NCT00379288

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Jun 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

August 12, 2010

Completed
Last Updated

May 20, 2024

Status Verified

February 1, 2022

Enrollment Period

1.4 years

First QC Date

September 19, 2006

Results QC Date

July 15, 2010

Last Update Submit

May 8, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • The Number of All Randomized Subjects Reporting Adverse Events (AEs).

    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

Study Arms (4)

MF/F 200/10 mcg BID

EXPERIMENTAL
Drug: mometasone furoate combination MDI 200/10 mcg BID

MF/F 400/10 mcg BID

EXPERIMENTAL
Drug: mometasone furoate combination MDI 400/10 mcg BID

F/SC 250/50 mcg BID

ACTIVE COMPARATOR
Drug: Fluticasone/Salmeterol 250/50 mcg BID

F/SC 500/50 mcg BID

ACTIVE COMPARATOR
Drug: Fluticasone/Salmeterol 500/50 mcg BID

Interventions

mometasone furoate combination MDI 200/10 mcg BIDDRUG

MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year

Also known as: SCH 418131
MF/F 200/10 mcg BID
mometasone furoate combination MDI 400/10 mcg BIDDRUG

MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year

Also known as: SCH 418131
MF/F 400/10 mcg BID
Fluticasone/Salmeterol 250/50 mcg BIDDRUG

F/SC 250/50 twice daily for 1 year

Also known as: Seretide
F/SC 250/50 mcg BID
Fluticasone/Salmeterol 500/50 mcg BIDDRUG

F/SC 500/50 twice daily for 1 year

Also known as: Seretide
F/SC 500/50 mcg BID

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +14 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Maspero JF, Nolte H, Cherrez-Ojeda I; P04139 Study Group. Long-term safety of mometasone furoate/formoterol combination for treatment of patients with persistent asthma. J Asthma. 2010 Dec;47(10):1106-15. doi: 10.3109/02770903.2010.514634. Epub 2010 Nov 1.

    PMID: 20874458RESULT

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PMID: 36472162DERIVED

  • Maspero J, Cherrez I, Doherty DE, Tashkin DP, Kuna P, Kuo WL, Gates D, Nolte H, Chylack LT Jr. Appraisal of lens opacity with mometasone furoate/formoterol fumarate combination in patients with COPD or asthma. Respir Med. 2014 Sep;108(9):1355-62. doi: 10.1016/j.rmed.2014.04.015. Epub 2014 May 2.

    PMID: 25044280DERIVED

MeSH Terms

Conditions

Asthma

Interventions

BID protein, humanFluticasoneSalmeterol XinafoateFluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2006

First Posted

September 21, 2006

Study Start

June 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 20, 2024

Results First Posted

August 12, 2010

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share