An exercise endurance study to evaluate the effects of treatment of COPD patients with a dual bronchodilator: GSK573719/GW642444

GlaxoSmithKline0 sites341 target enrollmentMarch 29, 2011

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline
Enrollment: 341
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 29, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•1\. Type of subject: Outpatient.
•2\. Informed Consent: A signed and dated written informed consent prior to study participation.
•3\. Age: 40 years of age or older at Visit 1\.
•4\. Gender: Male or female subjects.
•A female is eligible to enter and participate in the study if she is of:
•Non\-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post\-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post\-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, \> 45 years, in the absence of hormone replacement therapy. However in questionable cases, post\-menopause status may be confirmed by analysis of a blood sample with FSH \> 40MIU/ml and estradiol \<40pg/ml (\<140 pmol/L) as confirmatory.
•Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow\-up contact):
•Abstinence
•Oral Contraceptive, either combined or progestogen alone
•Injectable progestogen

Exclusion Criteria

•1\. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
•2\. Asthma: A current diagnosis of asthma.
•3\. Other Respiratory Disorders: Known respiratory disorders other than COPD including but not limited to alpha\-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease. Allergic rhinitis is not exclusionary.
•4\. Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for \< 5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. Any physical or mental abnormality which would affect the patient carrying out exercise tests including peripheral vascular disease should be excluded at the investigators discretion.
•5\. Chest X\-Ray: A chest X\-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X\-ray must be taken at Visit 1 if a chest X\-ray or CT scan is not available within 6 months prior to Visit 1\. For subjects in Germany, if a chest X\-ray (or CT scan) is not available in the 6 months prior to Visit 1 the subject will not be eligible for the study.
•6\. Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2\-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow\-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic.
•7\. Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1\.
•8\. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1\).
•9\. 12\-Lead ECG: An abnormal and significant ECG finding from the 12\-lead ECG conducted at Visit 1, including the presence of a paced rhythm on a 12\-lead electrocardiogram (ECG) which causes the underlying rhythm and ECG to be obscured. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that precluded subject eligibility are listed in Appendix 3\. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 3\.
•10\. Screening Labs: Significantly abnormal finding from clinical chemistry and hematology tests at Visit 1\.