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Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)

NCT00383435 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1055

Last updated 2024-05-20

Study results available
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Summary

This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated

subjects who will not participate in the safety extension will be discontinued

and will have their Final Visit at Week 26. Subjects who continue into the

26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC\[0-12hr\]) and change from Baseline to Week 13 in AM predose FEV1.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Mometasone furoate/formoterol (MF/F) combination

MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks

DRUG

Mometasone furoate/formoterol (MF/F) combination

MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks

DRUG

Mometasone furoate MDI (MF MDI)

MF 400 mcg via metered dose inhaler twice daily for 52 weeks

DRUG

Formoterol MDI

Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks

DRUG

Placebo

Placebo MDI twice a day for 26 weeks

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00383435 on ClinicalTrials.gov