Last updated: 07/31/2020 02:00:07
Disease progression and economic evaluation of clinically important deterioration (CID): conceptual development, applications and validation
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: Disease progression and economic evaluation of clinically important deterioration (CID): conceptual development, applications and validation
Trial description: Umeclidinium/vilanterol (UMEC/VI) is a combination available for COPD treatment. COPD is a progressive respiratory disease characterized by chronic inflammation of the lungs and airways. This study is designed to examine the relationship between CID status and subsequent long-term clinical and economic outcomes. The CID-related variables along with clinical and economic outcomes will be evaluated. This study is a post-hoc analysis of Towards a Revolution in COPD Health (TORCH) trial. TORCH was a 3-year, randomized, placebo-controlled trial in subjects with moderate to severe COPD. Subjects from the TORCH trial with data available for determining CID status at 24 weeks will be included in this study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with presence or absence of CID
Timeframe: Week 24
Number of subjects achieving CID criteria
Timeframe: Week 24
Change from Baseline in trough FEV1
Timeframe: Baseline and up to Week 158
Change in trough FEV1 from 24-week visit
Timeframe: Week 24 and up to Week 158
Change from Baseline in total SGRQ score
Timeframe: Baseline and up to Week 158
Change in total SGRQ score from 24-week visit
Timeframe: Week 24 and up to Week 158
Number of moderate exacerbations after 24-week visit
Timeframe: Up to Week 158
Number of severe exacerbations after 24-week visit
Timeframe: Up to Week 158
Time to first moderate exacerbation after 24-week visit
Timeframe: Up to Week 158
Time to first severe exacerbation after 24-week visit
Timeframe: Up to Week 158
Time to death after 24-week visit
Timeframe: Up to Week 158
Number of subjects with all cause mortality
Timeframe: Up to Week 158
Change in utility score derived from SGRQ score from 24-week visit
Timeframe: Up to Week 158
Change in utility score derived from EuroQOL five dimensions questionnaire (EQ5D) from 24-week visit
Timeframe: Up to Week 158
Number of hospital stays after 24-week visit
Timeframe: Up to Week 158
Number of general ward days after 24-week visit
Timeframe: Up to Week 158
Number of intensive care unit (ICU) days after 24-week visit
Timeframe: Up to Week 158
Number of emergency room (ER) visits after 24-week visit
Timeframe: Up to Week 158
Number of office visits after 24-week visit
Timeframe: Up to Week 158
Number of home visits after 24-week visit
Timeframe: Up to Week 158
Number of outpatient visits after 24-week visit
Timeframe: Up to Week 158
Total medical costs after 24-week visit
Timeframe: Up to Week 158
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2019-25-01
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Paly V, Naya I, Gunsoy N, Driessen M, Risebrough N, Briggs A, Ismaila A.Long-term cost and utility consequences of short-term clinically important deterioration (CID) in patients with chronic obstructive pulmonary disease: results from the TORCH study .Int J Chron Obstruct Pulmon Dis.2019;14:939—951
DOI: 10.2147/COPD.S188898
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
ICON
Study date(s)
September 2017 to January 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40 - 80 Years
Accepts healthy volunteers
Not applicable
- Age: 40 to 80 years of age.
- Subjects who were current or former smokers with at least a 10-pack-year history.
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Age: 40 to 80 years of age.
- Subjects who were current or former smokers with at least a 10-pack-year history.
- Subjects who had received a diagnosis of COPD and FEV1 <=60% of the predicted value, <=10% in reversibility in predicted FEV1, and a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) of <=70%.
- Subject must have at least one visit in TORCH trial after starting treatment for which lung function testing is available and for which the SGRQ was administered.
Exclusion criteria:
- Diagnosis of other respiratory disorders (including asthma).
- Requirement for long term oxygen therapy.
- Any subject who withdrew from the in TORCH study within the first 24 weeks will be excluded.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Protocol
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
Other
Actual primary completion date
2019-25-01
Actual study completion date
2019-25-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website