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

Respiratory Effectiveness Group

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04360226

REG-RES1801

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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