Last updated: 03/15/2022 08:20:10

Unmet Need, Symptom Burden, and Health Care Utilisation of COPD Patients Receiving Respiratory Maintenance Therapy in the UK

GSK study ID
208757
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: Unmet Need, Symptom Burden, and Health Care Utilisation of COPD Patients Receiving Respiratory Maintenance Therapy in the UK
Trial description: COPD is a heterogeneous group of disorders including chronic bronchitis and emphysema that is characterized by airflow obstruction. This obstruction in airflow is both progressive and largely irreversible. In this observational study, the primary aim is to characterize the demographic and clinical characteristics of a COPD population treated in primary care. These primary care subjects could be treated with either monotherapy including Long-Acting Muscarinic Antagonist (LAMA), Long-Acting Beta Agonist (LABA), dual therapy that included Inhaled Corticosteroid (ICS)/LABA, LABA/LAMA or a multiple inhaler triple therapy (LAMA/LABA/ICS). Subjects with the history of COPD from UK via Clinical Practice Research Datalink (CPRD) with a Hospital Episode Statistics (HES) link will be part of this study. The study will collect data from January 01 2007 until December 31 2017.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of subjects who initiated a new inhaled maintenance therapy

Timeframe: Up to Day 1825

Number of subjects with demographic characteristics

Timeframe: Up to Day 1825

Number of subjects with clinical characteristics

Timeframe: Up to Day 1825

Medical Research Council (MRC) dyspnea scale measurement prior to the initiation of newly inhaled maintenance therapy

Timeframe: Up to Day 1825

COPD Global initiative for chronic Obstructive Lung Disease (GOLD) grade of airflow limitation measurement prior to the initiation of newly inhaled maintenance therapy

Timeframe: Up to Day 1825

GOLD 2017 scale prior to the initiation of newly inhaled maintenance therapy

Timeframe: Up to Day 1825

Acute Exacerbations of COPD (AECOPD) history prior to the initiation of newly inhaled maintenance therapy

Timeframe: Up to Day 1825

Number of hospitalizations 12 months prior to, and including, the index date

Timeframe: Up to Day 1825

Percentage of subjects with hospitalization 12 months prior to, and including, the index date

Timeframe: Up to Day 1825

Number of primary care consultations in the 12 months prior to, and including, the index date

Timeframe: Up to Day 1825

Percentage of subjects with primary care consultations in the 12 months prior to, and including, the index date

Timeframe: Up to Day 1825

Joint breathlessness Score 12 months prior to the initiation of the newly inhaled maintenance therapy

Timeframe: Up to Day 1825

Number of subjects who received an immediate treatment prior to initiating a new inhaled maintenance therapy

Timeframe: Up to Day 1825

Number of subjects with Joint MRC and AECOPD scores

Timeframe: Up to Day 1825

Medical Research Council (MRC) dyspnea scale measurement 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

COPD GOLD grade of airflow limitation measurement 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

GOLD 2017 scale 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

Acute Exacerbations of COPD (AECOPD) history 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

Number of hospitalization in the 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

Percentage of subjects with hospitalization 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

Number of primary care consultations in the 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

Percentage of subjects with primary care consultations 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

Number of subjects with Joint MRC and AECOPD score 12-months after the index date of therapy initiation

Timeframe: Up to Day 1825

Secondary outcomes:
Not applicable
Interventions:
  • Other: COPD GOLD grade of airflow limitation measurement
  • Other: GOLD 2017
  • Other: Acute Exacerbations of COPD
  • Other: Medical Research Council dyspnea scale measurement
    • Enrollment:
    2000
    Primary completion date:
    2020-01-05
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Leah Sansbury, David Lipson, Chanchal Bains, Glenn Anley, Kieran Rothnie, Afisi Ismaila. Disease Burden and Health-Care Utilization Among Patients with Chronic Obstructive Pulmonary Disease (COPD) in England. Int J Chron Obstruct Pulmon Dis. 2022;2022(17):415-426 DOI: 10.2147/COPD.S336158 PMID: NULL
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    June 2018 to May 2020
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    35+ years
    Accepts healthy volunteers
    None
    • For COPD cohort entry, one or more record for COPD diagnosis and age of 35 years or older at time of COPD diagnosis record between January 1, 2007 - December 31, 2016.
    • An FEV1/ Forced Vital Capacity (FVC) <0.7 at any time in the patient history.
    • Subjects with an occurrence of a code for a medical condition incompatible with COPD diagnosis any time in their history
    Inclusion and exclusion criteria
    Inclusion criteria:
    • For COPD cohort entry, one or more record for COPD diagnosis and age of 35 years or older at time of COPD diagnosis record between January 1, 2007
    • December 31, 2016.
    • An FEV1/ Forced Vital Capacity (FVC) <0.7 at any time in the patient history.
    • Record linked to the Hospital Episode Statistics (HES).
    • Prescription of a new inhaled respiratory maintenance therapy (LAMA, LABA, LAMA/LABA. LABA/ICS, LABA/LAMA/ICS) from January 1, 2014
    • December 31, 2016, of which the subject persisted on for at least 12 months in the observational period. If a subject persisted on more than one maintenance therapy for at least 12 months during the observational period, the first new inhaled maintenance therapy received by the patient and was taken for at least 12 months during this observational period, will be recorded and will define the index date.
    • No prior history of the specific index inhaled maintenance therapy (including drugs of a similar class) in 12 months prior to the index date (Short-Acting Bronchodilator [SABD] use is allowable throughout).
    • At least 12 months of history in the CPRD prior to the index date along with 12 months of follow-up date after the index date.
    Exclusion criteria:
    • Subjects with an occurrence of a code for a medical condition incompatible with COPD diagnosis any time in their history

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    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
    2020-01-05
    Actual study completion date
    2020-01-05

    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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