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CompletedNCT00941798Updated Aug 31, 2012Results posted

Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

A Phase 2 interventional study of QMF149 Twisthaler® and Mometasone Twisthaler® in Asthma, sponsored by Novartis Pharmaceuticals. Completed at 146 sites in 9 countries. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-08-31.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
2,283
Allocation
Randomized
Ages
12 Years to 70 Years
Sex
All
01

Study summary

Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.

02

Conditions studied

  • Asthma

Browse trials for

Keywords

  • Asthma
  • LABA
  • Safety
03

In context

Asthma

4,012 studies on the registry are indexed under Asthma; 514 are open to participants now.

This study's enrollment of 2,283 is above the median of 83 across 2,814 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,711 studies on the registry; 218 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 435 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination
  • Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% or ≥ 200 mLs within 30 minutes after administration of short-acting beta2-agonist (SABA)
  • Patients with an FEV1 ≥ 50% of predicted normal

Exclusion criteria

Exclusion Criteria:

  • Patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD)
  • Patients who had an asthma attack/exacerbation requiring hospitalization/emergency room visit or respiratory tract infection within 1 month prior to randomization
  • Patients who had ever required ventilator support for respiratory failure
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Patients with concomitant pulmonary disease
  • Patients with certain cardiovascular co-morbid conditions
  • Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,283 participants (actual)

Study arms

  • Experimental
    QMF149 Twisthaler® 500/400

    QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)

    Drug: QMF149 Twisthaler®

  • Active comparator
    Mometasone Twisthaler®

    Mometasone Twisthaler®, 400 µg QD

    Drug: Mometasone Twisthaler®

Interventions

  • DrugQMF149 Twisthaler®

    Once daily via multi-dose dry-powder inhaler

  • DrugMometasone Twisthaler®

    Once daily via multi-dose dry-powder inhaler

06

What researchers measure

Primary outcomes

  1. Time to First Serious Asthma Exacerbation

    Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.

    Time frame: Up to 21 months

Secondary outcomes

  1. Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.

    The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.

    Time frame: up to 21 months

  2. Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids

    Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).

    Time frame: Up to 21 months

  3. Number of Patients With at Least One Asthma Worsening Post-baseline

    The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) \>= 20% from mean baseline on \>= 3 consecutive days, nighttime symptom score \>= 2 on \>= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) \>=20% from baseline at evening visits, daytime symptom score of 3 or 4 on \>= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use \>= 8 puffs on \>= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).

    Time frame: Up to 21 months

  4. Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit

    Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

    Time frame: Baseline to the end of treatment (varying durations, up to 21 months)

  5. Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit

    Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

    Time frame: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose

  6. Change From Baseline in Forced Vital Capacity (FVC) at Final Visit

    Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment\*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

    Time frame: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose

  7. Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period

    PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits. Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient.

    Time frame: Baseline to the end of treatment (varying durations, up to 21 months)

  8. Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime

    Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.

    Time frame: Baseline to the end of treatment (varying durations, up to 21 months)

  9. Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime

    Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.

    Time frame: Baseline to the end of treatment (varying durations, up to 21 months)

  10. Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime

    24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.

    Time frame: Baseline to the end of treatment (varying durations, up to 21 months)

  11. Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit

    The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control. Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment\*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

    Time frame: Baseline to the end of treatment (varying durations, up to 21 months)

07

Results

Posted Jun 5, 2012

Participant flow

Participant flow — Overall Study
MilestoneQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Started755763
Full analysis set749759
Completed561578
Not completed194185
Withdrew: Withdrawal by subject7274
Withdrew: Adverse event4323
Withdrew: Lost to follow-up2923
Withdrew: Protocol violation1720
Withdrew: Administrative problems1323
Withdrew: Lack of efficacy1017
Withdrew: Patient's inability to use device61
Withdrew: Abnormal test procedure results31
Withdrew: Abnormal laboratory values12
Withdrew: Death01

Outcome measures

PrimaryTime to First Serious Asthma Exacerbation

Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.

Time frame:
Up to 21 months
Reported as:
Median · months
Time to First Serious Asthma Exacerbation
monthsQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Time to First Serious Asthma Exacerbation13.3 (0.0 to 19.6)13.4 (0.0 to 20.3)
SecondaryCumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.

The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death.

Time frame:
up to 21 months
Reported as:
Number · participants
Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.
participantsQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.26
SecondaryPatients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids

Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months).

Time frame:
Up to 21 months
Reported as:
Number · participants
Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids
participantsQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids124171
SecondaryNumber of Patients With at Least One Asthma Worsening Post-baseline

The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) \>= 20% from mean baseline on \>= 3 consecutive days, nighttime symptom score \>= 2 on \>= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) \>=20% from baseline at evening visits, daytime symptom score of 3 or 4 on \>= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use \>= 8 puffs on \>= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms).

Time frame:
Up to 21 months
Reported as:
Number · participants
Number of Patients With at Least One Asthma Worsening Post-baseline
participantsQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Number of Patients With at Least One Asthma Worsening Post-baseline533637
SecondaryChange From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit

Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

Time frame:
Baseline to the end of treatment (varying durations, up to 21 months)
Reported as:
Least squares mean · liters
Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit
litersQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit0.06 ± 0.025-0.07 ± 0.024
SecondaryChange From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit

Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment\*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

Time frame:
Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose
Reported as:
Least squares mean · liters
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
litersQMF149 Twisthaler® 500/400Mometasone Twisthaler®
5 minutes post-dose (n = 578, 607)0.09 ± 0.018-0.04 ± 0.018
30 minutes post-dose (n = 576, 605)0.12 ± 0.020-0.05 ± 0.020
1 hour post-dose (n = 575, 602)0.13 ± 0.021-0.06 ± 0.021
2 hours post-dose (n = 568, 601)0.14 ± 0.022-0.05 ± 0.022
SecondaryChange From Baseline in Forced Vital Capacity (FVC) at Final Visit

Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment\*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

Time frame:
Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose
Reported as:
Least squares mean · liter
Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
literQMF149 Twisthaler® 500/400Mometasone Twisthaler®
5 minutes post-dose (n = 578, 607)-0.03 ± 0.023-0.11 ± 0.023
30 minutes post-dose (n = 576, 605)-0.03 ± 0.025-0.13 ± 0.024
1 hour post-dose (n = 575, 602)-0.01 ± 0.025-0.13 ± 0.025
2 hours post-dose (n = 568, 601)-0.02 ± 0.026-0.13 ± 0.026
SecondaryChanges From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period

PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits. Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient.

Time frame:
Baseline to the end of treatment (varying durations, up to 21 months)
Reported as:
Least squares mean · liters per second
Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period
liters per secondQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Morning PEF (n = 730, 746)0.43 ± 0.0750.00 ± 0.075
Evening PEF (n = 731, 748)0.27 ± 0.076-0.15 ± 0.075
SecondaryChange From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime

Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.

Time frame:
Baseline to the end of treatment (varying durations, up to 21 months)
Reported as:
Least squares mean · percentage of days
Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime
percentage of daysQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Morning (n = 730, 746)22.3 ± 2.1718.4 ± 2.17
Daytime (n = 731, 749)27.1 ± 2.9619.5 ± 2.95
Nighttime (n = 730, 746)23.6 ± 2.6917.3 ± 2.68
SecondaryChange From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime

Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.

Time frame:
Baseline to the end of treatment (varying durations, up to 21 months)
Reported as:
Least squares mean · units on a scale
Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime
units on a scaleQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Total (n = 708, 733)-1.22 ± 0.088-0.94 ± 0.088
Daytime (n = 731, 749)-0.50 ± 0.043-0.39 ± 0.043
Nighttime (n = 730, 746)-0.46 ± 0.037-0.36 ± 0.037
SecondaryChange From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime

24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient.

Time frame:
Baseline to the end of treatment (varying durations, up to 21 months)
Reported as:
Least squares mean · percentage of days
Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime
percentage of daysQMF149 Twisthaler® 500/400Mometasone Twisthaler®
24 hours (n = 669, 696)29.1 ± 2.8817.9 ± 2.88
Daytime (n = 692, 711)23.6 ± 2.7413.8 ± 2.74
Nighttime (n = 691, 708)24.6 ± 2.6914.5 ± 2.68
SecondaryChange From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit

The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control. Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment\*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient.

Time frame:
Baseline to the end of treatment (varying durations, up to 21 months)
Reported as:
Least squares mean · units on a scale
Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit
units on a scaleQMF149 Twisthaler® 500/400Mometasone Twisthaler®
Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit-0.55 ± 0.052-0.32 ± 0.052

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
QMF149 Twisthaler® 500/400—30/749 (4%)510/749 (68.1%)
Mometasone Twisthaler®—44/759 (5.8%)477/759 (62.8%)
Most frequent serious events
Showing 10 of 76
Most frequent serious events
EventQMF149 Twisthaler® 500/400Mometasone Twisthaler®
AsthmaRespiratory, thoracic and mediastinal disorders2/7499/759
PneumoniaInfections and infestations0/7494/759
PregnancyPregnancy, puerperium and perinatal conditions3/7491/759
NauseaGastrointestinal disorders2/7490/759
VomitingGastrointestinal disorders2/7490/759
CholelithiasisHepatobiliary disorders2/7490/759
AppendicitisInfections and infestations2/7492/759
Inguinal herniaGastrointestinal disorders0/7492/759
Chest painGeneral disorders1/7492/759
Non-cardiac chest painGeneral disorders0/7492/759
Most frequent other events
Showing 10 of 25
Most frequent other events
EventQMF149 Twisthaler® 500/400Mometasone Twisthaler®
CoughRespiratory, thoracic and mediastinal disorders266/74963/759
AsthmaRespiratory, thoracic and mediastinal disorders195/749269/759
NasopharyngitisInfections and infestations112/749106/759
Upper respiratory tract infectionInfections and infestations83/74996/759
BronchitisInfections and infestations39/74958/759
SinusitisInfections and infestations55/74952/759
Viral upper respiratory tract infectionInfections and infestations29/74936/759
HeadacheNervous system disorders26/74930/759
PharyngitisInfections and infestations29/74927/759
Rhinitis allergicRespiratory, thoracic and mediastinal disorders29/74925/759

Baseline characteristics

Age Continuous
Age Continuous(years)QMF149 Twisthaler® 500/400Mometasone Twisthaler®Total
Mean42.4 ± 14.7542.3 ± 14.5842.3 ± 14.66
Sex: Female, Male
Sex: Female, Male(Participants)QMF149 Twisthaler® 500/400Mometasone Twisthaler®Total
Female436449885
Male313310623
08

Study locations

146 sites
  • Novartis Investigator Site
    Birmingham, Alabama 35209, United States
  • Novartis Investigator Site
    Buena Park, California 90620, United States
  • Novartis Investigator Site
    Encinitas, California 92024, United States
  • Novartis Investigator Site
    Fullerton, California 92835, United States
  • Novartis Investigator Site
    Long Beach, California 90808, United States
  • Novartis Investigator Site
    Los Angeles, California 90025, United States
  • Novartis Investigator Site
    Orange, California 92868, United States
  • Novartis Investigator Site
    Riverside, California 92506, United States
  • Novartis Investigator Site
    San Diego, California 92123, United States
  • Novartis Investigator Site
    San Jose, California 95117, United States
  • Novartis Investigator Site
    San Mateo, California 94401, United States
  • Novartis Investigator Site
    Vista, California 92083, United States
  • Novartis Investigator Site
    Walnut Creek, California 94598, United States
  • Novartis Investigator Site
    Denver, Colorado 80230, United States
  • Novartis Investigator Site
    Engelwood, Colorado 80112, United States
  • Novartis Investigator Site
    Lakewood, Colorado 80401, United States
  • Novartis Investigator Site
    Wheat Ridge, Colorado 80033, United States
  • Novartis Investigator Site
    Clearwater, Florida 33756, United States
  • Novartis Investigator Site
    Clearwater, Florida 33765, United States
  • Novartis Investigative Site
    Miami, Florida 33136, United States
  • Novartis Investigative Site
    Miami, Florida 33157, United States
  • Novartis Investigator Site
    Port Charlotte, Florida 33952, United States
  • Novartis Investigator Site
    Sarasota, Florida 34233, United States
  • Novartis Investigative Site
    South Miami, Florida 33143, United States
  • Novartis Investigator Site
    Tampa, Florida 33603, United States
  • Novartis Investigative Site
    Albany, Georgia 31707, United States
  • Novartis Investigative Site
    Columbus, Georgia 31904, United States
  • Novartis Investigative Site
    Savannah, Georgia 31406, United States
  • Novartis Investigator Site
    Couer D'Alene, Idaho 83814, United States
  • Novartis Investigator Site
    Chicago, Illinois 60612, United States
  • Novartis Investigator Site
    Normal, Illinois 61761, United States
  • Novartis Investigator Site
    River Forest, Illinois 60305, United States
  • Novartis Investigator Site
    Skokie, Illinois 60076, United States
  • Novartis Investigator Site
    Springfield, Illinois 62703, United States
  • Novartis Investigator Site
    Evansville, Indiana 47713, United States
  • Novartis Investigator Site
    Indianapolis, Indiana 46208, United States
  • Novartis Investigator Site
    Iowa City, Iowa 52240, United States
  • Novartis Investigator Site
    Topeka, Kansas 66606, United States
  • Novartis Investigator Site
    Owensboro, Kentucky 42301, United States
  • Novartis Investigator Site
    Metarie, Louisiana 70002, United States
  • Novartis Investigative Site
    Bangor, Maine 04401, United States
  • Novartis Investigative Site
    Baltimore, Maryland 21236, United States
  • Novartis Investigative Site
    Baltimore, Maryland 21237, United States
  • Novartis Investigative Site
    North Dartmouth, Massachusetts 02747, United States
  • Novartis Investigator Site
    Minneapolis, Minnesota 55402, United States
  • Novartis Investigator Site
    Plymouth, Minnesota 55441, United States
  • Novartis Investigator Site
    Ozark, Missouri 65721, United States
  • Novartis Investigator Site
    Rolla, Missouri 65401, United States
  • Novartis Investigator Site
    St Louis, Missouri 63141, United States
  • Novartis Investigator Site
    Warrensburg, Missouri 64093, United States
  • Novartis Investigator Site
    Bellevue, Nebraska 68123, United States
  • Novartis Investigator Site
    Omaha, Nebraska 68130, United States
  • Novartis Investigator Site
    Omaha, Nebraska 68131, United States
  • Novartis Investigative Site
    Brick, New Jersey 08724, United States
  • Novartis Investigative Site
    Cedar Knolls, New Jersey 07927, United States
  • Novartis Investigative Site
    Skillman, New Jersey 08558, United States
  • Novartis Investigator Site
    Albuquerque, New Mexico 87108, United States
  • Novartis Investigative Site
    Mineola, New York 11501, United States
  • Novartis Investigative Site
    Newburgh, New York 12550, United States
  • Novartis Investigative Site
    Rochester, New York 14618-2638, United States
  • Novartis Investigative Site
    High Point, North Carolina 27262, United States
  • Novartis Investigative site
    Raleigh, North Carolina 27607, United States
  • Novartis Investigator Site
    Canton, Ohio 44718, United States
  • Novartis Investigator Site
    Columbus, Ohio 43213, United States
  • Novartis Investigator Site
    Marion, Ohio 43302, United States
  • Novartis Investigator Site
    Sylvania, Ohio 43560, United States
  • Novartis Investigative Site
    Oklahoma City, Oklahoma 73104, United States
  • Novartis Investigator Site
    Oklahoma City, Oklahoma 73112, United States
  • Novartis Investigator Site
    Oklahoma City, Oklahoma 73120, United States
  • Novartis Investigator Site
    Portland, Oregon 97213, United States
  • Novartis Investigative Site
    Blue Bell, Pennsylvania 19422, United States
  • Novartis Investigative Site
    Philadelphia, Pennsylvania 19115, United States
  • Novartis Investigative site
    Philadelphia, Pennsylvania 19140, United States
  • Novartis Investigative Site
    Pittsburgh, Pennsylvania 15221, United States
  • Novartis Investigator Site
    Lincoln, Rhode Island 02865, United States
  • Novartis Investigative Site
    Mt. Pleasant, South Carolina 29464, United States
  • Novartis Investigator Site
    Kingsport, Tennessee 37660, United States
  • Novartis Investigator Site
    Dallas, Texas 75230, United States
  • Novartis Investigator Site
    Dallas, Texas 75231, United States
  • Novartis Investigator Site
    Dickinson, Texas 77539, United States
  • Novartis Investigator Site
    El Paso, Texas 79925, United States
  • Novartis Investigator Site
    Fort Worth, Texas 76132, United States
  • Novartis Investigative Site
    Houston, Texas 77030, United States
  • Novartis Investigator Site
    Houston, Texas 77054, United States
  • Novartis Investigator Site
    New Braunfels, Texas 78130, United States
  • Novartis Investigator Site
    San Antonio, Texas 78229, United States
  • Novartis Investigative Site
    South Burlington, Vermont 05403, United States
  • Novartis Investigative Site
    Abingdon, Virginia 24210, United States
  • Novartis Investigator Site
    Kirkland, Washington 98034, United States
  • Novartis Investigator Site
    Seattle, Washington 98105, United States
  • Novartis Investigator Site
    Tacoma, Washington 98405, United States
  • Novartis Investigator Site
    Milwaukee, Wisconsin 53209, United States
  • Novartis Investigative Site
    Belo Horizonte, Brazil
  • Novartis Investigative Site
    Florianópolis, Brazil
  • Novartis Investigative Site
    Porto Alegre, Brazil
  • Novartis Investigative Site
    Rio de Janeiro, Brazil
  • Novartis Investigative Site
    Salvador, Brazil
  • Novartis Investigative Site
    São Paulo, Brazil
  • Novartis Investigative Site
    Barranquilla, Colombia
  • Novartis Investigative Site
    Bogotá, Colombia

Showing the first 100 of 146 sites across 9 countries.

09

References and documents

Publications

  • Beasley RW, Donohue JF, Mehta R, Nelson HS, Clay M, Moton A, Kim HJ, Hederer BM. Effect of once-daily indacaterol maleate/mometasone furoate on exacerbation risk in adolescent and adult asthma: a double-blind randomised controlled trial. BMJ Open. 2015 Feb 3;5(2):e006131. doi: 10.1136/bmjopen-2014-006131. PubMed 25649209 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2009, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2012, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2009
First posted
Jul 20, 2009
Start
Jul 2009
Primary completionActual
May 2011
CompletionActual
May 2011
Results first posted
Jun 5, 2012
Last update
Aug 31, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00941798
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 20, 2009
Start date
Jul 2009
Primary completion
May 2011
Completion
May 2011
Results posted
Jun 5, 2012
Last update
Aug 31, 2012

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: QMF149

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