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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02571777




Registration number
NCT02571777
Ethics application status
Date submitted
5/10/2015
Date registered
8/10/2015
Date last updated
16/07/2018

Titles & IDs
Public title
Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
Scientific title
A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
Secondary ID [1] 0 0
CQVM149B2302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QVM149
Treatment: Drugs - QVM149
Treatment: Drugs - QMF149
Treatment: Drugs - QMF149
Treatment: Drugs - salmeterol/fluticasone

Experimental: QVM149 150/50/160 µg o.d. - QVM149 150/50/160 µg o.d. delivered via Concept1

Experimental: QVM149 150/50/80 µg o.d. - QVM149 150/50/80 µg o.d. delivered via Concept1

Active Comparator: QMF149 150/160 µg o.d. - QMF149 150/160 µg o.d. delivered via Concept1

Active Comparator: QMF149 150/320 µg o.d. - QMF149 150/320 µg o.d. delivered via Concept1

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


Treatment: Drugs: QVM149


Treatment: Drugs: QVM149


Treatment: Drugs: QMF149


Treatment: Drugs: QMF149


Treatment: Drugs: salmeterol/fluticasone


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trough FEV1 - to demonstrate superiority of either QVM149 150/50/80 µg o.d. to QMF149 150/160 µg o.d. or QVM149 150/50/160 µg o.d. to QMF149 150/320 µg o.d on through FEV1 over 26 weeks of treatment. Forced Expiratory cvolume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Timepoint [1] 0 0
26 weeks
Secondary outcome [1] 0 0
Trough FEV1 at week 52 - Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
FVC at week 4 and week 12 - FVC is the total amount of air exhaled during the FEV test.
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
PEF over 26 and 52 weeks - measured in the morning and evening. PEF is the peak expiratory flow, the maximum speed of expiration.
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
ACQ-7 - ACQ is the Asthma Control Questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and the rescue medication use entered by the patient) validated to evaluate different levels of asthma control
Timepoint [4] 0 0
26 weeks, 52 weeks
Secondary outcome [5] 0 0
% days with no symptoms (overall, at awakening and rising) - Percentage of days with no symptoms, the percentage of days with no awakenings and the percentage of mornings with no symptoms on rising
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
% days without rescue medication use over 26 and 52 weeks - Percentage of days without rescue medication usage (salbutamol(albuterol) as recorded by e-diary over 26 and 52 weeks of treatment.
Timepoint [6] 0 0
52 weeks
Secondary outcome [7] 0 0
% patients with MID ACQ>= 0,5 at week 26 and 52 - Percentage of patients achieving the minimal important difference (MID) ACQ = 0.5 at Week 26 and Week 52
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
asthma exacerbation over 52 weeks - To evaluate the efficacy in terms of asthma exacerbation-related parameters :
Time to first hospitalization for asthma exacerbation
Time to first asthma exacerbation by exacerbation category
Annual rate of asthma exacerbations excluding measurements in patients requiring chronic corticosteroid use after an exacerbation (beyond permitted steroid taper for exacerbation) by exacerbation category
Duration in days of asthma exacerbations by exacerbation category
Percentage of patients with at least one asthma exacerbation by exacerbation category
Time in days to permanent discontinuation of study medication due to asthma exacerbations
Percentage of patients who permanently discontinued study medication due to asthma exacerbations
Total amounts of systemic corticosteroids (in doses) used to treat asthma exacerbations.
Timepoint [8] 0 0
52 weeks
Secondary outcome [9] 0 0
% rescue medication free days over 26 and 52 weeks - % of rescue medication free days over 26 and 52 weeks of treatment
Timepoint [9] 0 0
52 weeks
Secondary outcome [10] 0 0
AQLQ - Quality of life as assessed by Asthma Quality of Life Questionnaire (AQLQ) over 52 weeks
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Trough FEV1 at 26 weeks comparison with salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler® - In addition to the comparison QVM149 150/50/80 µg o.d. to QMF149 150/160 µg o.d. or QVM149 150/50/160 µg o.d. to QMF149 150/320 µg o.d for all above endpoints, QVM149 150/50/80 µg o.d. and QVM149 150/50/160 µg o.d. delivered via Concept1 will be compared with salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler® in all secondary enpoints above as well as Trough FEV1 measured after 26 weeks of treatment
Timepoint [11] 0 0
26 weeks
Secondary outcome [12] 0 0
Asthma control as assessed by the Asthma Control Questionnaire (ACQ-7) comparison with salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler® - In addition to the comparison QVM149 150/50/80 µg o.d. to QMF149 150/160 µg o.d. or QVM149 150/50/160 µg o.d. to QMF149 150/320 µg o.d for all above endpoints, QVM149 150/50/80 µg o.d. and QVM149 150/50/160 µg o.d. delivered via Concept1 will be compared with salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler® in all secondary enpoints and ACQ-7 at week 26
Timepoint [12] 0 0
26 weeks
Secondary outcome [13] 0 0
Serious asthma outcome incidence and CCV events/atrial fibrilaltion - Cumulative incidence of the composite endpoint of serious asthma outcomes (i.e. asthma-related hospitalization, asthma-related intubation, or asthma-related death) and CCV events/atrial fibrillation over 52 weeks of treatment
Timepoint [13] 0 0
52 weeks
Secondary outcome [14] 0 0
Adverse events, vital signs, laboratory analysis and ECG - Adverse events, vital signs, ECG and laboratory analysis (haematology, blood chemistry including glucose and potassium, urinalysis, plasma evening cortisol) and treatment discontinuation due to adverse event over 52 weeks of treatment.
Timepoint [14] 0 0
52 weeks
Secondary outcome [15] 0 0
FEV1 at week 4 and week 12 - Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Timepoint [15] 0 0
week 12

Eligibility
Key inclusion criteria
- Patients with a diagnosis of asthma, (GINA 2015) for a period of at least 1 year prior
to Visit 1 (Screening).

- Patients who have used medium or high dose of ICS/LABA combinations for asthma for at
least 3 months and at stable medium or high doses of ICS/LABA for at least 1 month
prior to Visit 1.

- Patients must be symptomatic at screening despite treatment with mid or high stable
doses of ICS/LABA. Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102
(before randomization).

- Patients with documented history of at least one asthma exacerbation which required
medical care from a physician, ER visit (or local equivalent structure) or
hospitalization in the 12 months prior to Visit 1, and required systemic
corticosteroid treatment.

- Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient
according to ATS/ERS guidelines after withholding bronchodilators at both visits 101
and 102.

- Withholding period of bronchodilators prior to spirometry: SABA for = 6 hrs, Twice
daily LABA (or FDC of ICS/LABA) for = 12 hrs, Once daily LABA (or FDC of ICS/LABA) for
= 24 hrs, SAMA for = 8 hrs, Short acting xanthines for 12 hrs, Long acting xanthines
for 24 hrs, .

- Washout period of each drug should be kept as close as possible as above and should
not be longer. If longer washout period is needed due to scheduling issues, please
contact Novartis Medical monitor.

- A one-time repeat of percentage predicated FEV1 (Pre-bronchodilator) at Visit 101
and/or Visit 102 is allowed in an ad-hoc visit. Repeat of Visit 101 spirometry 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. Run-in medication should be dispensed once
spirometry assessment met inclusion criteria (ATS/ERS quality criteria, FEV1 %
predicted normal value, and reversibility) as per equipment

- A one-time rescreen is allowed in case the patient fails to meet the criteria at the
repeat, provided the patient returned to the required treatment as per inclusion
criteria 4

- 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 then one of the following criteria need to be met.

- Reversibility should be repeated once.

- Patients may be permitted to enter the study with historical evidence of reversibility
that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1.

- 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. If
reversibility is not demonstrated at Visit 101 (or after repeated assessment in an
ad-hoc visit) and historical evidence of reversibility/bronchoprovocation is not
available (or was not performed according to the ATS/ERS guidelines patients must be
screen failed

- Spacer devices are permitted during reversibility testing only. The Investigator or
delegate may decide whether or not to use a spacer for the reversibility testing
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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). If
patients experience an asthma attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit between Visit 1 and Visit 102 they may be
re-screened 6 weeks after recovery from the exacerbation.

- 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 treated with a LAMA for asthma within 3 months prior Visit 1 (Screening).

- Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or
bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients
who are stable on treatment can be considered).

- Patients who have had a respiratory tract infection or asthma worsening as determined
by investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and
Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory
tract infection or asthma worsening.

- Patients with evidence upon visual inspection (laboratory culture is not required) of
clinically significant (in the opinion of investigator) oropharyngeal candidiasis at
Visit 102 or earlier, with or without treatment. Patients may be re-screened once
their candidiasis has been treated and has resolved.

- Patients with any chronic conditions affecting the upper respiratory tract (e.g.
chronic sinusitis) which in the opinion of the investigator may interfere with the
study evaluation or optimal participation in the study.

- Patients with a history of chronic lung diseases other than asthma, including (but not
limited to) chronic obstructive pulmonary disease, sarcoidosis, interstitial lung
disease, cystic fibrosis, clinically significant bronchiectasis and active
tuberculosis.

- Patients with Type I diabetes or uncontrolled Type II diabetes.

- Patients who, either in the judgment of the investigator or the responsible Novartis
personnel, have a clinically significant condition such as (but not limited to)
unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left
ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease,
psychiatric disease, neurodegenerative diseases, or other neurological disease,
uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia,
hyperadrenergic state, or ophthalmologic disorder or patients with a medical condition
that might compromise patient safety or compliance, interfere with evaluation, or
preclude completion of the study.

- Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded.
Patients with persistent atrial fibrillation as defined by continuous atrial
fibrillation for at least 6 months and controlled with a rate control strategy (i.e.,
selective beta blockers, calcium channel blocker, pacemaker placement, digoxin or
ablation therapy) for at least 6 months may be considered for inclusion. In such
patients, atrial fibrillation must be present at the run-in visit (Visit 101) with a
resting ventricular rate < 100/min. At Visit 101 the atrial fibrillation must be
confirmed by central reading.

- Patients with a history of myocardial infarction (this should be confirmed clinically
by the investigator) within the previous 12 months.

- Concomitant use of agents known to prolong the QT interval unless it can be
permanently discontinued for the duration of study

- Patients with a history of long QT syndrome or whose QTc measured at Visit 101
(Fridericia method) is prolonged (> 450 msec for males and > 460 msec for females) and
confirmed by a central assessor (these patients should not be rescreened).

- Patients with a history of hypersensitivity to lactose, any of the study drugs or to
similar drugs within the class including untoward reactions to sympathomimetic amines
or inhaled medication or any component thereof.

- Patients who have not achieved an acceptable spirometry result at Visit 101 in
accordance with ATS/ERS criteria for acceptability and repeatability. A one-time
repeat spirometry is allowed in an ad-hoc visit scheduled as close as possible from
the first attempt (but not on the same day) if the spirometry did not qualify due to
ATS/ERS criteria at Visit 101 and/or Visit 102. If the patient fails the repeat
assessment, the patient may be rescreened once, provided the patient returns to the
required treatment as per inclusion criteria 4.

- Patients unable to use the Concept1 dry powder inhaler, Accuhaler or a metered dose
inhaler. Spacer devices are not permitted.

- History of alcohol or other substance abuse.

- Patients with a known history of non-compliance to medication or who were unable or
unwilling to complete a patient diary or who are unable or unwilling to use Electronic
Peak Flow with e-diary device.

- Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night
shift workers).

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
SA,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Bedford Park
Recruitment hospital [2] 0 0
Novartis Investigative Site - Murdoch
Recruitment hospital [3] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
5041 - Bedford Park
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Cordoba
Country [3] 0 0
Argentina
State/province [3] 0 0
Entre Rios
Country [4] 0 0
Argentina
State/province [4] 0 0
Mendoza
Country [5] 0 0
Argentina
State/province [5] 0 0
Rosario
Country [6] 0 0
Argentina
State/province [6] 0 0
Santa Fe
Country [7] 0 0
Argentina
State/province [7] 0 0
Tucuman
Country [8] 0 0
Argentina
State/province [8] 0 0
Parana
Country [9] 0 0
Austria
State/province [9] 0 0
Bludenz
Country [10] 0 0
Austria
State/province [10] 0 0
Feldbach
Country [11] 0 0
Austria
State/province [11] 0 0
Feldkirch
Country [12] 0 0
Austria
State/province [12] 0 0
Grieskirchen
Country [13] 0 0
Austria
State/province [13] 0 0
Wien
Country [14] 0 0
Belgium
State/province [14] 0 0
BEL
Country [15] 0 0
Belgium
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Braine l'Alleud
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussel
Country [17] 0 0
Belgium
State/province [17] 0 0
Bruxelles
Country [18] 0 0
Belgium
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Eghezee
Country [19] 0 0
Belgium
State/province [19] 0 0
Erpent
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Belgium
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Herentals
Country [21] 0 0
Belgium
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Kortrijk
Country [22] 0 0
Belgium
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Lebbeke
Country [23] 0 0
Belgium
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Liege
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Belgium
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Malmedy
Country [25] 0 0
Belgium
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Sint-Niklaas
Country [26] 0 0
Bulgaria
State/province [26] 0 0
BGR
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Ruse
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Stara Zagora
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
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Quebec
Country [33] 0 0
Chile
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Region Metropolitana
Country [34] 0 0
Chile
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TX
Country [35] 0 0
Chile
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VII Region Del Maule
Country [36] 0 0
Chile
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Santiago
Country [37] 0 0
China
State/province [37] 0 0
Hainan
Country [38] 0 0
China
State/province [38] 0 0
Hubei
Country [39] 0 0
China
State/province [39] 0 0
Jiangsu
Country [40] 0 0
China
State/province [40] 0 0
Jilin
Country [41] 0 0
China
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Liaoning
Country [42] 0 0
China
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Shandong
Country [43] 0 0
China
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Shanghai
Country [44] 0 0
China
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Shanxi
Country [45] 0 0
China
State/province [45] 0 0
Sichuan
Country [46] 0 0
China
State/province [46] 0 0
Beijing
Country [47] 0 0
China
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Chengdu
Country [48] 0 0
China
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Chongqing
Country [49] 0 0
China
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Guangzhou
Country [50] 0 0
China
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Tianjin
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Colombia
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Bogota
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Colombia
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Floridablanca
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Colombia
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Medellin
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Croatia
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HRV
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Croatia
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Petrinja
Country [56] 0 0
Croatia
State/province [56] 0 0
Zadar
Country [57] 0 0
Croatia
State/province [57] 0 0
Zagreb
Country [58] 0 0
Denmark
State/province [58] 0 0
Copenhagen NV
Country [59] 0 0
Denmark
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Hvidovre
Country [60] 0 0
Estonia
State/province [60] 0 0
Tallinn
Country [61] 0 0
Estonia
State/province [61] 0 0
Tartu
Country [62] 0 0
Finland
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Jyvaskyla
Country [63] 0 0
Finland
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Turku
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France
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Besancon Cedex
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France
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Montpellier
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Germany
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NRW
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Germany
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Sachsen
Country [68] 0 0
Germany
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Schleswig Holstein
Country [69] 0 0
Germany
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Annaberg-Buchholz
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Germany
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Aschaffenburg
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Bonn
Country [74] 0 0
Germany
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Darmstadt
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Germany
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Frankfurt am Main
Country [76] 0 0
Germany
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Frankfurt
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Germany
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Halberstadt
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Germany
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Halle
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Germany
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Hamburg
Country [80] 0 0
Germany
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Hannover
Country [81] 0 0
Germany
State/province [81] 0 0
Hettstedt
Country [82] 0 0
Germany
State/province [82] 0 0
Kamenz
Country [83] 0 0
Germany
State/province [83] 0 0
Karlsruhe
Country [84] 0 0
Germany
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Leipzig
Country [85] 0 0
Germany
State/province [85] 0 0
Lübeck
Country [86] 0 0
Germany
State/province [86] 0 0
Mainz
Country [87] 0 0
Germany
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Mittweida
Country [88] 0 0
Germany
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Neu Isenburg
Country [89] 0 0
Germany
State/province [89] 0 0
Neuss
Country [90] 0 0
Germany
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Potsdam
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Germany
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Rudersdorf
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Germany
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Warendorf
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Germany
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Witten
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Germany
State/province [94] 0 0
Zerbst
Country [95] 0 0
Greece
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GR
Country [96] 0 0
Greece
State/province [96] 0 0
Athens
Country [97] 0 0
Greece
State/province [97] 0 0
Thessaloniki
Country [98] 0 0
Hungary
State/province [98] 0 0
HUN
Country [99] 0 0
Hungary
State/province [99] 0 0
Balassagyarmat
Country [100] 0 0
Hungary
State/province [100] 0 0
Budapest
Country [101] 0 0
Hungary
State/province [101] 0 0
Godollo
Country [102] 0 0
Hungary
State/province [102] 0 0
Kaposvar
Country [103] 0 0
Hungary
State/province [103] 0 0
Komarom
Country [104] 0 0
Hungary
State/province [104] 0 0
Mateszalka
Country [105] 0 0
Hungary
State/province [105] 0 0
Nyiregyhaza
Country [106] 0 0
Hungary
State/province [106] 0 0
Szarvas
Country [107] 0 0
Hungary
State/province [107] 0 0
Szeged
Country [108] 0 0
Hungary
State/province [108] 0 0
Szigetszentmiklos
Country [109] 0 0
Hungary
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Szigetvar
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India
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Andhra Pradesh
Country [111] 0 0
India
State/province [111] 0 0
Delhi
Country [112] 0 0
India
State/province [112] 0 0
Gujarat
Country [113] 0 0
India
State/province [113] 0 0
Haryana
Country [114] 0 0
India
State/province [114] 0 0
Karnataka
Country [115] 0 0
India
State/province [115] 0 0
Kerala
Country [116] 0 0
India
State/province [116] 0 0
Maharashtra
Country [117] 0 0
India
State/province [117] 0 0
Punjab
Country [118] 0 0
India
State/province [118] 0 0
Rajasthan
Country [119] 0 0
India
State/province [119] 0 0
Tamil Nadu
Country [120] 0 0
India
State/province [120] 0 0
Tamil NADU
Country [121] 0 0
India
State/province [121] 0 0
Tamilnadu
Country [122] 0 0
India
State/province [122] 0 0
Telangana
Country [123] 0 0
India
State/province [123] 0 0
Uttar Pradesh
Country [124] 0 0
India
State/province [124] 0 0
Uttarakhand
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Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the trial is to evaluate the efficacy and safety of two different doses of
QVM149 (QVM149 150/50/80 µg and QVM149 150/50/160 µg via Concept1) over two respective QMF149
doses (QMF149 150/160 µg and QMF149 150/320 µg via Concept1 in poorly controlled asthmatics
as determined by pulmonary function testing and effects on asthma control.
Trial website
https://clinicaltrials.gov/show/NCT02571777
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
+41613241111
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02571777