Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00628862

Purpose

The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Formoterol Turbuhaler 4.5mg Drug: Formoterol Turbuhaler 9 mg Drug: Turbuhaler placebo	Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Arformoterol Tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-National, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To show that formoterol 4.5 μg and 9 μg twice daily are superior to placebo in Japanese and European COPD patients treated for 12 weeks by evaluation of FEV1 60 minutes post-dose as the primary outcome variable. [ Time Frame: evaluated 60 minutes post-dose for 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the onset of action of formoterol 4.5 μg and 9 μg using placebo as a control, by evaluation of FEV1 as the primary objective [ Time Frame: Evaluated 5 minutes post-dose at Visit 3 ] [ Designated as safety issue: No ]
Compare the effect of formoterol 4.5 μg twice daily to that of formoterol 9 μg twice daily by evaluation of the same primary and secondary variables as for the primary objective [ Time Frame: evaluated at each visit for 12 weeks ] [ Designated as safety issue: No ]
Evaluate the safety of formoterol 4.5 μg and 9 μg twice daily for 12 weeks in terms of: - Adverse events, laboratory variables, 12-lead ECG, blood pressure and pulse rate [ Time Frame: evaluated at each visit for 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	613
Study Start Date:	December 2007
Study Completion Date:	April 2009

Arms	Assigned Interventions
1: No Intervention Placebo Turbuhaler	Drug: Turbuhaler placebo placebo inhaled twice daily
2: Experimental Formoterol Turbuhaler 4.5mg	Drug: Formoterol Turbuhaler 4.5mg 4.5 mg inhaled twice daily
3: Experimental Formoterol Turbuhaler 9 mg	Drug: Formoterol Turbuhaler 9 mg 9 mg inhaled twice daily

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
Current or previous smoker with a smoking history of 10 or more pack years
Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value

Exclusion Criteria:

History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628862

Show 48 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Lars-Goran Carlsson, MD	AstraZeneca R&D Lund, Sweden
Principal Investigator:	Miron A Bogdan, MD	Clinica Medic Or, Calea

More Information

No publications provided

Responsible Party:	AstraZeneca R&D Lund, Sweden ( Lars-Göran Carlsson,Medical Science Director, MD )
Study ID Numbers:	D5122C00001, EudraCT no 2007-003999-19
Study First Received:	January 24, 2008
Last Updated:	May 4, 2009
ClinicalTrials.gov Identifier:	NCT00628862 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency; Bulgaria: Bulgarian Drug Agency; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health

Keywords provided by AstraZeneca:

Chronic Obstructive Pulmonary Disease
COPD

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Adrenergic Agonists
Lung Diseases, Obstructive

Respiratory Tract Diseases
Lung Diseases
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions

Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009