Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
This study is currently recruiting participants.
Verified by GlaxoSmithKline, November 2008
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00676052
  Purpose

The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: GSK233705B
Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: Dose-Ranging Study for GSK233705B Delivered Once Daily in Subjects With COPD

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in Clinic Visit trough FEV1 (lung function test) on Day 29

Secondary Outcome Measures:
  • Time-adjusted AUC for 24-hour serial FEV1 and FVC on Days 1-2 and 28-29 Change from baseline in Clinic Visit trough FVC on Day 29
  • Change from baseline in clinic visit trough FVC on Day 29

Estimated Enrollment: 600
Study Start Date: May 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects eligible for enrollment in the study must meet all of the following criteria:

  1. A signed and dated written informed consent prior to study participation.
  2. Male or female adults.

A female is eligible to enter and participate in this study if she is of:

  1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal; or,
  2. 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) 3.40 to 80 years of age at Visit 1 4.An established clinical history of COPD 5.Current or previous cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years 1.

    6.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 Criteria:

    Subjects meeting any of the following criteria must not be enrolled in the study:

    1. Women who are pregnant or lactating.
    2. A current diagnosis of asthma.
    3. 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.
    4. Any previous lung resection surgery (e.g., lung volume reduction surgery or lobectomy)
    5. 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.
    6. Use of oral corticosteroids or antibiotics for COPD within 6 weeks prior to Visit 1.
    7. Hospitalization for COPD or pneumonia within 3 months prior to Visit 1.
    8. Use of antibiotics for a lower respiratory tract infection within 30 days prior to Visit 1.
    9. Clinically significant and uncontrolled cardiovascular, neurological, psychiatric, renal, gastro-intestinal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities.
    10. An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in active medical problem.
    11. Positive for Hepatitis B or Hepatitis C at Visit 1.
    12. A current malignancy or previous history of cancer in remission for <5 years prior to Visit 1
    13. A history of allergy or hypersensitivity to ipratropium, tiotropium, or atropine and any of their derivatives, lactose/milk protein or magnesium stearate.
    14. 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.
    15. 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).
    16. 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)
    17. Use of inhaled corticosteroids at a dose greater than 1000 mcg/day of fluticasone propionate or equivalent within 30 days prior to Visit 1.
    18. 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.
    19. Clinically significant sleep apnea that requires continuous positive airway pressure (CPAP)
    20. Use of regular nebulized therapy
    21. Use of nocturnal positive pressure or non-invasive positive pressure ventilation (NIPPV)
    22. Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1.
    23. 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
    24. 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.
    25. Use of GSK233705B in previous studies.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676052

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

  Show 109 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: AC2110664
Study First Received: May 8, 2008
Last Updated: November 6, 2008
ClinicalTrials.gov Identifier: NCT00676052  
Health Authority: United States: Food and Drug Administration;   Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:
GSK233705B
Multicenter
randomized
double-blind
COPD

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 14, 2009