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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04360226
• Lead Sponsor: Respiratory Effectiveness Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Study Start: 2020-12-14
• Primary Completion: 2023-08-01
• Status Verified: 2024-01
• Study Completion: 2024-01-25
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exacerbations	12 months	Time to first exacerbation associated with different levels of PIF.
Prevalence of suboptimal PIF and inadequate inhaler choice.	Baseline	Determine the prevalence of suboptimal PIF and inadequate inhaler choice.

Secondary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (13)

University Hospital Sassari; 🇮🇹 Sassari, Italy

Hanyang University Guri Hospital; 🇰🇷 Hanyang, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Mater Dei Hospital; 🇲🇹 Valletta, Malta

Changi General Hospital; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore

Ljubljana University Medical Centre; 🇸🇮 Ljubljana, Slovenia

Hospital University de Torrecárdenas; 🇪🇸 Almeria, Spain

University Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

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