Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)

February 7, 2022 updated by: Organon and Co

A 1-Year Safety Study of Medium and High Doses of Mometasone Furoate/Formoterol Combination Formulation and Medium and High Doses of Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroids

The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind.

In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Phase 3

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

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months.

  • Use of medium or high daily dose of ICS (alone or in combination with long-acting beta-agonist [LABA]) for at least 12 weeks prior to Screening and have been on a stable regimen for at least 2 weeks prior to Screening.

    • Medium daily doses of ICS:

      • > 500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
      • > 250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
      • > 600 to 1000 mcg budesonide dry powder inhaler (DPI)
      • > 1000 to 2000 mcg flunisolide
      • > 250 to 500 mcg fluticasone
      • 400 mcg MF
      • > 1000 to 2000 mcg triamcinolone acetonide

    • High daily doses of ICS:

      • > 1000 mcg beclomethasone CFC
      • > 500 mcg beclomethasone HFA
      • > 1000 mcg budesonide DPI
      • > 2000 mcg flunisolide
      • > 500 mcg fluticasone
      • > 400 mcg MF
      • > 2000 mcg triamcinolone acetonide
  • If there is no inherent harm in changing the subject's current asthma therapy, the subject must discontinue prescribed ICS or ICS/LABA combination at Baseline.
  • Must show evidence of reversibility within the last 12 months or during the Screening Period. Historical reversibility defined as an increase in absolute forced expiratory volume in 1 second (FEV1) of >= 12% and >= 200 mL will qualify if performed within 12 months of Screening. If no historical reversibility, subject must demonstrate an absolute FEV1 of >= 12% and >= 200 mL within 10 to 15 minutes after four puffs of salbutamol at Visit 1 or anytime prior to Baseline.
  • At Screening and Baseline, FEV1 must be >= 50% predicted, when restricted medications are withheld for the appropriate intervals.
  • Complete blood count, blood chemistries, urinalysis, and electrocardiogram (ECG) conducted at Screening must be within normal limits or clinically acceptable to the investigator/sponsor. A chest x-ray performed at Screening or within 12 months prior must be clinically acceptable.

  • A female of childbearing potential must be using a medically acceptable, adequate form of birth control:

    • prescribed hormonal contraceptives;
    • medically prescribed intrauterine device (IUD);
    • medically prescribed transdermal contraceptive;
    • condom in combination with spermicide;
    • monogamous relationship with a male partner who has had a vasectomy.

Birth control must have started at least 3 months prior to Screening. Subject must agree to continue its use for the duration of the study. A subject of childbearing potential who is not currently sexually active must agree to use a medically acceptable method should she become sexually active during the study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A subject of childbearing potential must have a negative serum pregnancy test at Screening.

Key Exclusion Criteria:

  • A change (increase or decrease) in absolute FEV1 of > 20% at any time from the Screening Visit up to, and including, the Baseline Visit.
  • A subject who requires the use of > 12 inhalations per day of short-acting beta-agonist (SABA) MDI or > 2 nebulized treatments per day of 2.5 mg salbutamol, on any 2 consecutive days from the Screening Visit up to, and including, the Baseline Visit.
  • A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication [other than SABA]) at any time from the Screening Visit up to, and including, the Baseline Visit.
  • A subject who has ever required ventilator support for respiratory failure secondary to asthma.
  • A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history > 10 pack-years.

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MF/F 200/10 mcg BID
Drug: mometasone furoate combination MDI 200/10 mcg BID
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
Other Names:
  • SCH 418131
EXPERIMENTAL: MF/F 400/10 mcg BID
Drug: mometasone furoate combination MDI 400/10 mcg BID
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
Other Names:
  • SCH 418131
ACTIVE_COMPARATOR: F/SC 250/50 mcg BID
Drug: Fluticasone/Salmeterol 250/50 mcg BID
F/SC 250/50 twice daily for 1 year
Other Names:
  • Seretide
ACTIVE_COMPARATOR: F/SC 500/50 mcg BID
Drug: Fluticasone/Salmeterol 500/50 mcg BID
F/SC 500/50 twice daily for 1 year
Other Names:
  • Seretide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of All Randomized Subjects Reporting Adverse Events (AEs).
Time Frame: 1 year
AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.
1 year

Collaborators and Investigators

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

Sponsor

Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2006

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

September 19, 2006

First Submitted That Met QC Criteria

September 19, 2006

First Posted (ESTIMATE)

September 21, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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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