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Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients
This study is currenly Recruiting patients.
Sponsored by:
AstraZeneca
Purpose
This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg
one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm
should be the group to refer to when safety results of formoterol arm will be evaluated. 240
patients with moderate-to-severe COPD will be randomised (120 patients in the formoterol-arm
and 120 patients on standard COPD therapy).
Study Type: Intervention
| Condition | Intervention | Phase |
|
Chronic Obstructive Pulmonary Disease |
Drug: Formoterol (OT) | Phase 3 |
Study Design:Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official Title: An Open Phase III, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Formoterol 18 μg Daily Dose Compared With Standard COPD Treatment, in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Further Study Details:
Expected Total Enrollment:
Study Dates:December 2009 -
Eligibility
Ages Eligible for Study- Min: 40 Years Max: N/A
Gender: Both
Criteria
Inclusion Criteria:
Outpatients, men or women ≥ 40 years
A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.
Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%,
post-bronchodilator
Exclusion Criteria:
A history and/or current clinical diagnosis of asthma and atopic diseases such as
Allergic rhinitis
Patients who have experienced COPD exacerbation requiring at least one of the
following treatment, hospitalisation and/or a course of systemic steroid within 4
weeks prior to the study start.
Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart
failure, uncontrolled hypertension as defined by the investigator, or any other
relevant cardiovascular disorder as judged by the investigator
Inclusion Criteria:
post-bronchodilator
Exclusion Criteria:
Allergic rhinitis
following treatment, hospitalisation and/or a course of systemic steroid within 4
weeks prior to the study start.
failure, uncontrolled hypertension as defined by the investigator, or any other
relevant cardiovascular disorder as judged by the investigator
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT01047553
Hokkaido
Research Site - Chitose, Hokkaido
Research Site - Obihiro, Hokkaido
Research Site - Sapporo, Hokkaido
Kanagawa
Research Site - Fujisawa, Kanagawa
Research Site - Kawasaki-shi, Kanagawa
Research Site - Yokohama, Kanagawa
Tokyo
Research Site - Bunkyo, Tokyo
Research Site - Chuo, Tokyo
Research Site - Katsushika-ku, Tokyo
Research Site - Kodaira, Tokyo
Research Site - Setagaya, Tokyo
Research Site - Tosima-ku, Tokyo
More Information
Record Last Reviewed:June 2010
Last Updated:June 21, 2010
Record First Recieved:January 12, 2010
ClinicalTrials.gov Identifier:NCT01047553
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 02, 2010
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