Primary:To compare the effect of UMEC/VI (62.5/25 mcg once daily) with UMEC (62.5 mcg once daily) on lung functionSecondary:To compare UMEC/VI, UMEC with salmeterol (50 mcg twice daily) on patient reported outcomes and on other COPD efficacy…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline in FEV1 at week 24.
Secondary outcome
Change in transient dyspnea index (TDI) over 24 weeks. Respiratory daily
symptoms over 24 weeks using Evaluating Respiratory Symptoms- COPD (E-RS).
Change from baseline for the St. George*s Respiratory Questionnaire (SGRQ-C).
Change from baseline in COPD assessment test (CAT). COPD exacerbations.
Clinically important deterioration (CID, composite endpoint). Rescue medication
use. Lung function parameters. Global impression disease severity. Adverse
events.
Background summary
Drug therapy of chronic obstructive airway disease (COPD) is used to improve
lung function, reduce symptoms, reduce the frequency and severity of
exacerbations, and also to improve health status and exercise tolerance.
Maintenance treatment is recommended primarily through the use of longacting
beta antagonists (LABAs) or longacting muscarinic receptor antagonists (LAMAs).
COPD treatment guidelines recommend an incremental approach to pharmacological
treatment as the disease state worsens, involving the use of combinations of
drug classes with different or complementary mechanisms.
UMEC/VI inhalation powder is a combination of the LAMA UMEC (umeclidinium
bromide) and the LABA VI (vilanterol), delivered via the ELLIPTA dry powder
inhaler. UMEC/VI at a dose of 62.5/25mcg once-daily and UMEC (62.5mcg) are
marketed in the European Union under the trade names Anoro and Incruse
respectively as a maintenance bronchodilator treatment for adults with COPD.
Salmeterol (50 mcg) is a LABA that has long been used for the maintenance
treatment of COPD.
The primary purpose of this study is to demonstrate improvements in lung
function in subjects treated with UMEC/VI compared with UMEC for 24 weeks. A
further important aspect of the study is to evaluate the effect of UMC/VI,
UMEC, and salmeterol with respect to quality of life, and lung function.
Clinically important deterioration is a novel, exploratory composite endpoint
which assesses individual deteriorations in lung function and in patient
reported outcomes defined by the accepted minimal clinically important
difference, as well as the incidence of moderate to severe exacerbations.
Clinically important deterioration will be analyzed to determine whether
UMEC/VI therapy provides greater clinical stability as compared with UMEC and
salmeterol monotherapies.
Study objective
Primary:
To compare the effect of UMEC/VI (62.5/25 mcg once daily) with UMEC (62.5 mcg
once daily) on lung function
Secondary:
To compare UMEC/VI, UMEC with salmeterol (50 mcg twice daily) on patient
reported outcomes and on other COPD efficacy measures. Safety and tolerability.
Study design
Randomized, double blind, double dummy, 3-arm study. Screening max. 6 weeks.
Run-in period (4 weeks) on current medication (excluding inhaled steroids) plus
salbutamol if needed. Subjects with a moderate or severe COPD exacerbation
during the run-in period will be deemed run-in failures. Randomization (after
discontinuation of current treatment) 1:1:1:
* UMEC/VI ( 62.5/25 mcg) once-daily in the ELLIPTA dry powder inhaler (DPI)
* UMEC (62.5mcg) once daily in the ELLIPTA DPI
* Salmeterol (50 mg) twice daily in the DISKUS DPI.
for 24 weeks. Follow-up 1 week.
Approx. 3200 subjects screened, 2400 included and 2200 completed.
Intervention
Treatment with UMEC/VI, UMEC or salmeterol.
Study burden and risks
Risk: Adverse events of UMEC/VI, UMEC or salmeterol. Worsening of COPD due to
discontinuation of current medication.
Burden:
5 visits and 9 phone calls in 35 weeks.
Pregnancy test: 3 times.
Pulmonary function tests: 4 times.
ECG: 1 time.
Chest X-ray: once.
Entire study period: 1. Daily diary use of rescue medication, adverse events 2.
Daily symptoms questionnaire.
Questionnaires: performance capacity, symptoms and quality of life.
Optional: genetics blood sample (6 ml), activity monitoring.
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
* Males and females 40 years and above.
* COPD based on ATS/ERS current guidelines.
* Current and former smokers with a cigarette smoking history of *10 pack years. See protocol page 27 for details.
* Female participants of childbearing potential who agrees to follow the contraceptive guidance page 27-28 of the protocol.
Exclusion criteria
* Asthma, alpha-1-antitrypsin deficiency or other relevant respiratory disorder, see protocol page 28 for details.
* Unstable liver disease or unstable or life threatening cardiac disease, see protocol page 28-29 for details.
* Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction, unless, in the opinion of the study physician, the benefit outweighs the risk.
* Hospitalization for COPD or pneumonia within 12 weeks prior to screening.
* Had received ICS or ICS/LABA for COPD in the 6 weeks prior to screening.
* Had >1 moderate exacerbation in the 12 months prior to screening, or 1 severe exacerbation requiring hospitalisation in the 12 months prior screening.
* Respiratory tract infection <7 days prior to screening.
* Use of the medications mentioned on page 30 of the protocol according to the defined time intervals prior to screening.
* Unable to read and/or not able to complete questionnaires on the electronic diary.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002513-22-NL |
| CCMO | NL61284.100.17 |
| Other | www.gskclinicalstudyregister.com (201749) |