Trial · NCT01471340
A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)
NCT01471340, Phase 4, Completed, Organon and Co; results first posted 2018-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241). Trials, record NCT01471340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01471340
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)
- NCT number
- NCT01471340
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 11,744 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Asthma
- Interventions
Mometasone Furoate/Formoterol MDI 100/5 mcg, Mometasone Furoate/Formoterol MDI 200/5 mcg, Mometasone Furoate MDI 100 mcg, Mometasone Furoate MDI 200 mcg, Albuterol 90 mcg /salbutamol 100 mcg HFA MDI, Prednisone/prednisolone
- First posted
- 2011-11-16
- Last updated
- 2024-05-23
- Other registries' IDs
- eudract:2011-002142-13
- Results first posted
- 2018-01-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms | 26 weeks, or 7 days after the last treatment dose, whichever occurred later | The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant. |
| Secondary | Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms | 26 weeks, plus 7 days after the last treatment | The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for \>= 3 consecutive days, in-patient hospitalization \>= 24 hours, or an emergency department (ED) visit \< 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant. |
| Other | Number of SAO Components in MF/F Participants vs MF Participants | 26 weeks, or 7 days after the last treatment dose, whichever occurred later | To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of \>= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only. |
Source ClinicalTrials.gov
Outcomes3
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 Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms | 26 weeks, or 7 days after the last treatment dose, whichever occurred later | The analyzed population for assessment of the number of first SAO was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle). | Serious asthma outcomes | NUMBER |
| SECONDARY | Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms | 26 weeks, plus 7 days after the last treatment | The analyzed population for assessment of the number of first asthma exacerbations was all treated participants who received at least one dose of randomized treatment assignment (intention-to-treat principle). | Asthma exacerbations | NUMBER |
| OTHER_PRE_SPECIFIED | Number of SAO Components in MF/F Participants vs MF Participants | 26 weeks, or 7 days after the last treatment dose, whichever occurred later | The analyzed population for tabulation of the number of SAO components was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle). | SAO components | NUMBER |
Source ClinicalTrials.gov
Results by group12
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 Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms | MF/F MDI BID | 39 | Serious asthma outcomes | ||
| Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms | MF MDI BID | 32 | Serious asthma outcomes | ||
| Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms | MF/F MDI BID | 708 | Asthma exacerbations | ||
| Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms | MF MDI BID | 779 | Asthma exacerbations | ||
| Number of SAO Components in MF/F Participants vs MF Participants | MF/F MDI BID | First SAO | 39 | SAO components | |
| Number of SAO Components in MF/F Participants vs MF Participants | MF MDI BID | First SAO | 32 | SAO components | |
| Number of SAO Components in MF/F Participants vs MF Participants | MF/F MDI BID | Asthma-related hospitalizations | 39 | SAO components | |
| Number of SAO Components in MF/F Participants vs MF Participants | MF MDI BID | Asthma-related hospitalizations | 32 | SAO components | |
| Number of SAO Components in MF/F Participants vs MF Participants | MF/F MDI BID | Asthma-related intubations | 0 | SAO components | |
| Number of SAO Components in MF/F Participants vs MF Participants | MF MDI BID | Asthma-related intubations | 0 | SAO components |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mometasone Furoate/Formoterol (MF/F) MDI BID | 5,868 | |
| Overall Study | STARTED | Mometasone Furoate (MF) MDI BID | 5,861 | |
| Overall Study | COMPLETED | Mometasone Furoate/Formoterol (MF/F) MDI BID | 5,862 | |
| Overall Study | COMPLETED | Mometasone Furoate (MF) MDI BID | 5,855 | |
| Overall Study | NOT COMPLETED | Mometasone Furoate/Formoterol (MF/F) MDI BID | 6 | |
| Overall Study | NOT COMPLETED | Mometasone Furoate (MF) MDI BID | 6 |
Source ClinicalTrials.gov
Adverse events498
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 | Angina pectoris | Cardiac disorders | MF/F MDI BID | 0 | 5,868 | 0 |
| other | Angina pectoris | Cardiac disorders | MF MDI BID | 1 | 5,861 | 1 |
| other | Arrhythmia | Cardiac disorders | MF/F MDI BID | 0 | 5,868 | 0 |
| other | Arrhythmia | Cardiac disorders | MF MDI BID | 1 | 5,861 | 1 |
| other | Atrial fibrillation | Cardiac disorders | MF/F MDI BID | 1 | 5,868 | 1 |
| other | Atrial fibrillation | Cardiac disorders | MF MDI BID | 0 | 5,861 | 0 |
| other | Hypertension | Vascular disorders | MF/F MDI BID | 0 | 5,868 | 0 |
| other | Hypertension | Vascular disorders | MF MDI BID | 1 | 5,861 | 1 |
| other | Heart rate increased | Investigations | MF/F MDI BID | 1 | 5,868 | 1 |
| other | Heart rate increased | Investigations | MF MDI BID | 0 | 5,861 | 0 |
1 to 10 of 498Source ClinicalTrials.gov
See all 498 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MF/F MDI BID | 5 | 5,868 |
| Total, all-cause mortality | MF MDI BID | 4 | 5,861 |
| Total, other adverse events | MF/F MDI BID | 67 | 5,868 |
| Total, other adverse events | MF MDI BID | 75 | 5,861 |
| Total, serious adverse events | MF/F MDI BID | 136 | 5,868 |
| Total, serious adverse events | MF MDI BID | 137 | 5,861 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MF/F MDI BID vs MF MDI BID: deaths from any cause | Trial comparisons |
| MF/F MDI BID vs MF MDI BID: 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01471340
GET https://conductscience.org/api/trials/v1/NCT01471340/events?page=2