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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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 [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Trough FEV1 After First Dose and After 4 Weeks of Treatment - Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 1 hours on Day 1 and Day 28; 24 hours post-dose on Day 29 and 85. In a subset of approximately 60 patients, FEV1 is measured up to 20 hours postdose on Day 28 and Day 84.
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 - Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.
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 - Spirometry is conducted according to the global standard. FEV1/FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.
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) - Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), Scheduled (not actual) time points are to be used. The standardized AUC(5 min - 4 h) for FEV1 will be summarized by treatment.
Timepoint [5] 0 0
Day 1
Secondary outcome [6] 0 0
FEV1 AUC (5 Min-4 h), - Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min - 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.
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) - Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min - 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.
Timepoint [7] 0 0
Day 28, Day 84
Secondary outcome [8] 0 0
The Usage of Rescue Medication (Short Acting ß2-agonist) - Participants record the number of puffs of rescue medication taken in the previous 12 hours each morning and evening throughout the 12 week treatment period.
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
The Overall Change in Usage of Rescue Medication (Short Acting ß2-agonist) . - This value represents the percent of days in the study where no rescue medication was needed.
Timepoint [9] 0 0
Baseline to 12 weeks
Secondary outcome [10] 0 0
Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire) - A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.
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 - A TDI focal score of =1 is considered to be a clinically important improvement from baseline. Analysis of the proportion of subjects with a clinically important improvement of >=1 point in the TDI focal score, by visit
Timepoint [11] 0 0
4 and 12 weeks
Secondary outcome [12] 0 0
Patient Reported Outcome Measures: COPD Assessment Test - It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.
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 - Scoring the MOS Sleep Survey is a two-step process:• All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. For example, a score of 50 represents 50% of the highest possible score.
• Second, items within each scale are averaged together to create the 7 scale scores. Scales with at least one item answered can be used to generate a scale score. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scores represent the average for all items in the scale that the respondent answered. An additional measure is based on the average number of hours sleep each night during the past 4 weeks and are described in outcome measure 15.
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 - The sleep quantity subscale,which refers to question 2 of the PRO: On average, how many hours did you sleep each night during the past 4 weeks. More hours of sleep indicate better outcome.
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) - The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.
Timepoint [15] 0 0
12 weeks
Secondary outcome [16] 0 0
Time to First COPD Exacerbation - Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that were event free of a specified event.
Timepoint [16] 0 0
12 weeks
Secondary outcome [17] 0 0
Annual Rate of COPD Exacerbations - Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.
Timepoint [17] 0 0
12 weeks
Secondary outcome [18] 0 0
Duration (in Days) of COPD Exacerbations - Duration and number of the COPD exacerbation will be analyzed by the negative binomial regression model including treatment, country, smoking status, and COPD severity as factors and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.
Timepoint [18] 0 0
12 weeks
Secondary outcome [19] 0 0
Percentage of Patients With at Least One Exacerbation up to Week 12 - Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that had an exacerbation up to week 12. Less exacerbations reflect a better outcome.
Timepoint [19] 0 0
12 weeks
Secondary outcome [20] 0 0
Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation - Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.
Timepoint [20] 0 0
12 weeks
Secondary outcome [21] 0 0
The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation - Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.
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 - Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.
Timepoint [22] 0 0
12 weeks
Secondary outcome [23] 0 0
Plasma Cortisol Concentrations at Each Timepoint - Plasma cortisol to be measured in a subset of approximately 60 patients via central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1, up to 12 hours post-dose on Day 28 and Day 84, and 23 hour 35 minute on Day 2, Day 29, and Day 85, and at pre-dose 25 minute on Day 28, and Day 84.
Timepoint [23] 0 0
Day 1, Day 28, Day 84
Secondary outcome [24] 0 0
Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint - Plasma indacaterol and mometasone furoate is to be measured in a subset of approximately 60 patients via central laboratory. Blood samples are collected at pre-dose on Day 1, 29, and 84; and post dose up to 4 hour on Day 1, up to 12 hours on Day 28 and 84. For sparse pharmacokinetic testing, blood samples will be collected at 23h 35 min post-dose following morning dose administration on Day 28 and 84, in all patients participating in this study.
Timepoint [24] 0 0
Day 1, 29, 84
Secondary outcome [25] 0 0
Pharmacokinetic Parameter: Cmax - Maximum observed plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.
Timepoint [25] 0 0
Day 28, 84
Secondary outcome [26] 0 0
Pharmacokinetic Parameter--Tmax - Time to reach the maximum plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.
Timepoint [26] 0 0
Day 28, 84
Secondary outcome [27] 0 0
Pharmacokinetic Parameter--AUC0-t - Area under the plasma concentration time curve from time zero to time "t" post-dose is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to
salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with
COPD
Trial website
https://clinicaltrials.gov/show/NCT01636076
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

Summary results
Other publications