Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. B) Assess the clinical role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden. C) Assess the variability and correlation of PIF with other lung function measurements and CAT score in stable COPD. It is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.
Interventions
OTHERNon-interventional
Non-interventional, subjects will only have routine testing (blood biomarkers, spirometry, peak inspiratory flow measurements) and be asked to complete questionnaires.
Sponsors
Boehringer Ingelheim
Respiratory Effectiveness Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Spirometry-defined COPD (i.e. post-bronchodilator FEV1/FVC\<0.7) 2. Age ≥40 years 3. Smokers or ex-smokers of at least 10 pack-years 4. Clinically stable COPD (no exacerbations in the last 4 weeks) 5. Capable of performing serial lung function tests 6. Prescribed inhaled medication for at least 6 months
Exclusion criteria
1. Occurrence of an COPD exacerbation during the previous 4 weeks 2. Have any concomitant chronic respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis, tuberculosis) 3. Are unable to understand the instructions of the study or to fill the questionnaires 4. Are unwilling to sign the informed consent 5. Are participating in a clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of suboptimal PIF and inadequate inhaler choice. | Baseline | Determine the prevalence of suboptimal PIF and inadequate inhaler choice. |
| Exacerbations | 12 months | Time to first exacerbation associated with different levels of PIF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PIF and symptom burden | Baseline, 6 and 12 months | PIF measurements will be correlated with COPD Assessment Test (CAT) Scores. CAT scores range from 0-40 depending on the severity of a persons symptoms; higher scores denote a more severe impact of COPD on a patient's life. |
| Mortality | 6 and 12 months | Annual mortality rate associated with different PIF levels. |
| Variability and correlation of PIF | Baseline, 6 and 12 months | Variability of PIF over time and the correlation between PIF and other lung function measures (including FEV1, FVC, Inspiratory capacity), CAT scores, T2 markers (nasal polyps and dermatitis) and where available blood biomarkers. |
| Exacerbation rate | 6 and 12 months | Annual rate of exacerbations associated with different PIF levels |
Countries
Italy, Malta, Singapore, Slovenia, South Korea, Spain
Outcome results
None listed