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Sponsors and Collaborators: |
Schering-Plough Novartis |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00604500 |
This is an open-label, multiple-dose, study of MF/F MDI 100/10 mcg BID (2 puffs of MF/F 50/5 mcg, administered twice a day approximately 12 hours apart) in subjects 12 years of age or older, with a diagnosis of asthma or COPD of at least 12 months. The primary purpose of the study is to evaluate the performance of a new metered-dose inhaler that is integrated with a dose counter under normal patient handling
Condition | Intervention | Phase |
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Asthma COPD |
Drug: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F ) |
Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open-Label, Multi-Center, Patient Handling Study of Mometasone Furoate/Formoterol Fumarate MDI With an Integrated Dose Counter in Adolescent and Adult Subjects and Adult With Asthma or COPD |
Estimated Enrollment: | 240 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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MF/F MDI 100/10 mcg BID: Experimental
MF/F MDI 100/10 mcg BID (two inhalations of 50/5 mcg inhaler BID); Familiarization Period: placebo MDI without dose counter; Screening Period: without dose counter; Treatment Period: with dose counter
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Drug: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )
MF/F MDI 100/10 mcg BID (two inhalations of a 50/5 mcg inhaler BID); Familiarization Period: placebo MDI without dose counter plus currently; prescribed asthma/COPD therapy; Screening Period: MDI without a dose counter; Treatment Period: MDI with a dose counter
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject who has experienced an upper or lower respiratory tract infection (viral or bacterial), including sinus or middle ear infections, within the previous 2 weeks prior to Screening and Baseline Visits.
Exclusion Criteria:
Responsible Party: | Schering-Plough Research Institute ( Heribert Staudinger, MD/Vice President of Allergy & Respiratory Diseases, Clinical Immunology ) |
Study ID Numbers: | P04703, 3462123 |
Study First Received: | January 21, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00604500 |
Health Authority: | United States: Food and Drug Administration |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Mometasone furoate Lung Diseases |
Hypersensitivity, Immediate Formoterol Asthma Respiratory Hypersensitivity Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |