Trial · NCT00941798
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
NCT00941798, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2012-06-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma. Trials, record NCT00941798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00941798
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
- NCT number
- NCT00941798
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 2,283 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Asthma
- Interventions
- QMF149 Twisthaler®, Mometasone Twisthaler®
- First posted
- 2009-07-20
- Last updated
- 2012-08-31
- Other registries' IDs
- eudract:2009-011539-10
- Results first posted
- 2012-06-05
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Serious Asthma Exacerbation | 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. |
| Secondary | Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. | up to 21 months | 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. |
| Secondary | Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids | Up to 21 months | Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months). |
| Secondary | Number of Patients With at Least One Asthma Worsening Post-baseline | Up to 21 months | 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). |
| Secondary | Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit | Baseline to the end of treatment (varying durations, up to 21 months) | 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. |
| Secondary | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 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 | 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. |
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 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 | 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. |
| Secondary | Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period | Baseline to the end of treatment (varying durations, up to 21 months) | 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. |
| Secondary | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Baseline to the end of treatment (varying durations, up to 21 months) | 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. |
| Secondary | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Baseline to the end of treatment (varying durations, up to 21 months) | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Serious Asthma Exacerbation | Up to 21 months | Full analysis set: all randomized patients who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. | up to 21 months | Full analysis set: all randomized patients who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids | Up to 21 months | Full analysis set: all randomized patients who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Patients With at Least One Asthma Worsening Post-baseline | Up to 21 months | Full analysis set: all randomized patients who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit | Baseline to the end of treatment (varying durations, up to 21 months) | Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis. | liters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit | 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 | Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis. | liters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit | 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 | Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis. | liter | LEAST_SQUARES_MEAN |
| SECONDARY | Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period | Baseline to the end of treatment (varying durations, up to 21 months) | Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and at final visit were included in this analysis. | liters per second | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime | Baseline to the end of treatment (varying durations, up to 21 months) | Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and final visit were included in this analysis. | percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime | Baseline to the end of treatment (varying durations, up to 21 months) | Full analysis set: all randomized patients who received at least one dose of study medication. Participants with observations at both baseline and endpoint were included in this analysis. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Serious Asthma Exacerbation | QMF149 Twisthaler® 500/400 | 13.3 | Full Range 0.0 to 19.6 | months | |
| Time to First Serious Asthma Exacerbation | Mometasone Twisthaler® | 13.4 | Full Range 0.0 to 20.3 | months | |
| Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. | QMF149 Twisthaler® 500/400 | 2 | participants | ||
| Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. | Mometasone Twisthaler® | 6 | participants | ||
| Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids | QMF149 Twisthaler® 500/400 | 124 | participants | ||
| Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids | Mometasone Twisthaler® | 171 | participants | ||
| Number of Patients With at Least One Asthma Worsening Post-baseline | QMF149 Twisthaler® 500/400 | 533 | participants | ||
| Number of Patients With at Least One Asthma Worsening Post-baseline | Mometasone Twisthaler® | 637 | participants | ||
| Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit | QMF149 Twisthaler® 500/400 | 0.06 | Standard Error 0.025 | liters | |
| Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit | Mometasone Twisthaler® | -0.07 | Standard Error 0.024 | liters |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QMF149 Twisthaler® 500/400 | 755 | |
| Overall Study | STARTED | Mometasone Twisthaler® | 763 | |
| Overall Study | Full Analysis Set | QMF149 Twisthaler® 500/400 | 749 | |
| Overall Study | Full Analysis Set | Mometasone Twisthaler® | 759 | |
| Overall Study | COMPLETED | QMF149 Twisthaler® 500/400 | 561 | |
| Overall Study | COMPLETED | Mometasone Twisthaler® | 578 | |
| Overall Study | NOT COMPLETED | QMF149 Twisthaler® 500/400 | 194 | |
| Overall Study | NOT COMPLETED | Mometasone Twisthaler® | 185 |
Source ClinicalTrials.gov
Adverse events202
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | QMF149 Twisthaler® 500/400 | 12 | 749 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Mometasone Twisthaler® | 8 | 759 | |
| other | Pyrexia | General disorders | QMF149 Twisthaler® 500/400 | 9 | 749 | |
| other | Pyrexia | General disorders | Mometasone Twisthaler® | 14 | 759 | |
| other | Acute sinusitis | Infections and infestations | QMF149 Twisthaler® 500/400 | 16 | 749 | |
| other | Acute sinusitis | Infections and infestations | Mometasone Twisthaler® | 8 | 759 | |
| other | Bronchitis | Infections and infestations | QMF149 Twisthaler® 500/400 | 39 | 749 | |
| other | Bronchitis | Infections and infestations | Mometasone Twisthaler® | 58 | 759 | |
| other | Influenza | Infections and infestations | QMF149 Twisthaler® 500/400 | 26 | 749 | |
| other | Influenza | Infections and infestations | Mometasone Twisthaler® | 27 | 759 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QMF149 Twisthaler® 500/400 | ||
| Total, all-cause mortality | Mometasone Twisthaler® | ||
| Total, other adverse events | QMF149 Twisthaler® 500/400 | 510 | 749 |
| Total, other adverse events | Mometasone Twisthaler® | 477 | 759 |
| Total, serious adverse events | QMF149 Twisthaler® 500/400 | 30 | 749 |
| Total, serious adverse events | Mometasone Twisthaler® | 44 | 759 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25649209 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| QMF149 Twisthaler® 500/400 vs Mometasone Twisthaler®: Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids | Trial comparisons |
| QMF149 Twisthaler® 500/400 vs Mometasone Twisthaler®: Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. | Trial comparisons |
| QMF149 Twisthaler® 500/400 vs Mometasone Twisthaler®: Number of Patients With at Least One Asthma Worsening Post-baseline | Trial comparisons |
| QMF149 Twisthaler® 500/400 vs Mometasone Twisthaler®: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT00941798/results?page=2