Last updated: 07/31/2020 01:00:10

Meta-Analysis Plan for an analysis to compare the addition of Umeclidinium Inhalation Powder 62.5mcg to ICS/LABA with Placebo plus ICS/LABA in subjects with Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
202067
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Meta-Analysis Plan for an analysis to compare the addition of Umeclidinium Inhalation Powder 62.5mcg to ICS/LABA with Placebo plus ICS/LABA in subjects with Chronic Obstructive Pulmonary Disease (COPD)
Trial description: This study is a meta-analysis of data from four randomised controlled trials – AC4116135, AC4116136, 200109 and 200110. The purpose of this meta-analysis is to compare the addition of umeclidinium bromide (UMEC) 62.5 micrograms (mcg) to inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) with Placebo plus ICS/LABA in subjects with Chronic Obstructive Pulmonary Disease (COPD). Two studies (AC4116135 and AC4116136) utilised Fluticasone propionate 250 mcg/Salmeterol 50 mcg whereas the other two studies (200109 and 200110) utilised Fluticasone furoate 100 mcg/Vilanterol 25 mcg as the ICS/LABA combination. Data from all four studies data will be combined and analysed in this meta-analysis; in addition, data from 200109 and 200110 will be analysed separately.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from Baseline in trough forced expiratory volume in one second (FEV1) on Day 85

Timeframe: Baseline and Day 84

Secondary outcomes:

Change from Baseline in weighted mean 0-6 hour FEV1 obtained at Day 84

Timeframe: Baseline and Day 84

Change from Baseline in number of puffs of rescue medication (salbutamol) taken per day

Timeframe: Baseline and Week 1 to Week 12

Change from Baseline in percentage of rescue-free days

Timeframe: Baseline and Week 1 to Week 12

Change from Baseline in St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) total score

Timeframe: Baseline, Days 28 and 84

Change from Baseline in subjects with >=4 unit decrease in SGRQ total score

Timeframe: Baseline, Days 28 and 84

Number of COPD exacerbations

Timeframe: 12 weeks

Time to first composite endpoint of on-treatment clinically important deterioration

Timeframe: 12 weeks

Interventions:
  • Drug: Salbutamol
  • Drug: Fluticasone furoate 100 mcg/Vilanterol 25 mcg
  • Drug: Fluticasone propionate 250 mcg/Salmeterol 50 mcg
  • Drug: Umeclidinium bromide 125 mcg
  • Drug: Ipratropium bromide
  • Drug: Placebo
  • Drug: Albuterol
  • Drug: Umeclidinium bromide 62.5 mcg
    • Enrollment:
    1
    Primary completion date:
    2015-17-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Siler TM, Kerwin E, Tombs L, Fahy WA, Naya I. Triple therapy of umeclidinium + inhaled corticosteroids/long-acting beta2 agonists for patients with COPD: pooled results of randomized placebo-controlled trials. Pulmonary Ther. 2016;2(1):43-58
    Naya I, Tombs L, Lipson D, Compton C.Preventing clinically important deterioration of COPD with addition of umeclidinium to inhaled corticosteroid/long-acting β2-agonist therapy: an integrated post hoc analysis.Adv Ther.2018;35(10):1626–1638 DOI: 10.1007/s12325-018-0771-4 PMID: PMC6182634
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, umeclidinium bromide, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    October 2014 to May 2015
    Type
    Observational
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    Not applicable
    • Inclusion Criteria:
    • Subjects in the four contributing studies (AC4116135, AC4116136, 200109 and 200110) met the following
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Subjects in the four contributing studies (AC4116135, AC4116136, 200109 and 200110) met the following 1. Age >=40 years 2. Breathless; diagnosed with COPD 3. Modified Medical Research Council (mMRC) >=2 4. Post-salbutamol FEV1 <=70% predicted 5. FEV1/forced vital capacity (FVC) ratio <=0.70

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2015-17-05
    Actual study completion date
    2015-17-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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