Last updated: 03/13/2023 16:10:17
Comparative Effectiveness of Umeclidinium/Vilanterol versus ICS/ LABA therapy among participants with Chronic Obstructive Pulmonary Disease in United Kingdom (UK) real world
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Comparative Effectiveness of Umeclidinium/Vilanterol versus ICS/LABA as inhaled maintenance therapy among patients with Chronic Obstructive Pulmonary Disease in a UK real-world primary care setting
Trial description: This study will assess the superiority of the long-acting muscarinic antagonist (LAMA)/Long-acting beta-agonist (LABA) Umeclidinium/Vilanterol (UMEC/VI) versus Inhaled corticosteroids (ICS)/LABA [Fluticasone propionate (FP)/salmeterol xinafoate (SX), Beclomethasone Dipropionate (BDP)/Formoterol Fumarate (FF), Budesonide (BUD)/FF), fluticasone propionate (FP)/fluticasone furoate (FF)] collectively and of UMEC/VI versus BDP/FF, particularly, on medication adherence among non-exacerbating chronic obstructive pulmonary disease (COPD) participants newly initiating maintenance therapy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants adherent (proportion of days covered [PDC] greater than or equal to [>= ]80 percent [%]) to UMEC/VI or ICS/LABA
Timeframe: Up to 12 months
Secondary outcomes:
Number of participants adherent (PDC >=80%) to UMEC/VI or ICS/LABA
Timeframe: Up to 24 months
Number of participants adherent (PDC >=80%) to UMEC/VI or BDP/FF
Timeframe: Up to 24 months
Time to triple therapy between UMEC/VI or ICS/LABA
Timeframe: Up to 24 months
Time to triple therapy UMEC/VI or BDP/FF
Timeframe: Up to 24 months
Time to first on treatment moderate-to-severe Acute exacerbations of COPD (AECOPD) between UMEC/VI or ICS/LABA
Timeframe: Up to 24 months
Time to first on treatment moderate-to-severe AECOPD between UMEC/VI or BDP/FF
Timeframe: Up to 24 months
All-cause and COPD-related health care resource utilization (HCRU) and direct medical cost between UMEC/VI or ICS/LABA
Timeframe: Up to 24 months
All-cause and COPD-related HCRU and direct medical cost between UMEC/VI or BDP/FF
Timeframe: Up to 24 months
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-15-03
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
NA
Study date(s)
December 2021 to March 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
35+ years
Accepts healthy volunteers
No
- At least one diagnostic code in the primary care setting of COPD at age 35 years or above at any time in the participant history prior to the index date.
- At least one prescription of a UMEC/VI or ICS/LABA (FP/SX, BDP/FF, BUD/FF or FP/FF) within the indexing period with a prior COPD diagnosis.
- At least one diagnostic code of any medical conditions incompatible with a COPD diagnosis at any time in the participant’s medical history, that is (i.e.) 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.
- Use of any COPD maintenance therapy (i.e. any long-acting bronchodilator: LAMA or LABA) at any time prior to the index date.
Inclusion and exclusion criteria
Inclusion criteria:
- At least one diagnostic code in the primary care setting of COPD at age 35 years or above at any time in the participant history prior to the index date.
- At least one prescription of a UMEC/VI or ICS/LABA (FP/SX, BDP/FF, BUD/FF or FP/FF) within the indexing period with a prior COPD diagnosis.
- A forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than (<) 0.7 at any time in the participant history prior to and including index date.
- Record linked to Hospital Episode Statistics (HES).
- Continuously registered with a General practitioner (GP) 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, that is (i.e.) 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.
- Use of any COPD maintenance therapy (i.e. any long-acting bronchodilator: LAMA or LABA) at any time prior to the index date.
- A prescription for both UMEC/VI and ICS/LABA therapy on the index date.
- For participants indexed on UMEC/VI, concomitant use of an ICS-containing medication at index date.
- For participants indexed on ICS/LABA (or BDP/FF), concomitant use of a LAMA-containing medication at index date.
- One or more AECOPDs in the 12 months prior to and including the index date.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
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
2022-15-03
Actual study completion date
2022-15-03
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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