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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Multicentre Dose Ranging Study for Once Daily GSK233705 in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676052
• Other study ID #: AC2110664
• Status: Completed
• Phase: Phase 2
• First received: May 8, 2008
• Last updated: September 8, 2017
• Start date: May 16, 2008
• Est. completion date: December 22, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 576
• Est. completion date: December 22, 2008
• Est. primary completion date: December 22, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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 a-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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GSK233705 12.5mcg
Once daily via dry powder inhaler
• GSK233705 25mcg
once daily via dry powder inhaler
• GSK233705 50mcg
Once daily via dry powder inhaler
• GSK233705 100mcg
Once daily via dry powder inhaler
• GSK233705 200mcg
Once daily via dry powder inhaler
• Placebo
Once daily via dry powder imhaler

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	La Plata	Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Pergamino	Buenos Aires
Argentina	GSK Investigational Site	Tucuman
Bulgaria	GSK Investigational Site	Dimitrovgrad
Bulgaria	GSK Investigational Site	Ruse
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Saint Romuald	Quebec
Canada	GSK Investigational Site	Sainte Jerome	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago
Chile	GSK Investigational Site	Valparaiso	Valparaíso
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Gelnhausen	Hessen
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Schmoelln	Thueringen
Germany	GSK Investigational Site	Wiesloch	Baden-Wuerttemberg
Hungary	GSK Investigational Site	Balassagyarmat
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Mátraháza
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Netherlands	GSK Investigational Site	Almelo
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Hoofddorp
Netherlands	GSK Investigational Site	Hoorn
Philippines	GSK Investigational Site	Cavite
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Iasi
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Cape Town	Gauteng
South Africa	GSK Investigational Site	Mowbray
South Africa	GSK Investigational Site	Mueckelneck	Gauteng
South Africa	GSK Investigational Site	Parktown	Gauteng
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiangmai
Thailand	GSK Investigational Site	Khon Kaen
Thailand	GSK Investigational Site	Songkla
United Kingdom	GSK Investigational Site	Brighton	Sussex East
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Norwich
United States	GSK Investigational Site	Abingdon	Virginia
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Coeur d'Alene	Idaho
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Fullerton	California
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madisonville	Kentucky
United States	GSK Investigational Site	Panama City	Florida
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Riverside	California
United States	GSK Investigational Site	Roseville	California
United States	GSK Investigational Site	Saint Charles	Missouri
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	South Miami	Florida
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Sunset	Louisiana
United States	GSK Investigational Site	Union	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Chile,  Germany,  Hungary,  Korea, Republic of,  Netherlands,  Philippines,  Romania,  South Africa,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29	The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.	Baseline (pre-dose Day 1) and Day 29
Secondary	Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29	Weighted means serial FEV1 was derived by calculating the area under curve (AUC), and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.	Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Secondary	Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29	Weighted means serial FVC was derived by calculating the AUC, and then dividing by the time interval over which the AUC was calculated. Baseline was defined at pre-dose Day 1. The weighted mean change from Baseline is the weighted mean minus Baseline. The AUC was calculated using the trapezoidal rule. For all post-dose observations, actual times that the spirometry measurements were conducted was used for the calculation. Pre-dose observations were counted as 0 hr observations - that is they had their time set to the time of dosing. The pre-dose value used for the calculation of the AUC was the mean of the two pre-dose observations (-30 and 0 min for Day 1 or 28). If one of these observations was missing, the remaining single pre-dose observation was used.	Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Secondary	Change From Baseline in Clinic Visit Trough FVC on Day 29	The trough FVC is defined as the mean of the FVC values obtained 23 and 24 hours after dosing on Day 28. The Baseline FVC is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.	Baseline (pre-dose Day 1) and Day 29

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