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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Non-interventional

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Italy
  • Sassari, Italy
    • University Hospital Sassari
• Korea, Republic of
  • Hanyang, Korea, Republic of
    • Hanyang University Guri Hospital
  • Seoul, Korea, Republic of
    • Seoul st. mary's hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
• Malta
  • Valletta, Malta
    • Mater Dei Hospital
• Singapore
  • Singapore, Singapore
    • Singapore General Hospital
  • Singapore, Singapore
    • Changi General Hospital
• Slovenia
  • Ljubljana, Slovenia
    • Ljubljana University Medical Centre
• Spain
  • Almeria, Spain
    • Hospital University de Torrecárdenas
  • Barcelona, Spain
    • University Hospital Vall d'Hebron
  • Granada, Spain
    • Hospital Inmaculada HLA
  • Granada, Spain
    • HU Virgen de las Nieves
  • Valencia, Spain
    • Hospital Universitario de la Ribera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

COPD patients, who are clinically stable (4 exacerbations in previous 4 weeks) and have been taking inhaled medications for at least 6 months, but have no other chronic respiratory conditions, other than asthma or bronchiectasis.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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

Collaborators and Investigators

• Sponsor: Respiratory Effectiveness Group
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Omar Usmani, MD, National Heart and Lung Institute, Imperial College London & Royal Brompton Hosp

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: REG-RES1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No