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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360226
• Other study ID #: REG-RES1801
• Status: Completed
• Start date: December 14, 2020
• Est. completion date: January 25, 2024

Study information

• Verified date: January 2024
• Source: Respiratory Effectiveness Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 25, 2024
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Italy	University Hospital Sassari	Sassari
Korea, Republic of	Hanyang University Guri Hospital	Hanyang
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan
Malta	Mater Dei Hospital	Valletta
Singapore	Changi General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Slovenia	Ljubljana University Medical Centre	Ljubljana
Spain	Hospital University de Torrecárdenas	Almeria
Spain	University Hospital Vall d'Hebron	Barcelona
Spain	Hospital Inmaculada HLA	Granada
Spain	HU Virgen de las Nieves	Granada
Spain	Hospital Universitario de La Ribera	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Respiratory Effectiveness Group	Boehringer Ingelheim

Countries where clinical trial is conducted

Italy,  Korea, Republic of,  Malta,  Singapore,  Slovenia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of suboptimal PIF and inadequate inhaler choice.	Determine the prevalence of suboptimal PIF and inadequate inhaler choice.	Baseline
Primary	Exacerbations	Time to first exacerbation associated with different levels of PIF.	12 months
Secondary	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
Secondary	Mortality	Annual mortality rate associated with different PIF levels.	6 and 12 months
Secondary	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
Secondary	Exacerbation rate	Annual rate of exacerbations associated with different PIF levels	6 and 12 months