Status:
COMPLETED
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.
Eligibility Criteria
Inclusion
- A signed and dated written informed consent prior to study participation.
- Male or female adults.
- A female is eligible to enter and participate in this study if she is of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal; or child-bearing potential, has a negative pregnancy test at Visit 1/Visit 1A, and agrees to one of the protocol-specified acceptable contraceptive methods used consistently and correctly (i.e. according to the approved product label and the instructions of the physician for the duration of the study - Screening through follow-up contact)
- 40 to 80 years of age at Visit 1
- An established clinical history of COPD
- Current or previous cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years 1.
- A post-albuterol/salbutamol FEV1/FVC ratio of ≤0.70 and a post-albuterol/salbutamol FEV1 of ≥35 and ≤70% of predicted normal values
Exclusion
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Women who are pregnant or lactating.
- A current diagnosis of asthma.
- Known respiratory disorders other than COPD including but not limited to α-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease.
- Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy)
- Clinically significant Chest X-ray or computed tomography (CT) scan abnormalities within 6 months prior to Visit 1 that are not believed to be due to COPD.
- Use of oral corticosteroids or antibiotics for COPD within 6 weeks prior to Visit 1.
- Hospitalization for COPD or pneumonia within 3 months prior to Visit 1.
- Use of antibiotics for a lower respiratory tract infection within 30 days prior to Visit 1.
- Clinically significant and uncontrolled cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities.
- An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in active medical problem.
- Positive for Hepatitis B or Hepatitis C at Visit 1.
- A current malignancy or previous history of cancer in remission for \<5 years prior to Visit 1
- A history of allergy or hypersensitivity to ipratropium, tiotropium, or atropine and any of their derivatives, lactose/milk protein or magnesium stearate.
- Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholingeric.
- Medically unable to withhold albuterol/salbutamol for 6 hours prior to spirometry testing at each study visit or to withhold ipratropium (if applicable) for the 6-hour period prior to the first 3 study visits (ipratropium cannot be used after Visit 3).
- Additional Medications: Unable to stop using certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
- Use of inhaled corticosteroids at a dose greater than 1000 mcg/day of fluticasone propionate or equivalent within 30 days prior to Visit 1.
- Use of long-term oxygen therapy (LTOT) or supplemental oxygen required for greater than 12 hours a day. Oxygen use as needed is not exclusionary.
- Clinically significant sleep apnea that requires continuous positive airway pressure (CPAP)
- Use of regular nebulized therapy
- Use of nocturnal positive pressure or non-invasive positive pressure ventilation (NIPPV)
- Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1.
- An investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the above who is involved in this study
- History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse in the two years prior to Visit 1 (including drug and alcohol), or other conditions, which will limit the validity of informed consent to participate in the study.
- Use of GSK233705B in previous studies.
Key Trial Info
Start Date :
May 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2008
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT00676052
Start Date
May 16 2008
End Date
December 22 2008
Last Update
October 9 2017
Active Locations (88)
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1
GSK Investigational Site
Jasper, Alabama, United States, 35501
2
GSK Investigational Site
Glendale, Arizona, United States, 85306
3
GSK Investigational Site
Fountain Valley, California, United States, 92708
4
GSK Investigational Site
Fullerton, California, United States, 92835