Last updated: 11/07/2018 08:32:54
Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects from primary careACCESS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects from primary care
Trial description: This is a prospective, observational, non-drug interventional, non-randomized study to compare the rate of moderate–severe COPD exacerbations in patients of all Chronic Obstructive Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study population of 3330 subjects will be recruited by general practitioners (GPs) and assessed over a 27 month time frame.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Frequency of COPD Exacerbation
Timeframe: From 15 months pre-baseline to 24 months post-baseline.
Presence and severity of cardiovascular disease.
Timeframe: From 3 months pre-baseline to 24 months post-baseline.
Secondary outcomes:
Presence and severity of other comorbidities
Timeframe: Up to 24 months post baseline.
Spirometry
Timeframe: Up to 24 months post baseline.
Health status
Timeframe: Up to 24 months post baseline.
Dyspnoea
Timeframe: Up to 24 months post baseline.
Number of Deaths
Timeframe: up to 24 months post baseline.
Healthcare Utilisation
Timeframe: Up to 24 months post baseline.
Blood Chemistry
Timeframe: Up to 24 months post baseline.
Electrocardiogram
Timeframe: Up to 24 months post baseline.
Bone fractures
Timeframe: Within 12 months prior to baseline and up to 24 months post baseline
Interventions:
Enrollment:
3500
Primary completion date:
Not applicable
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Paul W Jones, Hana Mullerova, Alvar Agusti, Marc Decramer, Lukasz Adamek, Alice Raillard, Chang-Qing Zhu, Jadwiga A Wedzicha. Cardiovascular disease does not predict exacerbation rate or mortality in COPD. Am J Respir Crit Care Med. 2018;197(3):400-403
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
November 2011 to June 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Male or female patients aged ≥ 40 years
- An established clinical history of COPD for a minimum of 12 months, of any severity.
- In the opinion of the investigator, there is a current primary diagnosis of asthma (patients with a primary diagnosis of COPD but who also have asthma may be included)
- A diagnosis of fibrosis or asbestosis
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female patients aged ≥ 40 years
- An established clinical history of COPD for a minimum of 12 months, of any severity.
- FEV1/FVC post-bronchodilator ratio < 0.70 (within the last 12 months, or confirmed at the screening visit [or 4 weeks after the screening visit if patient’s COPD is not stable]).
- Current or ex-smokers with a smoking history of at least 10 pack-years
- A signed and dated written informed consent is obtained prior to participation
Exclusion criteria:
- In the opinion of the investigator, there is a current primary diagnosis of asthma (patients with a primary diagnosis of COPD but who also have asthma may be included)
- A diagnosis of fibrosis or asbestosis
- Diagnosis of cancer – current or within the last 5 years (patients in remission for ≥ 5 years may be included). Patients diagnosed with cancer during the study will be withdrawn
- Diagnosis of clinically significant bronchiectasis
- Subjects who are concurrently participating in any clinical study or who have received any investigational drugs within 4 weeks of baseline, or who will start any during the study period.
- Unable to or unwilling to conform with the study requirements including completion of the health status questionnaires
- Females who are pregnant or lactating.
Trial location(s)
Location
GSK Investigational Site
Cornellá de Llobregat-Barcelona, Spain, 08940
Status
Study Complete
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Study documents
Scientific result summary
Available language(s): English
Protocol
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
Not applicable
Actual study completion date
2015-12-06
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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