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

NCT00676052 | Completed Phase 2 Results

• 1 other identifier: AC2110664
• Study Type: interventional
• Target: 576
• Locations: 14 countries
• Sites: 88

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; Multicenter; GSK233705B; double-blind; Chronic Obstructive Pulmonary Disease (COPD); randomized

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29

  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

  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

  Baseline (pre-dose Day 1) and Day 29

Study Arms (6)

Arm 1

EXPERIMENTAL

GSK233705 12.5mcg

Drug: GSK233705 12.5mcg

Arm 2

EXPERIMENTAL

GSK233705 25mcg

Drug: GSK233705 25mcg

Arm 3

EXPERIMENTAL

GSK233705 50mcg

Drug: GSK233705 50mcg

Arm 4

EXPERIMENTAL

GSK233705 100mcg

Drug: GSK233705 100mcg

Arm 5

EXPERIMENTAL

GSK233705 200mcg

Drug: GSK233705 200mcg

Arm 6

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

GSK233705 12.5mcg DRUG

Once daily via dry powder inhaler

Arm 1

GSK233705 25mcg DRUG

once daily via dry powder inhaler

Arm 2

GSK233705 50mcg DRUG

Once daily via dry powder inhaler

Arm 3

GSK233705 100mcg DRUG

Once daily via dry powder inhaler

Arm 4

GSK233705 200mcg DRUG

Once daily via dry powder inhaler

Arm 5

Placebo DRUG

Once daily via dry powder imhaler

Arm 6

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (88)

GSK Investigational Site

Jasper, Alabama, 35501, United States

Location

GSK Investigational Site

Glendale, Arizona, 85306, United States

Location

GSK Investigational Site

Fountain Valley, California, 92708, United States

Location

GSK Investigational Site

Fullerton, California, 92835, United States

Location

GSK Investigational Site

Los Angeles, California, 90048, United States

Location

GSK Investigational Site

Los Angeles, California, 90095, United States

Location

GSK Investigational Site

Riverside, California, 92506, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

San Diego, California, 92103-8415, United States

Location

GSK Investigational Site

Brandon, Florida, 33511, United States

Location

GSK Investigational Site

Panama City, Florida, 32405, United States

Location

GSK Investigational Site

South Miami, Florida, 33143, United States

Location

GSK Investigational Site

Coeur d'Alene, Idaho, 83814, United States

Location

GSK Investigational Site

Madisonville, Kentucky, 42431, United States

Location

GSK Investigational Site

Lafayette, Louisiana, 70503, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

Location

GSK Investigational Site

Saint Charles, Missouri, 63301, United States

Location

GSK Investigational Site

Charlotte, North Carolina, 28207, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

Location

GSK Investigational Site

Greenville, South Carolina, 29615, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Union, South Carolina, 29379, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Abingdon, Virginia, 24210, United States

Location

GSK Investigational Site

Richmond, Virginia, 23229, United States

Location

GSK Investigational Site

La Plata, Buenos Aires, CP1900, Argentina

Location

GSK Investigational Site

Mar del Plata, Buenos Aires, 7600, Argentina

Location

GSK Investigational Site

Mar del Plata, Buenos Aires, B7600FZN, Argentina

Location

GSK Investigational Site

Pergamino, Buenos Aires, 2700, Argentina

Location

GSK Investigational Site

San Miguel de Tucumán, 4000, Argentina

Location

GSK Investigational Site

Dimitrovgrad, 6400, Bulgaria

Location

GSK Investigational Site

Rousse, 7000, Bulgaria

Location

GSK Investigational Site

Sofia, 1431, Bulgaria

Location

GSK Investigational Site

Sofia, Bulgaria

Location

GSK Investigational Site

Calgary, Alberta, T2N 4N1, Canada

Location

GSK Investigational Site

Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

Location

GSK Investigational Site

Mississauga, Ontario, L5A 3V4, Canada

Location

GSK Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 1N8, Canada

Location

GSK Investigational Site

Saint Romuald, Quebec, G6W 5M6, Canada

Location

GSK Investigational Site

Sainte Jerome, Quebec, J7Z 5T3, Canada

Location

GSK Investigational Site

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

GSK Investigational Site

Valparaíso, Región de Valparaíso, 2341131, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500551, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500691, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Location

GSK Investigational Site

Santiago, 8380453, Chile

Location

GSK Investigational Site

Wiesloch, Baden-Wurttemberg, 69168, Germany

Location

GSK Investigational Site

Gelnhausen, Hesse, 63571, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30167, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01307, Germany

Location

GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

GSK Investigational Site

Lübeck, Schleswig-Holstein, 23552, Germany

Location

GSK Investigational Site

Schmölln, Thuringia, 04626, Germany

Location

GSK Investigational Site

Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, 10559, Germany

Location

GSK Investigational Site

Berlin, 10717, Germany

Location

GSK Investigational Site

Berlin, 10787, Germany

Location

GSK Investigational Site

Berlin, 14057, Germany

Location

GSK Investigational Site

Balassagyarmat, 2660, Hungary

Location

GSK Investigational Site

Budapest, 1095, Hungary

Location

GSK Investigational Site

Budapest, H-1529, Hungary

Location

GSK Investigational Site

Mátraháza, 3233, Hungary

Location

GSK Investigational Site

Almelo, 7609 PP, Netherlands

Location

GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

Location

GSK Investigational Site

Hoofddorp, 2134 TM, Netherlands

Location

GSK Investigational Site

Hoorn, 1624 NP, Netherlands

Location

GSK Investigational Site

Cavite, 4114, Philippines

Location

GSK Investigational Site

Quezon City, 1100, Philippines

Location

GSK Investigational Site

Quezon City, 1109, Philippines

Location

GSK Investigational Site

Brasov, 500112, Romania

Location

GSK Investigational Site

Bucharest, 020125, Romania

Location

GSK Investigational Site

Iași, 700115, Romania

Location

GSK Investigational Site

Cape Town, Gauteng, 7505, South Africa

Location

GSK Investigational Site

Mueckelneck, Gauteng, 0001, South Africa

Location

GSK Investigational Site

Parktown, Gauteng, 2193, South Africa

Location

GSK Investigational Site

Bellville, 7531, South Africa

Location

GSK Investigational Site

Mowbray, 7700, South Africa

Location

GSK Investigational Site

Seoul, 133--792, South Korea

Location

GSK Investigational Site

Seoul, 152-703, South Korea

Location

GSK Investigational Site

Bangkok, 10700, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

GSK Investigational Site

Songkhla, 90110, Thailand

Location

GSK Investigational Site

Brighton, Sussex East, BN2 5BE, United Kingdom

Location

GSK Investigational Site

London, SE5 9PJ, United Kingdom

Location

GSK Investigational Site

Norwich, NR4 7UY, United Kingdom

Location

Related Publications (1)

• Bateman E, Feldman G, Kilbride S, Brooks J, Mehta R, Harris S, Maden C, Crater G. Efficacy and safety of the long-acting muscarinic antagonist GSK233705 delivered once daily in patients with COPD. Clin Respir J. 2012 Oct;6(4):248-57. doi: 10.1111/j.1752-699X.2011.00278.x. Epub 2012 Feb 13.

  PMID: 22329914 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 12, 2008
• Study Start: May 16, 2008
• Primary Completion: December 22, 2008
• Study Completion: December 22, 2008
• Last Updated: October 9, 2017
• Results First Posted: September 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

RO (3); ZA (5); TH (4); BU (4); PH (3); KR (2); GB (3); US (25); DE (13); AR (5); CA (8); CL (5); HU (4); NL (4)