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

NCT04360226 | Completed

• 1 other identifier: REG-RES1801
• Study Type: observational
• Target: 400
• Locations: 6 countries
• Sites: 13

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• PIF and symptom burden

  Baseline, 6 and 12 months

• Mortality

  6 and 12 months

• Variability and correlation of PIF

  Baseline, 6 and 12 months

• Exacerbation rate

  6 and 12 months

Interventions

Non-interventional OTHER

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Respiratory Effectiveness Group: lead
• Boehringer Ingelheim: collaborator

Study Sites (13)

University Hospital Sassari

Sassari, Italy

Location

Mater Dei Hospital

Valletta, Malta

Location

Changi General Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Ljubljana University Medical Centre

Ljubljana, Slovenia

Location

Hanyang University Guri Hospital

Hanyang, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Hospital University de Torrecárdenas

Almería, Spain

Location

University Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Inmaculada HLA

Granada, Spain

Location

HU Virgen de las Nieves

Granada, Spain

Location

Hospital Universitario de La Ribera

Valencia, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Omar Usmani, MD

  National Heart and Lung Institute, Imperial College London & Royal Brompton Hosp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 24, 2020
• Study Start: December 14, 2020
• Primary Completion: August 1, 2023
• Study Completion: January 25, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3); ES (5); MA (1); SL (1); IT (1); SG (2)