Last updated: 11/07/2018 10:09:21
Cross-Over Study in subjects with COPD, evaluating Lung Function Response after Treatment with once daily Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomized, Double-Blind, 3-Way, Cross-Over Study to Evaluate Lung Function Response after Treatment with Umeclidinium 62.5mcg, Vilanterol 25mcg, and Umeclidinium/Vilanterol 62.5/25mcg Once-Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of this study is to evaluate the lung function response to UMEC/VI, UMEC, and VI in individual patients using a cross-over design. This is a multicenter, randomized, double-blind, 3-way crossover study. Eligible subjects will be randomized to a sequence of UMEC 62.5mcg, VI 25mcg, and UMEC/VI 62.5/25mcg. All subjects will receive each treatment once-daily for 14 days, and each treatment will be separated by a 10-14 day washout period. There will be a 5-7 day run-in period prior to randomization.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Change from Baseline (BL) in weighted mean (WM) 0-6 hour forced expiratory volume in one second (FEV1) obtained post-dose at Day 14 of each treatment period (TP) by response type
Timeframe: Baseline and Day 14 of each treatment period (up to study day 83)
Secondary outcomes:
Number of participants (par.) who were responsive to UMEC/VI, UMEC, or VI according to FEV1 at Day 1 of each treatment period (TP)
Timeframe: Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)
Number of participants with a larger change from Baseline in 0-6 hour weighted mean FEV1 at Day 14 of each treatment period with UMEC/VI compared with UMEC and VI alone
Timeframe: Baseline and Day 14 of each treatment period (up to study day 83)
Change from Baseline in trough FEV1 on Day 15 of each treatment period
Timeframe: Baseline and Day 15 of each treatment period (up to study day 84)
Interventions:
Device: Umeclidinium/Vilanterol 62.5/25 mcg
Device: Umeclidinium 62.5 mcg
Device: Vilanterol 25 mcg
Enrollment:
182
Observational study model:
Not applicable
Primary completion date:
2013-06-03
Time perspective:
Not applicable
Clinical publications:
Donohue JF, Singh D, Munzu C, Kilbride S, Church A.Magnitude of umeclidinium/vilanterol lung function effect depends on monotherapy responses: results from two randomised controlled trials.Respir Med.2016;112:65-74.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
October 2012 to March 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Type of Patient: 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 Patient: Outpatient
- Informed Consent: A signed and dated written informed consent prior to study participation
- Age: Subjects 40 years of age or older at Visit 1
- Gender: Male or female subjects.
- COPD diagnosis: As defined by the American Thoracic Society/European Respiratory Society (ATS/ERS)
- Severity of disease: A pre- and post-salbutamol FEV1/FVC ratio of <0.70 and a pre- and post-salbutamol FEV1 of ≤ 70% of predicted normal values at Visit 1
- Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years at Visit 1
- Female subject of non child-bearing potential OR a female subject of child bearing potential, with a negative pregnancy test at screening, and agreeing to consistently and correctly use one of the acceptable contraceptive methods
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 alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions.
- 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 hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for < 5 years prior to Visit 1
- 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 of 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 Visit 1.
- 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1
- Screening Labs: Significantly abnormal finding from clinical chemistry or hematology tests at Visit 1 as determined by the study investigator.
- Medication Prior to Spirometry: Unable to withhold salbutamol for the 4 hour period required prior to spirometry testing at each study visit and at each spirometry test performed at home.
- Medications Prior to Screening: Use of the prohibited medications according to defined time intervals prior to Visit 1
- 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., salbutamol, ipratropium bromide) 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.
- Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete a questionnaire
Trial location(s)
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23552
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2013-06-03
Actual study completion date
2013-06-03
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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