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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-14

Study Completion Date

2024-01-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Non-interventional

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No