Last updated: 11/07/2018 15:21:05
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Multicentre dose ranging study for once daily GSK233705 in COPD
Trial description: The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in trough forced expiratory volume in 1 second (FEV1) at Day 29
Timeframe: Baseline (pre-dose Day 1) and Day 29
Secondary outcomes:
Change from Baseline in weighted mean for 0 to 24 hours serial FEV1 on Day 1 to 2 and 28 to 29
Timeframe: Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Change from Baseline in weighted mean for 0 to 24 hours forced vital capacity (FVC) on Day 1 to 2 and 28 to 29
Timeframe: Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Change from Baseline in clinic visit trough FVC on Day 29
Timeframe: Baseline (pre-dose Day 1) and Day 29
Interventions:
Enrollment:
576
Primary completion date:
2008-22-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical 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;6(4):248-57.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
darotropium bromide
Collaborators
Not applicable
Study date(s)
May 2008 to December 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- A signed and dated written informed consent prior to study participation.
- Male or female adults.
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Women who are pregnant or lactating.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Status
Study Complete
Location
GSK Investigational Site
Brighton, Sussex East, United Kingdom, BN2 5BE
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23229
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Abingdon, Virginia, United States, 24210
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85306
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Madisonville, Kentucky, United States, 42431
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103-8415
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Status
Study Complete
Location
GSK Investigational Site
Cape Town, Gauteng, South Africa, 7505
Status
Study Complete
Location
GSK Investigational Site
Wiesloch, Baden-Wuerttemberg, Germany, 69168
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4N1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sainte Jerome, Québec, Canada, J7Z 5T3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Saint Romuald, Québec, Canada, G6W 5M6
Status
Study Complete
Location
GSK Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
South Miami, Florida, United States, 33143
Status
Terminated/Withdrawn
Location
GSK Investigational Site
La Plata, Buenos Aires, Argentina, CP1900
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Status
Study Complete
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
Union, South Carolina, United States, 29379
Status
Study Complete
Location
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, ValparaÃso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
Pergamino, Buenos Aires, Argentina, 2700
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
Status
Study Complete
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Mueckelneck, Gauteng, South Africa, 0001
Status
Study Complete
Location
GSK Investigational Site
Panama City, Florida, United States, 32405
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90095
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30167
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-22-12
Actual study completion date
2008-22-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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