AsthmaPhase 2NCT00941798
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
A Phase 2 study testing QMF149 Twisthaler® and Mometasone Twisthaler® in people with Asthma, run by Novartis Pharmaceuticals at 146 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- QMF149 Twisthaler® and Mometasone Twisthaler®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,283 participants
- Where
- 146 sitesin 9 countries
- Study dates
- Jul 2009to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
146 sites in 9 countries.
146 sites in 9 countries
United States92 sites
Novartis Investigative Site
Abingdon, Virginia, 24210
Novartis Investigative Site
Albany, Georgia, 31707
Novartis Investigator Site
Albuquerque, New Mexico, 87108
Novartis Investigative Site
Baltimore, Maryland, 21236
Novartis Investigative Site
Baltimore, Maryland, 21237
Novartis Investigative Site
Bangor, Maine, 04401
Novartis Investigator Site
Bellevue, Nebraska, 68123
Novartis Investigator Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Blue Bell, Pennsylvania, 19422
Novartis Investigative Site
Brick, New Jersey, 08724
Novartis Investigator Site
Buena Park, California, 90620
Novartis Investigator Site
Canton, Ohio, 44718
Novartis Investigative Site
Cedar Knolls, New Jersey, 07927
Novartis Investigator Site
Chicago, Illinois, 60612
Novartis Investigator Site
Clearwater, Florida, 33756
Novartis Investigator Site
Clearwater, Florida, 33765
Novartis Investigative Site
Columbus, Georgia, 31904
Novartis Investigator Site
Columbus, Ohio, 43213
Novartis Investigator Site
Couer D'Alene, Idaho, 83814
Novartis Investigator Site
Dallas, Texas, 75230
Novartis Investigator Site
Dallas, Texas, 75231
Novartis Investigator Site
Denver, Colorado, 80230
Novartis Investigator Site
Dickinson, Texas, 77539
Novartis Investigator Site
El Paso, Texas, 79925
Novartis Investigator Site
Encinitas, California, 92024
Novartis Investigator Site
Engelwood, Colorado, 80112
Novartis Investigator Site
Evansville, Indiana, 47713
Novartis Investigator Site
Fort Worth, Texas, 76132
Novartis Investigator Site
Fullerton, California, 92835
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigator Site
Houston, Texas, 77054
Novartis Investigator Site
Indianapolis, Indiana, 46208
Novartis Investigator Site
Iowa City, Iowa, 52240
Novartis Investigator Site
Kingsport, Tennessee, 37660
Novartis Investigator Site
Kirkland, Washington, 98034
Novartis Investigator Site
Lakewood, Colorado, 80401
Novartis Investigator Site
Lincoln, Rhode Island, 02865
Novartis Investigator Site
Long Beach, California, 90808
Novartis Investigator Site
Los Angeles, California, 90025
Novartis Investigator Site
Marion, Ohio, 43302
Novartis Investigator Site
Metarie, Louisiana, 70002
Novartis Investigative Site
Miami, Florida, 33136
Novartis Investigative Site
Miami, Florida, 33157
Novartis Investigator Site
Milwaukee, Wisconsin, 53209
Novartis Investigative Site
Mineola, New York, 11501
Novartis Investigator Site
Minneapolis, Minnesota, 55402
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464
Novartis Investigator Site
New Braunfels, Texas, 78130
Novartis Investigative Site
Newburgh, New York, 12550
Novartis Investigator Site
Normal, Illinois, 61761
Novartis Investigative Site
North Dartmouth, Massachusetts, 02747
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104
Novartis Investigator Site
Oklahoma City, Oklahoma, 73112
Novartis Investigator Site
Oklahoma City, Oklahoma, 73120
Novartis Investigator Site
Omaha, Nebraska, 68130
Novartis Investigator Site
Omaha, Nebraska, 68131
Novartis Investigator Site
Orange, California, 92868
Novartis Investigator Site
Owensboro, Kentucky, 42301
Novartis Investigator Site
Ozark, Missouri, 65721
Novartis Investigative Site
Philadelphia, Pennsylvania, 19115
Novartis Investigative site
Philadelphia, Pennsylvania, 19140
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15221
Novartis Investigator Site
Plymouth, Minnesota, 55441
Novartis Investigator Site
Port Charlotte, Florida, 33952
Novartis Investigator Site
Portland, Oregon, 97213
Novartis Investigative site
Raleigh, North Carolina, 27607
Novartis Investigator Site
River Forest, Illinois, 60305
Novartis Investigator Site
Riverside, California, 92506
Novartis Investigative Site
Rochester, New York, 14618-2638
Novartis Investigator Site
Rolla, Missouri, 65401
Novartis Investigator Site
San Antonio, Texas, 78229
Novartis Investigator Site
San Diego, California, 92123
Novartis Investigator Site
San Jose, California, 95117
Novartis Investigator Site
San Mateo, California, 94401
Novartis Investigator Site
Sarasota, Florida, 34233
Novartis Investigative Site
Savannah, Georgia, 31406
Novartis Investigator Site
Seattle, Washington, 98105
Novartis Investigative Site
Skillman, New Jersey, 08558
Novartis Investigator Site
Skokie, Illinois, 60076
Novartis Investigative Site
South Burlington, Vermont, 05403
Novartis Investigative Site
South Miami, Florida, 33143
Novartis Investigator Site
Springfield, Illinois, 62703
Novartis Investigator Site
St Louis, Missouri, 63141
Novartis Investigator Site
Sylvania, Ohio, 43560
Novartis Investigator Site
Tacoma, Washington, 98405
Novartis Investigator Site
Tampa, Florida, 33603
Novartis Investigator Site
Topeka, Kansas, 66606
Novartis Investigator Site
Vista, California, 92083
Novartis Investigator Site
Walnut Creek, California, 94598
Novartis Investigator Site
Warrensburg, Missouri, 64093
Novartis Investigator Site
Wheat Ridge, Colorado, 80033
Czechia15 sites
Novartis Investigator Site
Boskovice
Novartis Investigator Site
Břeclav
Novartis Investigator Site
Brno
Novartis Investigator Site
Brno-Bohunice
Novartis Investigator Site
Hradec Králové
Novartis Investigator Site
Jablonec nad Nisou
Novartis Investigator Site
Kladno
Novartis Investigator Site
Kutná Hora
Novartis Investigator Site
Liberec
Novartis Investigator Site
Most
Novartis Investigator Site
Pilsen
Novartis Investigator Site
Prague
Novartis Investigator Site
Tábor
Novartis Investigator Site
Teplice
Novartis Investigative Site
Trutnov
Slovakia11 sites
Novartis Investigator Site
Bardejov
Novartis Investigative Site
Bojnice
Novartis Investigator Site
Bratislava
Novartis Investigator Site
Košice
Novartis Investigator Site
Levice
Novartis Investigator Site
Liptovský Hrádok
Novartis Investigator Site
Michalovce
Novartis Investigative Site
Nitra
Novartis Investigative Site
Šurany
Novartis Investigator Site
Trenčín
Novartis Investigator Site
Vráble
Hungary8 sites
Novartis Investigative Site
Balassagyarmat
Novartis Investigative Site
Debrecen
Novartis Investigator Site
Deszk
Novartis Investigative Site
Győr
Novartis Investigative Site
Mosonmagyaróvár
Novartis Investigative Site
Nyíregyháza
Novartis Investigative Site
Tatabánya
Novartis Investigative Site
Törökbálint
India8 sites
Novartis Investigator Site
Chennai
Novartis Investigator Site
Coimbatore
Novartis Investigator Site
Hyderabaad
Novartis Investigator Site
Indore
Novartis Investigator Site
Mangalore
Novartis Investigator Site
Mumbai
Novartis Investigator Site
Nagpur
Novartis Investigator Site
Panjim
Brazil6 sites
Novartis Investigative Site
Belo Horizonte
Novartis Investigative Site
Florianópolis
Novartis Investigative Site
Porto Alegre
Novartis Investigative Site
Rio de Janeiro
Novartis Investigative Site
Salvador
Novartis Investigative Site
São Paulo
South Korea3 sites
Novartis Investigative Site
Gwangju
Novartis Investigative SIte
Seoul
Novartis Investigator Site
Seoul
Colombia2 sites
Novartis Investigative Site
Barranquilla
Novartis Investigative Site
Bogotá
About this study
Official title: A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma
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.
- Conditions
- Asthma
- Being tested
- QMF149 Twisthaler®, Mometasone Twisthaler®
- Keywords
- Asthma, LABA, Safety
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QMF149 Twisthaler®Drug
Once daily via multi-dose dry-powder inhaler
Mometasone Twisthaler®Drug
Once daily via multi-dose dry-powder inhaler
| Study group | Role | What they receive |
|---|---|---|
| QMF149 Twisthaler® 500/400 | Experimental | QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD) Receives: Drug: QMF149 Twisthaler® |
| Mometasone Twisthaler® | Active comparator | Mometasone Twisthaler®, 400 µg QD Receives: Drug: Mometasone Twisthaler® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 21 months
Secondary outcomes (11)
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.
Measured: up to 21 months
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).
Measured: Up to 21 months
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).
Measured: Up to 21 months
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.
Measured: Baseline to the end of treatment (varying durations, up to 21 months)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline to the end of treatment (varying durations, up to 21 months)
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.
Measured: Baseline to the end of treatment (varying durations, up to 21 months)
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.
Measured: Baseline to the end of treatment (varying durations, up to 21 months)
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.
Measured: Baseline to the end of treatment (varying durations, up to 21 months)
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.
Measured: Baseline to the end of treatment (varying durations, up to 21 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941798
- Sponsor's protocol ID
- CQMF149A2210
- Other IDs
- EudraCT number 2009-011539-10
- Status last verified
- Aug 2012
- First submitted
- 14 Jul 2009
- Last updated
- 31 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma
- ClinicalTrials.gov ID
- NCT00941798
- Acronym / sponsor ID
- CQMF149A2210
- Conditions
- Asthma
- Keywords
- Asthma, LABA, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,283 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Posted 5 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QMF149 Twisthaler® 500/400 | Experimental | Drug: QMF149 Twisthaler®QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD) |
| Mometasone Twisthaler® | Active comparator | Drug: Mometasone Twisthaler®Mometasone Twisthaler®, 400 µg QD |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QMF149 Twisthaler®Once daily via multi-dose dry-powder inhaler | Drug | QMF149 Twisthaler® 500/400 |
| Mometasone Twisthaler®Once daily via multi-dose dry-powder inhaler | Drug | Mometasone Twisthaler® |
Primary outcome
Time to First Serious Asthma Exacerbation
Time frame: Up to 21 months
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.
11 secondary outcomes
Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.
Time frame: up to 21 months
Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids
Time frame: Up to 21 months
Number of Patients With at Least One Asthma Worsening Post-baseline
Time frame: Up to 21 months
Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
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
Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
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
Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit
Time frame: Baseline to the end of treatment (varying durations, up to 21 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25649209Beasley 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.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
146 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QMF149 Twisthaler® and Mometasone Twisthaler® in people with Asthma, run by Novartis Pharmaceuticals at 146 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 146 sites in United States, Czechia, Slovakia, Hungary, India and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Serious Asthma Exacerbation (time frame: Up to 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00941798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2012.