Last updated: 02/06/2024 05:55:13

Characteristics of chronic obstructive pulmonary disease participants receiving single device dual inhaler therapy in the United Kingdom

GSK study ID
214731
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: Characteristics and treatment pathways among patients with chronic obstructive pulmonary disease receiving single device dual inhaler therapy in the UK in a real-world setting
Trial description: The primary objective of this observational cohort analysis study is to describe the characteristics of participants with chronic obstructive pulmonary disease (COPD) receiving single device dual inhaler therapy (dual therapy), specifically long-acting muscarinic antagonist (LAMA)/ long-acting beta-agonist (LABA) or inhaled corticosteroids (ICS)/LABA, in a general practice (GP) cohort from England.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Sociodemographic characteristics of participants

Timeframe: Up to 12 months prior to index date

Clinical characteristics of participants

Timeframe: Up to 24 months prior to index date

Number of participants with respiratory medication use

Timeframe: Baseline (up to 12 months prior to index date) to 12 months post-index date

All cause healthcare resource utilization

Timeframe: Baseline (up to 12 months prior to index date) to 12 months post-index date

COPD-related healthcare resource utilization

Timeframe: Baseline (up to 12 months prior to index date) to 12 months post-index date

Direct medical costs (derived using appropriate unit cost data)

Timeframe: Baseline (up to 12 months prior to index date) to 12 months post-index date

Rate of moderate to severe acute exacerbations of COPD (AECOPD)

Timeframe: Up to 12 months post-index date

Time-to-first on-treatment COPD-related AECOPD

Timeframe: Up to 12 months post-index date

Time-to-triple therapy

Timeframe: Up to 12 months post-index date

Proportion of days covered

Timeframe: Up to 18 months post-index date

Time from treatment initiation to discontinuation

Timeframe: Up to 18 months post-index date

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-15-04
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Requena G, Banks V, Czira A, Wood R, Tritton T, Wild R, Compton C, Duarte M, Ismaila AS. Characterization of patients with chronic obstructive pulmonary disease initiating single-inhaler long-acting muscarinic antagonist/long-acting ß2-agonist dual therapy in a primary care setting in England. Int J Chron Obstruct Pulmon Dis. 2022;2022(17):1781-1795 DOI: 10.2147/COPD.S365480 PMID: 35983168
Czira A, Banks V, Requena G, Wood R, Tritton T, Wild R, Compton C, Duarte M, Ismaila A.Characterisation of patients with chronic obstructive pulmonary disease initiating single-device inhaled corticosteroids/long-acting β2-agonist dual therapy in a primary care setting in England.BMJ Open Respir Res.2022;9(1):e001243 DOI: 10.1136/bmjresp-2022-001243
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Adelphi Group Limited, Adelphi Real World
Study date(s)
February 2021 to April 2021
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
  • At least one diagnostic code of COPD at age 35 years or above in the primary care setting.
  • At least one prescription of a single-device LAMA/LABA or ICS/ LABA inhaler within the indexing period with a prior COPD diagnosis. The first/ earliest within-class prescription will determine the index date for analysis.
  • At least one diagnostic code of any medical conditions incompatible with a COPD diagnosis at any time in the participant’s medical history, example; conditions that are related to lung or bronchial developmental anomalies, degenerative processes (cystic fibrosis, pulmonary fibrosis) pulmonary resection or other significant respiratory disorders other than COPD that can interfere with clinical COPD diagnosis or substantially change the natural history of the disease.
Inclusion and exclusion criteria
Inclusion criteria:
  • At least one diagnostic code of COPD at age 35 years or above in the primary care setting.
  • At least one prescription of a single-device LAMA/LABA or ICS/ LABA inhaler within the indexing period with a prior COPD diagnosis. The first/ earliest within-class prescription will determine the index date for analysis.
  • A forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) <0.7 at any time in the participant history prior to and including index date.
  • Record linked to hospital episode statistics.
  • Continuously registered with a general practitioner practice for a minimum of 12 months (365.25 days) prior to the index date.
Exclusion criteria:
  • At least one diagnostic code of any medical conditions incompatible with a COPD diagnosis at any time in the participant’s medical history, example; conditions that are related to lung or bronchial developmental anomalies, degenerative processes (cystic fibrosis, pulmonary fibrosis) pulmonary resection or other significant respiratory disorders other than COPD that can interfere with clinical COPD diagnosis or substantially change the natural history of the disease.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
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
2021-15-04
Actual study completion date
2021-15-04

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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