A Phase 4 interventional study of Mometasone Furoate/Formoterol MDI 100/5 mcg and Mometasone Furoate/Formoterol MDI 200/5 mcg in Asthma, sponsored by Organon and Co. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Organon and Co · Phase 4, Interventional, and Treatment
The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.
Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 11,744 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MF/F MDI BID (pooled MF/F MDI 200/10 mcg BID and MF/F MDI 400/10 mcg BID treatments)
Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg · Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg · Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI · Drug: Prednisone/prednisolone
MF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments)
Drug: Mometasone Furoate MDI 100 mcg · Drug: Mometasone Furoate MDI 200 mcg · Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI · Drug: Prednisone/prednisolone
two inhalations BID
Also known as: MK-0887A; Dulera/Zenhale
two inhalations BID
Also known as: MK-0887A; Dulera/Zenhale
two inhalations BID
Also known as: Asmanex
two inhalations BID
Also known as: Asmanex
use as needed for asthma symptoms
Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator
Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms
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.
Time frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms
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.
Time frame: 26 weeks, plus 7 days after the last treatment
Number of SAO Components in MF/F Participants vs MF Participants
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.
Time frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
11,744 participants were enrolled in the study and 11,729 participants were randomized and received at least one dose of blinded study treatment (defined as the number started). Treatments were Mometasone Furoate/Formoterol (MF/F) metered dose inhaler (MDI) twice daily (BID) and Mometasone Furoate (MF) MDI BID.
| Milestone | Mometasone Furoate/Formoterol (MF/F) MDI BID | Mometasone Furoate (MF) MDI BID |
|---|---|---|
| Started | 5868 | 5861 |
| Completed | 5862 | 5855 |
| Not completed | 6 | 6 |
| Withdrew: Death | 5 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Investigational site closure | 0 | 1 |
| Withdrew: Invalid informed consent | 1 | 0 |
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.
| Serious asthma outcomes | MF/F MDI BID | MF MDI BID |
|---|---|---|
| Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms | 39 | 32 |
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.
| Asthma exacerbations | MF/F MDI BID | MF MDI BID |
|---|---|---|
| Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms | 708 | 779 |
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.
| SAO components | MF/F MDI BID | MF MDI BID |
|---|---|---|
| First SAO | 39 | 32 |
| Asthma-related hospitalizations | 39 | 32 |
| Asthma-related intubations | 0 | 0 |
| Asthma-related deaths | 0 | 0 |
Collected over 26 weeks, or 7 days after the last treatment dose, whichever occurred later. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MF/F MDI BID | 5/5,868 (0.1%) | 136/5,868 (2.3%) | 67/5,868 (1.1%) |
| MF MDI BID | 4/5,861 (0.1%) | 137/5,861 (2.3%) | 75/5,861 (1.3%) |
| Event | MF/F MDI BID | MF MDI BID |
|---|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 32/5868 | 31/5861 |
| PneumoniaInfections and infestations | 10/5868 | 6/5861 |
| AppendicitisInfections and infestations | 6/5868 | 4/5861 |
| Ankle fractureInjury, poisoning and procedural complications | 1/5868 | 4/5861 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 3/5868 | 4/5861 |
| Tibia fractureInjury, poisoning and procedural complications | 2/5868 | 3/5861 |
| Cardiac failureCardiac disorders | 3/5868 | 0/5861 |
| BronchitisInfections and infestations | 3/5868 | 0/5861 |
| DiverticulitisInfections and infestations | 3/5868 | 0/5861 |
| HypertensionVascular disorders | 3/5868 | 1/5861 |
| Event | MF/F MDI BID | MF MDI BID |
|---|---|---|
| HeadacheNervous system disorders | 3/5868 | 7/5861 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/5868 | 6/5861 |
| DysphoniaRespiratory, thoracic and mediastinal disorders | 4/5868 | 5/5861 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 4/5868 | 5/5861 |
| Chest discomfortGeneral disorders | 1/5868 | 3/5861 |
| StomatitisGastrointestinal disorders | 2/5868 | 3/5861 |
| WheezingRespiratory, thoracic and mediastinal disorders | 0/5868 | 3/5861 |
| Upper respiratory tract infectionInfections and infestations | 0/5868 | 3/5861 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 3/5868 | 1/5861 |
| Dry mouthGastrointestinal disorders | 3/5868 | 0/5861 |
These are all participants who were randomized and treated with at least one dose of study medication
| Age, Continuous(Years) | Mometasone Furoate/Formoterol (MF/F) MDI BID | Mometasone Furoate (MF) MDI BID | Total |
|---|---|---|---|
| Mean | 45.3 ± 17.19 | 44.8 ± 17.55 | 45.1 ± 17.37 |
| Sex: Female, Male(Participants) | Mometasone Furoate/Formoterol (MF/F) MDI BID | Mometasone Furoate (MF) MDI BID | Total |
|---|---|---|---|
| Female | 3841 | 3875 | 7716 |
| Male | 2027 | 1986 | 4013 |
| Treatment Covariates (MF/F or MF) and ICS Dose Level (100 or 200 mcg, per actuation)(Participants) | Mometasone Furoate/Formoterol (MF/F) MDI BID | Mometasone Furoate (MF) MDI BID | Total |
|---|---|---|---|
| MF/F 200/10 mcg | 3604 | 0 | 3604 |
| MF/F 400/10 mcg | 2264 | 0 | 2264 |
| MF 200 mcg | 0 | 3601 | 3601 |
| MF 400 mcg | 0 | 2260 | 2260 |
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Organon and Co