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

NCT ID: NCT00676052

Last Updated: 2017-10-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-16

Study Completion Date

2008-12-22

Brief Summary

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

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

GSK233705 12.5mcg

Group Type EXPERIMENTAL

GSK233705 12.5mcg

Intervention Type DRUG

Once daily via dry powder inhaler

Arm 2

GSK233705 25mcg

Group Type EXPERIMENTAL

GSK233705 25mcg

Intervention Type DRUG

once daily via dry powder inhaler

Arm 3

GSK233705 50mcg

Group Type EXPERIMENTAL

GSK233705 50mcg

Intervention Type DRUG

Once daily via dry powder inhaler

Arm 4

GSK233705 100mcg

Group Type EXPERIMENTAL

GSK233705 100mcg

Intervention Type DRUG

Once daily via dry powder inhaler

Arm 5

GSK233705 200mcg

Group Type EXPERIMENTAL

GSK233705 200mcg

Intervention Type DRUG

Once daily via dry powder inhaler

Arm 6

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily via dry powder imhaler

Interventions

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GSK233705 12.5mcg

Once daily via dry powder inhaler

Intervention Type DRUG

GSK233705 25mcg

once daily via dry powder inhaler

Intervention Type DRUG

GSK233705 50mcg

Once daily via dry powder inhaler

Intervention Type DRUG

GSK233705 100mcg

Once daily via dry powder inhaler

Intervention Type DRUG

GSK233705 200mcg

Once daily via dry powder inhaler

Intervention Type DRUG

Placebo

Once daily via dry powder imhaler

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Jasper, Alabama, United States

Site Status

GSK Investigational Site

Glendale, Arizona, United States

Site Status

GSK Investigational Site

Fountain Valley, California, United States

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GSK Investigational Site

Fullerton, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Los Angeles, California, United States

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GSK Investigational Site

Riverside, California, United States

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GSK Investigational Site

Roseville, California, United States

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GSK Investigational Site

San Diego, California, United States

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GSK Investigational Site

Brandon, Florida, United States

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GSK Investigational Site

Panama City, Florida, United States

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GSK Investigational Site

South Miami, Florida, United States

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GSK Investigational Site

Coeur d'Alene, Idaho, United States

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GSK Investigational Site

Madisonville, Kentucky, United States

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GSK Investigational Site

Lafayette, Louisiana, United States

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GSK Investigational Site

Sunset, Louisiana, United States

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GSK Investigational Site

Saint Charles, Missouri, United States

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GSK Investigational Site

Charlotte, North Carolina, United States

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GSK Investigational Site

Charleston, South Carolina, United States

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GSK Investigational Site

Greenville, South Carolina, United States

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GSK Investigational Site

Spartanburg, South Carolina, United States

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GSK Investigational Site

Union, South Carolina, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Abingdon, Virginia, United States

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GSK Investigational Site

Richmond, Virginia, United States

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GSK Investigational Site

La Plata, Buenos Aires, Argentina

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GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

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GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

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GSK Investigational Site

Pergamino, Buenos Aires, Argentina

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GSK Investigational Site

San Miguel de Tucumán, , Argentina

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GSK Investigational Site

Dimitrovgrad, , Bulgaria

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GSK Investigational Site

Rousse, , Bulgaria

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GSK Investigational Site

Sofia, , Bulgaria

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GSK Investigational Site

Sofia, , Bulgaria

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GSK Investigational Site

Calgary, Alberta, Canada

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GSK Investigational Site

Bay Roberts, Newfoundland and Labrador, Canada

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GSK Investigational Site

Mississauga, Ontario, Canada

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GSK Investigational Site

Ottawa, Ontario, Canada

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GSK Investigational Site

Toronto, Ontario, Canada

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GSK Investigational Site

Saint Romuald, Quebec, Canada

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GSK Investigational Site

Sainte Jerome, Quebec, Canada

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GSK Investigational Site

Sainte-Foy, Quebec, Canada

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GSK Investigational Site

Valparaíso, Región de Valparaíso, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Santiago, , Chile

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GSK Investigational Site

Wiesloch, Baden-Wurttemberg, Germany

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GSK Investigational Site

Gelnhausen, Hesse, Germany

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GSK Investigational Site

Hanover, Lower Saxony, Germany

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GSK Investigational Site

Hanover, Lower Saxony, Germany

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GSK Investigational Site

Dresden, Saxony, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

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GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

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GSK Investigational Site

Schmölln, Thuringia, Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Balassagyarmat, , Hungary

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GSK Investigational Site

Budapest, , Hungary

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GSK Investigational Site

Budapest, , Hungary

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GSK Investigational Site

Mátraháza, , Hungary

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GSK Investigational Site

Almelo, , Netherlands

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GSK Investigational Site

Eindhoven, , Netherlands

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GSK Investigational Site

Hoofddorp, , Netherlands

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GSK Investigational Site

Hoorn, , Netherlands

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GSK Investigational Site

Cavite, , Philippines

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GSK Investigational Site

Quezon City, , Philippines

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GSK Investigational Site

Quezon City, , Philippines

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GSK Investigational Site

Brasov, , Romania

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GSK Investigational Site

Bucharest, , Romania

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GSK Investigational Site

Iași, , Romania

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GSK Investigational Site

Cape Town, Gauteng, South Africa

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GSK Investigational Site

Mueckelneck, Gauteng, South Africa

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GSK Investigational Site

Parktown, Gauteng, South Africa

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GSK Investigational Site

Bellville, , South Africa

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GSK Investigational Site

Mowbray, , South Africa

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Bangkok, , Thailand

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GSK Investigational Site

Chiang Mai, , Thailand

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GSK Investigational Site

Khon Kaen, , Thailand

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GSK Investigational Site

Songkhla, , Thailand

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GSK Investigational Site

Brighton, Sussex East, United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Norwich, , United Kingdom

Site Status

Countries

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

References

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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.

Reference Type DERIVED
PMID: 22329914 (View on PubMed)

Study Documents

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Document Type: Annotated Case Report Form

View Document

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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AC2110664

Identifier Type: -

Identifier Source: org_study_id