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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 |
Study Completion Date: | November 2008 |
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: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00604500 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-Inflammatory Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Mometasone furoate Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Formoterol Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Formoterol Adrenergic beta-Agonists |
Immune System Diseases Mometasone furoate Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity Pulmonary Disease, Chronic Obstructive |