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| Sponsored by: |
Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00379288 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: mometasone furoate combination MDI 200/10 mcg BID Drug: mometasone furoate combination MDI 400/10 mcg BID Drug: Fluticasone/Salmeterol 250/50 mcg BID Drug: Fluticasone/Salmeterol 500/50 mcg BID |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 360 |
| Study Start Date: | June 2006 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| MF/F 200/10 mcg BID: Experimental |
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
|
| MF/F 400/10 mcg BID: Experimental |
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
|
| F/SC 250/50 mcg BID: Active Comparator |
Drug: Fluticasone/Salmeterol 250/50 mcg BID
FS/c 250/50 twice daily for 1 year
|
| F/SC 500/50 mcg BID: Active Comparator |
Drug: Fluticasone/Salmeterol 500/50 mcg BID
FS/C 500/50 twice daily for 1 year
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
High daily doses of ICS:
A female of childbearing potential must be using a medically acceptable, adequate form of birth control:
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.
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology ) |
| Study ID Numbers: | P04139 |
| Study First Received: | September 19, 2006 |
| Last Updated: | February 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00379288 History of Changes |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Peru: National Institute of Health; Mexico: Ministry of Health; Chile: Instituto de Salud Publica de Chile; Ecuador: Public Health Ministry; Guatemala:Ministry of Public Health and Social Welfare |
|
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Adrenergic Agents Adrenergic beta-Agonists Mometasone furoate Albuterol Anti-Asthmatic Agents Asthma |
Anti-Allergic Agents Adrenergic Agonists Vitamin C Fluticasone Formoterol Peripheral Nervous System Agents Bronchodilator Agents Ascorbic Acid |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Salmeterol Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Mometasone furoate Physiological Effects of Drugs Albuterol Anti-Asthmatic Agents |
Reproductive Control Agents Anti-Allergic Agents Pharmacologic Actions Adrenergic Agonists Tocolytic Agents Autonomic Agents Therapeutic Uses Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |