Last updated: 11/07/2018 07:41:35
An exercise endurance study to evaluate the effects of treatment of Chronic Obstructive Pulmonary Disease (COPD) patients with a dual bronchodilator: GSK573719/GW642444.Study BCOPD
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An exercise endurance study to evaluate the effects of treatment of Chronic Obstructive Pulmonary Disease (COPD) patients with a dual bronchodilator: GSK573719/GW642444. Study B
Trial description: This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI).
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in exercise endurance time post-dose at Week 12 of each treatment period
Timeframe: Week 12 of each treatment period (up to Study Week 30)
Change from Baseline in trough forced expiratory volume in one second (FEV1) at Week 12 of each treatment period
Timeframe: Week 12 of each treatment period (up to Study Week 30)
Secondary outcomes:
Change from Baseline in inspiratory capacity (trough and 3-hours post-dose) at Week 12 of each treatment period
Timeframe: Week 12 of each treatment period (up to Study Week 30)
Change from Baseline in functional residual capacity (trough and 3-hours post-dose) at Week 12 of each treatment period
Timeframe: Week 12 of each treatment period (up to Study Week 30)
Change from Baseline in residual volume (trough and 3-hours post-dose) at Week 12 of each treatment period
Timeframe: Week 12 of each treatment period (up to Study Week 30)
Change from Baseline in 3-hours post-dose FEV1 at Week 12 of each treatment period
Timeframe: Week 12 of each treatment period (up to Study Week 30)
Interventions:
Drug: GSK573719/GW642444 125/25
Drug: GSK573719/GW642444 62.5/25
Drug: GSK573719 125
Drug: GSK573719 62.5
Drug: GW642444 25
Device: placebo
Enrollment:
307
Observational study model:
Not applicable
Primary completion date:
2012-16-07
Time perspective:
Not applicable
Clinical publications:
Maltais F, Singh S, Donald AC, Crater G, Church A, Goh A, Riley JH .Effects of a combination of umeclidinium/vilanterol on exercise endurance in chronic obstructive pulmonary disease: Two randomised clinical trials.Ther Adv Respir Dis.2014;8:169
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
March 2011 to July 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Male
Age
40+ years
Accepts healthy volunteers
No
- Type of subject: Outpatient.
- Informed Consent: A signed and dated written informed consent prior to study participation.
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Asthma: A current diagnosis of asthma.
Inclusion and exclusion criteria
Inclusion criteria:
- Type of subject: Outpatient.
- Informed Consent: A signed and dated written informed consent prior to study participation.
- Age: 40 years of age or older at Visit 1.
- Gender: Male or female subjects.
- Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]
- Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years
- Severity of Disease: A post-albuterol/salbutamol FEV1/FVC ratio of 0.70 and a post-albuterol/salbutamol FEV1 of >35% and <70% of predicted normal
- Dyspnea: A score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1
- Resting Lung Volumes: A resting FRC of ≥120% of predicted normal FRC at Visit 1.
Exclusion criteria:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Asthma: A current diagnosis of asthma.
- Other Respiratory Disorders: Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease. Allergic rhinitis is not exclusionary.
- Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for < 5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. Any physical or mental abnormality which would affect the patient carrying out exercise tests including peripheral vascular disease should be excluded at the investigators discretion.
- Chest X-Ray: A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Visit 1 if a chest X-ray or CT scan is not available within 6 months prior to Visit 1. For subjects in Germany, if a chest X-ray (or CT scan) is not available in the 6 months prior to Visit 1 the subject will not be eligible for the study.
- Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic.
- Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
- Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
- 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1, including the presence of a paced rhythm on a 12-lead electrocardiogram (ECG) which causes the underlying rhythm and ECG to be obscured. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility.
- Screening Labs: Significantly abnormal finding from clinical chemistry and hematology tests at Visit 1.
- Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
- Medications prior to Screening, including depot,oral corticosteroids, combinations of LABA/ICS, LABA, PDE4 inhibitors.
- Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., <12 hours per day) is not exclusionary.
- Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy
- Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
- Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
- Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study
Trial location(s)
Location
GSK Investigational Site
Hartford, Connecticut, United States, 06105
Status
Study Complete
Location
GSK Investigational Site
St. Charles, Missouri, United States, 63301
Status
Study Complete
Location
GSK Investigational Site
George, Eastern Cape, South Africa, 6529
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30046
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Austin, Texas, United States, 78758
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Austell, Georgia, United States, 30106
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90505
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23225
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406-7108
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80528
Status
Study Complete
Location
GSK Investigational Site
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Status
Study Complete
Location
GSK Investigational Site
Doncaster, United Kingdom, DN2 5LT
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Leicester, Leicestershire, United Kingdom, LE3 9QP
Status
Study Complete
Location
GSK Investigational Site
The Woodlands, Texas, United States, 77380
Status
Study Complete
Location
GSK Investigational Site
Easley, South Carolina, United States, 29640
Status
Study Complete
Location
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
Status
Study Complete
Location
GSK Investigational Site
Livonia, Michigan, United States, 48152
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wolverhampton, United Kingdom, WV10 00B
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 70868
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
Completed
Actual primary completion date
2012-16-07
Actual study completion date
2012-16-07
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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