Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)

February 7, 2022 updated by: Organon and Co

A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and Beclomethasone Dipropionate (BDP HFA) on the HPA Axis in Asthmatic Children 5 to 11 Years of Age (Protocol No. P05574/PN158)

The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of persistent asthma of ≥6 months duration
  • body weight ≥18 kg
  • able to discontinue prescribed inhaled corticosteroid (ICS) or ICS combined with long-acting beta-agonist (LABA) before starting study medication
  • use of a low or medium daily dose of ICS (either alone or in combination with a LABA) with no use of oral corticosteroids within 3 months prior to Screening Visit
  • stable asthma regimen (daily dose unchanged) for ≥2 weeks prior to Screening Visit
  • documented positive responsiveness to bronchodilators
  • ability to use a peak flow meter correctly and to perform spirometry and PEF measurements
  • ability to use an inhaler correctly
  • consent/assent for the trial and for pharmacogenetic testing (Note: If unwilling to consent/assent for pharmacogenetic testing, inclusion in the study is still allowed, but no pharmacogenetic samples will be obtained.)

Exclusion Criteria:

  • use of a high dose of ICS for ≥30 days within 6 months prior to Screening Visit
  • treatment in the emergency room (for a severe asthma exacerbation requiring systemic corticosteroid treatment) or hospitalization for management of airway obstruction within 3 months prior to Screening Visit
  • ever required ventilator support for respiratory failure secondary to asthma
  • upper or lower respiratory tract infection (viral or bacterial) within 2 weeks prior to Screening Visit
  • clinically significant abnormal vital sign
  • evidence of oropharyngeal candidiasis
  • history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder that may interfere with study participation. Specific examples include but are not limited to insulin-dependent diabetes, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis
  • allergy to or intolerance of corticoids, beta-2 agonists, montelukast or any of the inactive ingredients in the medications used in this study
  • participation in this same study at another study site
  • previous randomization into this study
  • participation in another investigational study for the duration of this study
  • use of any investigational drug within one month prior to Screening Visit
  • previous participation in a study with MF/F or montelukast
  • direct association with or family member of one of the investigators or study staff
  • sibling of a participant in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: MF/F MDI 200/10 mcg BID
Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Drug: Rescue medication: Prednisone/Prednisolone
Prednisone/Prednisolone for rescue medication, taken as directed
Drug: MF/F MDI 100/5 mcg
MF/F MDI 100/5 mcg, 2 inhalations BID
Other Names:
  • SCH 418131
  • MK-0887A
  • DULERA®
EXPERIMENTAL: MF/F MDI 50/10 mcg BID
Drug: MF/F Metered Dose Inhaler (MDI) 25/5 mcg
MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID)
Other Names:
  • SCH 418131
  • MK-0887A
  • DULERA®
Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Drug: Rescue medication: Prednisone/Prednisolone
Prednisone/Prednisolone for rescue medication, taken as directed
EXPERIMENTAL: MF/F MDI 100/10 mcg BID
Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Drug: Rescue medication: Prednisone/Prednisolone
Prednisone/Prednisolone for rescue medication, taken as directed
Drug: MF/F MDI 50/5 mcg
MF/F MDI 50/5 mcg, 2 inhalations BID
Other Names:
  • SCH 418131
  • MK-0887A
  • DULERA®
ACTIVE_COMPARATOR: BDP HFA 160 mcg BID
Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Drug: Rescue medication: Prednisone/Prednisolone
Prednisone/Prednisolone for rescue medication, taken as directed
Drug: BDP hydrofluoroalkane (HFA) 80 mcg
BDP HFA 80 mcg, 2 inhalations BID
Other Names:
  • QVAR®
  • BECONASE AQ®
ACTIVE_COMPARATOR: Montelukast 5 mg QD (4 mg QD for 5-year-olds)
Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Drug: Rescue medication: Prednisone/Prednisolone
Prednisone/Prednisolone for rescue medication, taken as directed
Drug: Montelukast tablets 5 mg (4 mg for children 5 years of age)

Montelukast chewable tablets 5 mg once daily (QD) for children 6-11 years of age

OR

Montelukast chewable tablets 4 mg QD for children 5 years of age

Other Names:
  • MK-0476
  • SINGULAIR®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs
Time Frame: Baseline (Day 1) and Day 42
Baseline (Day 1) and Day 42

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough)
Time Frame: Baseline (Day 1) and Day 42
Baseline (Day 1) and Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P05574
  • 2009-010108-27 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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