Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00676052
First received: May 8, 2008
Last updated: October 25, 2012
Last verified: October 2012
  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
Pulmonary Disease, Chronic Obstructive
Drug: GSK233705 12.5mcg
Drug: GSK233705 25mcg
Drug: GSK233705 50mcg
Drug: GSK233705 100mcg
Drug: GSK233705 200mcg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dose-Ranging Study for GSK233705B Delivered Once Daily in Subjects With COPD

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in Clinic Visit trough FEV1 (lung function test) on Day 29 [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-adjusted AUC for 24-hour serial FEV1 and FVC on Days 1-2 and 28-29 [ Time Frame: Days 1-2 and Days 28-29 ]
  • Change from baseline in clinic visit trough FVC on Day 29 [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Enrollment: 576
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
GSK233705 12.5mcg
Drug: GSK233705 12.5mcg
Once daily via dry powder inhaler
Other Name: GSK233705 12.5mcg
Experimental: Arm 2
GSK233705 25mcg
Drug: GSK233705 25mcg
once daily via dry powder inhaler
Other Name: GSK233705 25mcg
Experimental: Arm 3
GSK233705 50mcg
Drug: GSK233705 50mcg
Once daily via dry powder inhaler
Other Name: GSK233705 50mcg
Experimental: Arm 4
GSK233705 100mcg
Drug: GSK233705 100mcg
Once daily via dry powder inhaler
Other Name: GSK233705 100mcg
Experimental: Arm 5
GSK233705 200mcg
Drug: GSK233705 200mcg
Once daily via dry powder inhaler
Other Name: GSK233705 200mcg
Placebo Comparator: Arm 6
Placebo
Drug: Placebo
Once daily via dry powder imhaler
Other Name: Placebo

  Eligibility

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

Inclusion Criteria:

  • 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 Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676052

  Show 84 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Bateman E, Feldmann G, Kilbride S, Brooks J, Harris S, Maden C, Crater G. Efficacy and safety of the long-acting muscarinic antagonist, GSK233705, dosed once daily, in the treatment of COPD. [Clin Respir J]. 2012;Epub ahead of print.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00676052     History of Changes
Other Study ID Numbers: AC2110664
Study First Received: May 8, 2008
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
COPD
Multicenter
GSK233705B
double-blind
Chronic Obstructive Pulmonary Disease (COPD)
randomized

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014