Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations

Study Overview
=================
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.

Official Title
-----------------
Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spirometry-defined COPD (i.e. post-bronchodilator FEV1/FVC<0.7) Age ≥40 years Smokers or ex-smokers of at least 10 pack-years Clinically stable COPD (no exacerbations in the last 4 weeks) Capable of performing serial lung function tests Prescribed inhaled medication for at least 6 months Exclusion Criteria: Occurrence of an COPD exacerbation during the previous 4 weeks Have any concomitant chronic respiratory condition other than asthma or bronchiectasis (e.g. cystic fibrosis, lung fibrosis, tuberculosis) Are unable to understand the instructions of the study or to fill the questionnaires Are unwilling to sign the informed consent Are participating in a clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-interventional|Non-interventional, subjects will only have routine testing (blood biomarkers, spirometry, peak inspiratory flow measurements) and be asked to complete questionnaires.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of suboptimal PIF and inadequate inhaler choice. | Determine the prevalence of suboptimal PIF and inadequate inhaler choice. | Baseline | 
| Exacerbations | Time to first exacerbation associated with different levels of PIF. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PIF and symptom burden | 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. | Baseline, 6 and 12 months | 
| Mortality | Annual mortality rate associated with different PIF levels. | 6 and 12 months | 
| Variability and correlation of PIF | 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. | Baseline, 6 and 12 months | 
| Exacerbation rate | Annual rate of exacerbations associated with different PIF levels | 6 and 12 months |