AsthmaPhase 3NCT02741271
Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination With Formoterol Fumarate Versus Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)
A Phase 3 study testing MF MDI 100 mcg BID (Open Label), MF/F MDI 100/10 mcg BID and MF MDI 100 mcg BID in people with Asthma, run by Organon and Co.
Trial summary
This study compares the 12-week efficacy and 24-week safety of mometasone furoate/formoterol fumarate (MF/F) 100/10 mcg and mometasone furate (MF) 100 mcg, both administered twice daily (BID) via metered-dose inhaler (MDI) in children aged 5 to 11 years with persistent asthma. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- MF MDI 100 mcg BID (Open Label), MF/F MDI 100/10 mcg BID and MF MDI 100 mcg BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2016to 4 Dec 2017
- Phase
- Phase 3
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines
- Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks
- Is able to demonstrate an FEV1 >60% and ≤90% predicted
- Is able to demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol/salbutamol.
- Is able to use an MDI (without spacer), use a peak flow meter, and perform spirometry correctly.
- Is willing (with consent of their parent(s)/guardian) to discontinue previously prescribed asthma medication, if there is no inherent harm in changing the participant's current asthma therapy.
- Has laboratory tests that are clinically acceptable to the investigator.
Who cannot join
- Requires >8 inhalations per day of albuterol (100 mcg per actuation), and/or >2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days
- Has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) between the Screening and Baseline visits.
- Is considered by the investigator to have unstable asthma at the end of the run-in period
- Has had > 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1
- Has had a history of life-threatening asthma
- Has a clinically significant condition or situation, other than the condition being studied which may interfere with trial evaluations, participant safety, or optimal participation in the trial
About this study
Official title: A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Children With Persistent Asthma
This study compares the 12-week efficacy and 24-week safety of mometasone furoate/formoterol fumarate (MF/F) 100/10 mcg and mometasone furate (MF) 100 mcg, both administered twice daily (BID) via metered-dose inhaler (MDI) in children aged 5 to 11 years with persistent asthma.
- Conditions
- Asthma
- Being tested
- MF MDI 100 mcg BID (Open Label), MF/F MDI 100/10 mcg BID, MF MDI 100 mcg BID, Albuterol/Salbutamol PRN, Prednisone/Prednisolone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF MDI 100 mcg BID (Open Label)Drug
Also called ASMANEX HFA®, SCH 032088 (MK-0887)
Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.
MF/F MDI 100/10 mcg BIDDrug
Also called DULERA®/ZENHALE®, SCH 418131 (MK-0887A)
After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF/F MDI 100/10 mcg BID.
MF MDI 100 mcg BIDDrug
Also called ASMANEX HFA®, SCH 032088 (MK-0887)
After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF MDI 100 mcg BID.
Albuterol/Salbutamol PRNDrug
Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms.
Prednisone/PrednisoloneDrug
Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion.
| Study group | Role | What they receive |
|---|---|---|
| MF/F MDI 100/10 mcg BID | Experimental | Eligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks. Receives: Drug: MF MDI 100 mcg BID (Open Label); Drug: MF/F MDI 100/10 mcg BID; Drug: Albuterol/Salbutamol PRN; Drug: Prednisone/Prednisolone |
| MF MDI 100 mcg BID | Active comparator | Eligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks. Receives: Drug: MF MDI 100 mcg BID (Open Label); Drug: MF MDI 100 mcg BID; Drug: Albuterol/Salbutamol PRN; Drug: Prednisone/Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.
Measured: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12
Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.
Measured: Up to 26 weeks
Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.
Measured: Up to 24 weeks
Secondary outcomes (10)
Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment
The key secondary objective was to determine the onset of action for the efficacy of MF/F MDI 100/10 mcg BID, compared with MF MDI 100 mcg BID. The post-dose AM % predicted FEV1 was averaged sequentially, and the change from baseline on Day 1 was assessed. This key secondary endpoint was controlled for multiplicity in a step-down fashion, based on trial success defined as a statistically significant improvement in the primary endpoint for MF/F vs MF. Missing data were imputed using control-based multiple imputations with the cLDA model.
Measured: Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points
Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 4 hours post-dose on Day 1 and Week 12 compared to Baseline. Baseline was the average of 30 and 0 minutes pre-dose % predicted FEV1 values. The AUC was calculated over the scheduled timepoints of 0 min, 5 min, 15 min, 30 min, 60 min, 2 hr and 4 hr post-dose. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.
Measured: Baseline, Day 1 and Week 12
Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
The change from baseline in AM pre-dose % predicted FEV1 with MF/F MDI 100/10 mcg BID vs MF MDI 100 mcg BID averaged over 12 weeks treatment was assessed. This secondary analysis of the change from baseline used the cLDA method without multiple imputation. A model-based MAR approach was used for missing data.
Measured: Baseline and Weeks 4, 8, and 12 (Averaged)
Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the change from baseline in total daily short-acting beta-agonist (SABA) use (puffs per day) was averaged and assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms. This secondary analysis of the change from baseline used the cLDA method without multiple imputation.A model-based MAR approach was used for missing data.
Measured: Baseline and Weeks 1-12 (Averaged)
Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants using SABA rescue medication in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms.
Measured: Baseline and Weeks 1-12 (Averaged)
Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants whose use of SABA rescue medication increased in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for relief of asthma symptoms.
Measured: Weeks 1-12 (Averaged)
Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12)
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.
Measured: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last)
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.
Measured: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Maximum Plasma Concentration (Cmax) of Mometsone Furoate
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.
Measured: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.
Measured: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start11 May 2016
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741271
- Sponsor's protocol ID
- 0887A-087
- Other IDs
- MK-0887A-087, 2009-010110-30, 2009
- Status last verified
- Feb 2022
- First submitted
- 13 Apr 2016
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weinstein CLJ, Gates D, Zhang X, Varnell T, Mok W, Vermeulen JH, Amar NJ, Jain N. A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma. Pediatr Pulmonol. 2020 Apr;55(4):882-889. doi: 10.1002/ppul.24667. Epub 2020 Feb 5.
PubMed 32022483
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Children With Persistent Asthma
- ClinicalTrials.gov ID
- NCT02741271
- Acronym / sponsor ID
- 0887A-087
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Posted 22 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the 12-week efficacy and 24-week safety of mometasone furoate/formoterol fumarate (MF/F) 100/10 mcg and mometasone furate (MF) 100 mcg, both administered twice daily (BID) via metered-dose inhaler (MDI) in children aged 5 to 11 years with persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MF/F MDI 100/10 mcg BID | Experimental | Drug: MF MDI 100 mcg BID (Open Label), Drug: MF/F MDI 100/10 mcg BID, Drug: Albuterol/Salbutamol PRN, Drug: Prednisone/PrednisoloneEligible participants will be assigned randomly to receive double-blinded MF/F MDI 100/10 mcg BID for 24 weeks. |
| MF MDI 100 mcg BID | Active comparator | Drug: MF MDI 100 mcg BID (Open Label), Drug: MF MDI 100 mcg BID, Drug: Albuterol/Salbutamol PRN, Drug: Prednisone/PrednisoloneEligible participants will be assigned randomly to receive double-blinded MF MDI 100 mcg BID for 24 weeks. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Has a diagnosis of asthma of ≥ 6-months duration according to the Global Initiative for Asthma (GINA) guidelines
- Has asthma that is adequately controlled on a stable dose of inhaled corticosteroid (ICS) combined with long-acting beta-agonist (LABA) ≥ 4 weeks
- Is able to demonstrate an FEV1 >60% and ≤90% predicted
- Is able to demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of albuterol/salbutamol.
- Is able to use an MDI (without spacer), use a peak flow meter, and perform spirometry correctly.
Key exclusion criteria (6 listed)
- Requires >8 inhalations per day of albuterol (100 mcg per actuation), and/or >2 nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days
- Has a clinical worsening of asthma that results in emergency room visit (for an asthma exacerbation), hospitalization due to asthma, or treatment with additional, excluded asthma medication (other than SABA) between the Screening and Baseline visits.
- Is considered by the investigator to have unstable asthma at the end of the run-in period
- Has had > 4 asthma exacerbations (defined as a worsening of asthma requiring systemic corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care center, or hospital) within 1 year prior to visit 1
- Has had a history of life-threatening asthma
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 |
|---|---|---|
| MF MDI 100 mcg BID (Open Label)Also: ASMANEX HFA®, SCH 032088 (MK-0887)Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period. | Drug | MF MDI 100 mcg BID, MF/F MDI 100/10 mcg BID |
| MF/F MDI 100/10 mcg BIDAlso: DULERA®/ZENHALE®, SCH 418131 (MK-0887A)After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF/F MDI 100/10 mcg BID. | Drug | MF/F MDI 100/10 mcg BID |
| MF MDI 100 mcg BIDAlso: ASMANEX HFA®, SCH 032088 (MK-0887)After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF MDI 100 mcg BID. | Drug | MF MDI 100 mcg BID |
| Albuterol/Salbutamol PRNParticipants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms. | Drug | MF MDI 100 mcg BID, MF/F MDI 100/10 mcg BID |
| Prednisone/PrednisoloneParticipants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion. | Drug | MF MDI 100 mcg BID, MF/F MDI 100/10 mcg BID |
Primary outcome
Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60
Time frame: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.
Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)
Time frame: Up to 26 weeks
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.
Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE
Time frame: Up to 24 weeks
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.
10 secondary outcomes
Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment
Time frame: Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points
Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment
Time frame: Baseline, Day 1 and Week 12
Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
Time frame: Baseline and Weeks 4, 8, and 12 (Averaged)
Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
Time frame: Baseline and Weeks 1-12 (Averaged)
Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period
Time frame: Baseline and Weeks 1-12 (Averaged)
Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period
Time frame: Weeks 1-12 (Averaged)
Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12)
Time frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last)
Time frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Maximum Plasma Concentration (Cmax) of Mometsone Furoate
Time frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate
Time frame: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32022483Weinstein CLJ, Gates D, Zhang X, Varnell T, Mok W, Vermeulen JH, Amar NJ, Jain N. A phase 3 study evaluating the safety and efficacy of a pediatric dose of mometasone furoate with and without formoterol for persistent asthma. Pediatr Pulmonol. 2020 Apr;55(4):882-889. doi: 10.1002/ppul.24667. Epub 2020 Feb 5.
- Individual participant dataSharing planned: No
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MF MDI 100 mcg BID (Open Label), MF/F MDI 100/10 mcg BID and MF MDI 100 mcg BID in people with Asthma, run by Organon and Co.
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 7 inclusion and 6 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 May 2019). 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?
Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60 (time frame: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12). The study lists 3 primary outcomes in all. 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 NCT02741271, 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 16 May 2024.