014

Titles & IDs
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
Secondary ID [1] 0 0
2012-001172-12
Secondary ID [2] 0 0
CQMF149F2202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QMF149
Treatment: Drugs - Salmeterol

Experimental: QMF149 - QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device

Active comparator: Salmeterol xinafoate/fluticasone propionate - Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®


Treatment: Drugs: QMF149
delivered via Concept1 device

Treatment: Drugs: Salmeterol
delivered via Accuhaler®
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Trough FEV1 After First Dose and After 4 Weeks of Treatment
Timepoint [1] 0 0
Day 1 and Day 85
Secondary outcome [2] 0 0
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint
Timepoint [2] 0 0
Day 1 through day 85
Secondary outcome [3] 0 0
Forced Vital Capacity (FVC) at Each Timepoint
Timepoint [3] 0 0
Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85
Secondary outcome [4] 0 0
FEV1/FVC at Each Timepoint
Timepoint [4] 0 0
Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85
Secondary outcome [5] 0 0
FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h)
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
FEV1 AUC (5 Min-4 h),
Timepoint [6] 0 0
Day 1(Baseline), Day 28, Day 84
Secondary outcome [7] 0 0
Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min - 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)
Timepoint [7] 0 0
Day 28, Day 84
Secondary outcome [8] 0 0
The Usage of Rescue Medication (Short Acting ß2-agonist)
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
The Overall Change in Usage of Rescue Medication (Short Acting ß2-agonist) .
Timepoint [9] 0 0
Baseline to 12 weeks
Secondary outcome [10] 0 0
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)
Timepoint [10] 0 0
4 and 12 weeks
Secondary outcome [11] 0 0
Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit
Timepoint [11] 0 0
4 and 12 weeks
Secondary outcome [12] 0 0
Patient Reported Outcome Measures: COPD Assessment Test
Timepoint [12] 0 0
Baseline, 4 and 12 weeks
Secondary outcome [13] 0 0
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale
Timepoint [13] 0 0
Baseline, 4 and 12 weeks
Secondary outcome [14] 0 0
Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale
Timepoint [14] 0 0
Baseline, 4 and 12 weeks
Secondary outcome [15] 0 0
Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)
Timepoint [15] 0 0
12 weeks
Secondary outcome [16] 0 0
Time to First COPD Exacerbation
Timepoint [16] 0 0
12 weeks
Secondary outcome [17] 0 0
Annual Rate of COPD Exacerbations
Timepoint [17] 0 0
12 weeks
Secondary outcome [18] 0 0
Duration (in Days) of COPD Exacerbations
Timepoint [18] 0 0
12 weeks
Secondary outcome [19] 0 0
Percentage of Patients With at Least One Exacerbation up to Week 12
Timepoint [19] 0 0
12 weeks
Secondary outcome [20] 0 0
Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation
Timepoint [20] 0 0
12 weeks
Secondary outcome [21] 0 0
The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation
Timepoint [21] 0 0
12 weeks
Secondary outcome [22] 0 0
Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period
Timepoint [22] 0 0
12 weeks
Secondary outcome [23] 0 0
Plasma Cortisol Concentrations at Each Timepoint
Timepoint [23] 0 0
Day 1, Day 28, Day 84
Secondary outcome [24] 0 0
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint
Timepoint [24] 0 0
Day 1, 29, 84
Secondary outcome [25] 0 0
Pharmacokinetic Parameter: Cmax
Timepoint [25] 0 0
Day 28, 84
Secondary outcome [26] 0 0
Pharmacokinetic Parameter--Tmax
Timepoint [26] 0 0
Day 28, 84
Secondary outcome [27] 0 0
Pharmacokinetic Parameter--AUC0-t
Timepoint [27] 0 0
Day 28, 84

Eligibility
Key inclusion criteria
* Patients with moderate to very severe COPD (GOLD 2 to GOLD 4) according to the 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines
* Patients with a post-bronchodilator FEV1 < 70% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit 101).
* 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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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).
* 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.
* Patients who have had a respiratory tract infection within 4 weeks prior to screening Visit 1.
* 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 re-screened 4 weeks after the resolution of the respiratory tract infection.
* Patients requiring long term oxygen therapy prescribed for >12 hours per day.
* Patients with, a) any history of asthma or, b) onset of respiratory symptoms prior to age 40 years.

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
629
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Concord
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [3] 0 0
Novartis Investigative Site - New Lambton Heights
Recruitment hospital [4] 0 0
Novartis Investigative Site - Redcliffe
Recruitment hospital [5] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [6] 0 0
Novartis Investigative Site - Daw Park
Recruitment hospital [7] 0 0
Novartis Investigative Site - Woodville South
Recruitment hospital [8] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [9] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [10] 0 0
Novartis Investigative Site - Franston
Recruitment hospital [11] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
4020 - Redcliffe
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5041 - Daw Park
Recruitment postcode(s) [7] 0 0
5011 - Woodville South
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3199 - Franston
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Halen
Country [3] 0 0
Belgium
State/province [3] 0 0
Liege
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Pleven
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Russe
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Stara Zagora
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Varna
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Veliko Tarnovo
Country [10] 0 0
Denmark
State/province [10] 0 0
Copenhagen NV
Country [11] 0 0
Denmark
State/province [11] 0 0
Hellerup
Country [12] 0 0
Denmark
State/province [12] 0 0
Hvidovre
Country [13] 0 0
Denmark
State/province [13] 0 0
Odense C
Country [14] 0 0
Finland
State/province [14] 0 0
Pori
Country [15] 0 0
Finland
State/province [15] 0 0
Tampere
Country [16] 0 0
Finland
State/province [16] 0 0
Turku
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Donaustauf
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt
Country [20] 0 0
Germany
State/province [20] 0 0
Großhansdorf
Country [21] 0 0
Germany
State/province [21] 0 0
Hannover
Country [22] 0 0
Germany
State/province [22] 0 0
Lübeck
Country [23] 0 0
Germany
State/province [23] 0 0
Rüdersdorf
Country [24] 0 0
Germany
State/province [24] 0 0
Wiesbaden
Country [25] 0 0
Germany
State/province [25] 0 0
Witten
Country [26] 0 0
Greece
State/province [26] 0 0
Crete
Country [27] 0 0
Greece
State/province [27] 0 0
Athens - GR
Country [28] 0 0
Greece
State/province [28] 0 0
Athens
Country [29] 0 0
Greece
State/province [29] 0 0
Larissa
Country [30] 0 0
Greece
State/province [30] 0 0
Thessaloniki
Country [31] 0 0
Hong Kong
State/province [31] 0 0
Hong Kong
Country [32] 0 0
Hong Kong
State/province [32] 0 0
New Territories
Country [33] 0 0
Hungary
State/province [33] 0 0
Balasagyarmat
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Farkasgyepu
Country [36] 0 0
Hungary
State/province [36] 0 0
Kapuvár
Country [37] 0 0
Hungary
State/province [37] 0 0
Nyiregyhaza
Country [38] 0 0
Hungary
State/province [38] 0 0
Pécs
Country [39] 0 0
Hungary
State/province [39] 0 0
Siofok
Country [40] 0 0
Hungary
State/province [40] 0 0
Sopron
Country [41] 0 0
Hungary
State/province [41] 0 0
Szarvas
Country [42] 0 0
Hungary
State/province [42] 0 0
Veszprém
Country [43] 0 0
Israel
State/province [43] 0 0
Ashkelon
Country [44] 0 0
Israel
State/province [44] 0 0
Haifa
Country [45] 0 0
Israel
State/province [45] 0 0
Jerusalem
Country [46] 0 0
Israel
State/province [46] 0 0
Kfar-Sava
Country [47] 0 0
Israel
State/province [47] 0 0
Petach Tikva
Country [48] 0 0
Israel
State/province [48] 0 0
Rehovot
Country [49] 0 0
Israel
State/province [49] 0 0
Tel-Aviv
Country [50] 0 0
Malaysia
State/province [50] 0 0
Batu Caves
Country [51] 0 0
Malaysia
State/province [51] 0 0
Kuala Lumpur
Country [52] 0 0
Malaysia
State/province [52] 0 0
Taiping
Country [53] 0 0
Poland
State/province [53] 0 0
Bialystok
Country [54] 0 0
Poland
State/province [54] 0 0
Gdansk
Country [55] 0 0
Poland
State/province [55] 0 0
Ilawa
Country [56] 0 0
Poland
State/province [56] 0 0
Katowice
Country [57] 0 0
Poland
State/province [57] 0 0
Lodz
Country [58] 0 0
Poland
State/province [58] 0 0
Ostrow Wielkopolski
Country [59] 0 0
Poland
State/province [59] 0 0
Pila
Country [60] 0 0
Poland
State/province [60] 0 0
Poznan
Country [61] 0 0
Poland
State/province [61] 0 0
Szczecin
Country [62] 0 0
Poland
State/province [62] 0 0
Tarnow
Country [63] 0 0
Poland
State/province [63] 0 0
Wroclaw
Country [64] 0 0
Romania
State/province [64] 0 0
Jud. Constanta
Country [65] 0 0
Romania
State/province [65] 0 0
Bucharest
Country [66] 0 0
Romania
State/province [66] 0 0
Bucuresti
Country [67] 0 0
Romania
State/province [67] 0 0
Cluj Napoca
Country [68] 0 0
Romania
State/province [68] 0 0
Cluj-Napoca
Country [69] 0 0
Romania
State/province [69] 0 0
Targu Mures
Country [70] 0 0
Romania
State/province [70] 0 0
Targu-Mures
Country [71] 0 0
Singapore
State/province [71] 0 0
Singapore
Country [72] 0 0
South Africa
State/province [72] 0 0
Gauteng
Country [73] 0 0
South Africa
State/province [73] 0 0
Bloemfontein
Country [74] 0 0
South Africa
State/province [74] 0 0
Cape Town
Country [75] 0 0
South Africa
State/province [75] 0 0
Durban
Country [76] 0 0
South Africa
State/province [76] 0 0
Umkomaas
Country [77] 0 0
Spain
State/province [77] 0 0
Cataluña
Country [78] 0 0
Spain
State/province [78] 0 0
Comunidad Valenciana
Country [79] 0 0
Spain
State/province [79] 0 0
Islas Baleares
Country [80] 0 0
Sweden
State/province [80] 0 0
Göteborg
Country [81] 0 0
Sweden
State/province [81] 0 0
Lund
Country [82] 0 0
Sweden
State/province [82] 0 0
Malmö
Country [83] 0 0
Sweden
State/province [83] 0 0
Vällingby
Country [84] 0 0
Thailand
State/province [84] 0 0
Nonthaburi
Country [85] 0 0
Thailand
State/province [85] 0 0
Bangkok
Country [86] 0 0
Thailand
State/province [86] 0 0
Muang
Country [87] 0 0
Thailand
State/province [87] 0 0
Nakhon Naiyok
Country [88] 0 0
Thailand
State/province [88] 0 0
Songkla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01636076