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

NCT ID: NCT01502371

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 583 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-25
• Study Completion Date: 2015-01-29

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MF MDI 50 mcg BID

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.

Group Type: EXPERIMENTAL

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg

Intervention Type: DRUG

MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks

Placebo Dry Powder Inhaler (DPI)

Intervention Type: DRUG

Placebo DPI, 1 puff QD for 12 weeks

MF MDI 100 mcg BID

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.

Group Type: EXPERIMENTAL

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg

Intervention Type: DRUG

MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks

Placebo Dry Powder Inhaler (DPI)

Intervention Type: DRUG

Placebo DPI, 1 puff QD for 12 weeks

MF MDI 200 mcg BID

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.

Group Type: EXPERIMENTAL

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg

Intervention Type: DRUG

MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks

Placebo Dry Powder Inhaler (DPI)

Intervention Type: DRUG

Placebo DPI, 1 puff QD for 12 weeks

MF DPI 100 mcg QD

Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg

Intervention Type: DRUG

MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks

Placebo Metered Dose Inhaler (MDI)

Intervention Type: DRUG

Placebo MDI, 2 puffs BID for 12 weeks

Placebo

Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Metered Dose Inhaler (MDI)

Intervention Type: DRUG

Placebo MDI, 2 puffs BID for 12 weeks

Placebo Dry Powder Inhaler (DPI)

Intervention Type: DRUG

Placebo DPI, 1 puff QD for 12 weeks

Interventions

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg

MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks

Intervention Type: DRUG

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg

MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks

Intervention Type: DRUG

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg

MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks

Intervention Type: DRUG

Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg

MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks

Intervention Type: DRUG

Placebo Metered Dose Inhaler (MDI)

Placebo MDI, 2 puffs BID for 12 weeks

Intervention Type: DRUG

Placebo Dry Powder Inhaler (DPI)

Placebo DPI, 1 puff QD for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Asmanex® Twisthaler®

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 27740721 (View on PubMed)

Other Identifiers

2008-007504-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-0887-086

Identifier Type: OTHER

Identifier Source: secondary_id

P04223

Identifier Type: -

Identifier Source: org_study_id