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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01502371
Recruitment Status : Completed
First Posted : December 30, 2011
Results First Posted : October 6, 2015
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg Drug: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg Drug: Placebo Metered Dose Inhaler (MDI) Drug: Placebo Dry Powder Inhaler (DPI) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 583 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 25, 2012
Actual Primary Completion Date : January 29, 2015
Actual Study Completion Date : January 29, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 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.
Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg
MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks

Drug: Placebo Dry Powder Inhaler (DPI)
Placebo DPI, 1 puff QD for 12 weeks

Experimental: 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.
Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg
MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks

Drug: Placebo Dry Powder Inhaler (DPI)
Placebo DPI, 1 puff QD for 12 weeks

Experimental: 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.
Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg
MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks

Drug: Placebo Dry Powder Inhaler (DPI)
Placebo DPI, 1 puff QD for 12 weeks

Active Comparator: 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.
Drug: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg
MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks
Other Name: Asmanex® Twisthaler®

Drug: Placebo Metered Dose Inhaler (MDI)
Placebo MDI, 2 puffs BID for 12 weeks

Placebo Comparator: Placebo
Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
Drug: Placebo Metered Dose Inhaler (MDI)
Placebo MDI, 2 puffs BID for 12 weeks

Drug: Placebo Dry Powder Inhaler (DPI)
Placebo DPI, 1 puff QD for 12 weeks




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo [ Time Frame: Baseline and Week 12 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502371


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT01502371    
Other Study ID Numbers: P04223
2008-007504-28 ( EudraCT Number )
MK-0887-086 ( Other Identifier: Merck )
First Posted: December 30, 2011    Key Record Dates
Results First Posted: October 6, 2015
Last Update Posted: February 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Keywords provided by Organon and Co:
Asthma
Children
Persistent
Additional relevant MeSH terms:
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Mometasone Furoate
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents