AsthmaPhase 2NCT01502371

A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)

A Phase 2 study testing Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg, Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg and Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg in people with Asthma, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 11 years
Conditions the study is for: Asthma
What is being tested?: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg, Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg and Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 583 participants
Where: No sites listed yet
Study dates: 25 Jan 2012to 29 Jan 2015
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 5 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of asthma of at least 6 months duration.
Using an Inhaled corticosteroid (ICS), either alone or in combination with a long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit and must have been on a stable asthma regimen for at least 2 weeks prior to the Screening Visit, must not have used oral glucocorticosteroids within 30 days of the Screening Visit.

Who cannot join

Treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalization for management of airway obstruction within 3 months prior to the Screening Visit.
History of ventilator support for respiratory failure secondary to asthma.
Upper or lower respiratory tract infection (viral or bacterial) within the 2 weeks prior to Screening and Baseline Visits.
History of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study or require treatment that might interfere with the study. Specific examples include but are not limited to insulin-dependent diabetes, hypertension, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis. Other conditions that are well controlled and stable will not prohibit participation if deemed appropriate per the investigator's judgment.
Inability to correctly use an oral MDI or a DPI.
Participation in this study at another investigational site. Participation in a different investigational study at any site during the same time frame of this study.
Randomization into this study more than once.
Direct association with either the administration of the this study or the study staff.

About this study

Official title: A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3)

The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.

Conditions: Asthma
Being tested: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg, Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg, Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg, Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg, Placebo Metered Dose Inhaler (MDI)
Keywords: Asthma, Children, Persistent
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcgDrug
MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks
Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcgDrug
MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks
Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcgDrug
MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks
Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcgDrug
Also called Asmanex® Twisthaler®
MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks
Placebo Metered Dose Inhaler (MDI)Drug
Placebo MDI, 2 puffs BID for 12 weeks
Placebo Dry Powder Inhaler (DPI)Drug
Placebo DPI, 1 puff QD for 12 weeks

Study groups in NCT01502371
Study group	Role	What they receive
MF MDI 50 mcg BID	Experimental	Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks. Receives: Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg; Drug: Placebo Dry Powder Inhaler (DPI)
MF MDI 100 mcg BID	Experimental	Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. Receives: Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg; Drug: Placebo Dry Powder Inhaler (DPI)
MF MDI 200 mcg BID	Experimental	Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. Receives: Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg; Drug: Placebo Dry Powder Inhaler (DPI)
MF DPI 100 mcg QD	Active comparator	Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks. Receives: Drug: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg; Drug: Placebo Metered Dose Inhaler (MDI)
Placebo	Placebo comparator	Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks. Receives: Drug: Placebo Metered Dose Inhaler (MDI); Drug: Placebo Dry Powder Inhaler (DPI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.
Measured: Baseline and Week 12

Secondary outcomes (3)

Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo
PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups.
Measured: Baseline and Week 12
Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo
The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups.
Measured: Baseline and Week 12
Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 201229 Jan 2015

First posted30 Dec 2011 (estimated)
Study start25 Jan 2012
Primary completion29 Jan 2015
Study completion29 Jan 2015

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 583 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01502371
Sponsor's protocol ID: P04223
Other IDs: 2008-007504-28, MK-0887-086, 2008
Status last verified: Feb 2022
First submitted: 28 Dec 2011
Last updated: 17 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Amar NJ, Shekar T, Varnell TA, Mehta A, Philip G. Mometasone furoate (MF) improves lung function in pediatric asthma: A double-blind, randomized controlled dose-ranging trial of MF metered-dose inhaler. Pediatr Pulmonol. 2017 Mar;52(3):310-318. doi: 10.1002/ppul.23563. Epub 2016 Oct 14.
PubMed 27740721

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3)
ClinicalTrials.gov ID: NCT01502371
Acronym / sponsor ID: P04223
Conditions: Asthma
Keywords: Asthma, Children, Persistent
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 583 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 25 Jan 2012 (actual)
Primary completion: 29 Jan 2015 (actual)
Study completion: 29 Jan 2015 (actual)
First posted: 30 Dec 2011 (estimated)
Results: Posted 6 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
MF MDI 50 mcg BID	Experimental	Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg, Drug: Placebo Dry Powder Inhaler (DPI)Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
MF MDI 100 mcg BID	Experimental	Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg, Drug: Placebo Dry Powder Inhaler (DPI)Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
MF MDI 200 mcg BID	Experimental	Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg, Drug: Placebo Dry Powder Inhaler (DPI)Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
MF DPI 100 mcg QD	Active comparator	Drug: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg, Drug: Placebo Metered Dose Inhaler (MDI)Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
Placebo	Placebo comparator	Drug: Placebo Metered Dose Inhaler (MDI), Drug: Placebo Dry Powder Inhaler (DPI)Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.

Who may qualify

Ages: 5 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Diagnosis of asthma of at least 6 months duration.
Using an Inhaled corticosteroid (ICS), either alone or in combination with a long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit and must have been on a stable asthma regimen for at least 2 weeks prior to the Screening Visit, must not have used oral glucocorticosteroids within 30 days of the Screening Visit.

Key exclusion criteria (8 listed)

Treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalization for management of airway obstruction within 3 months prior to the Screening Visit.
History of ventilator support for respiratory failure secondary to asthma.
Upper or lower respiratory tract infection (viral or bacterial) within the 2 weeks prior to Screening and Baseline Visits.
History of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study or require treatment that might interfere with the study. Specific examples include but are not limited to insulin-dependent diabetes, hypertension, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis. Other conditions that are well controlled and stable will not prohibit participation if deemed appropriate per the investigator's judgment.
Inability to correctly use an oral MDI or a DPI.

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
Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcgMF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks	Drug	MF MDI 50 mcg BID
Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcgMF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks	Drug	MF MDI 100 mcg BID
Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcgMF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks	Drug	MF MDI 200 mcg BID
Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcgAlso: Asmanex® Twisthaler®MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks	Drug	MF DPI 100 mcg QD
Placebo Metered Dose Inhaler (MDI)Placebo MDI, 2 puffs BID for 12 weeks	Drug	MF DPI 100 mcg QD, Placebo
Placebo Dry Powder Inhaler (DPI)Placebo DPI, 1 puff QD for 12 weeks	Drug	MF MDI 100 mcg BID, MF MDI 200 mcg BID, MF MDI 50 mcg BID, Placebo

Primary outcome

Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo
Time frame: Baseline and Week 12
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.

3 secondary outcomes

Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo
Time frame: Baseline and Week 12
Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo
Time frame: Baseline and Week 12
Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 6 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MF MDI 50 mcg BID	120	79
MF MDI 100 mcg BID	113	81
MF MDI 200 mcg BID	108	83
MF DPI 100 mcg QD	125	88
Placebo	112	60

Primary outcome: Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo

Time frame: Baseline and Week 12. Least squares mean (95% Confidence Interval). Unit: Percentage of Predicted FEV1

Measure	MF MDI 50 mcg BID n = 114	MF MDI 100 mcg BID n = 109	MF MDI 200 mcg BID n = 105	Placebo n = 111
Value	4.52 (2.32 to 6.72)	6.95 (4.73 to 9.16)	6.00 (3.74 to 8.25)	0.66 (-1.72 to 3.03)

MF MDI 50 mcg BID vs Placebo: Mean Difference (Net): 3.87 (95% CI 0.64 to 7.09), p = 0.019, cLDA model
MF MDI 100 mcg BID vs Placebo: Mean Difference (Net): 6.29 (95% CI 3.05 to 9.53), p <0.001, cLDA
MF MDI 200 mcg BID vs Placebo: Mean Difference (Net): 5.34 (95% CI 2.07 to 8.61), p = 0.001, cLDA

Population analysed: The Full Analysis Set (FAS) population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI or Placebo were included in this primary analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MF MDI 50 mcg BID	2 of 120 (1.7%)	19 of 120 (15.8%)	Not reported
MF MDI 100 mcg BID	1 of 113 (0.9%)	18 of 113 (15.9%)	Not reported
MF MDI 200 mcg BID	2 of 108 (1.9%)	18 of 108 (16.7%)	Not reported
MF DPI 100 mcg QD	4 of 125 (3.2%)	16 of 125 (12.8%)	Not reported
Placebo	2 of 112 (1.8%)	19 of 112 (17%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27740721Amar NJ, Shekar T, Varnell TA, Mehta A, Philip G. Mometasone furoate (MF) improves lung function in pediatric asthma: A double-blind, randomized controlled dose-ranging trial of MF metered-dose inhaler. Pediatr Pulmonol. 2017 Mar;52(3):310-318. doi: 10.1002/ppul.23563. Epub 2016 Oct 14.
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?

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 2 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 17 Jun 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. Some participants in this study may receive a placebo. 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 6 Oct 2015). 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 Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo (time frame: Baseline and Week 12). 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 NCT01502371, 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 17 Jun 2024.