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

Finalized

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:

Observational study model:

Cohort

Primary completion date:

2015-17-05

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

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

Trial location(s)

No location data available.

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

Finalized

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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Access to clinical trial data by researchers

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