Clinical trial NCT04360226: Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations
Official title: Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Respiratory Effectiveness Group
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2020-04-24
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of suboptimal PIF and inadequate inhaler choice.
timeFrame: Baseline
measure: Exacerbations
timeFrame: 12 months
Secondary outcomes:
measure: PIF and symptom burden
timeFrame: Baseline, 6 and 12 months
measure: Mortality
timeFrame: 6 and 12 months
measure: Variability and correlation of PIF
timeFrame: Baseline, 6 and 12 months
measure: Exacerbation rate
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: University Hospital Sassari
city: Hanyang
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Valletta
country: Malta
facility: Mater Dei Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Ljubljana
country: Slovenia
facility: Ljubljana University Medical Centre
city: Almeria
country: Spain
facility: Hospital University de Torrecárdenas
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Granada
country: Spain
facility: Hospital Inmaculada HLA
city: Granada
country: Spain
facility: HU Virgen de las Nieves
city: Valencia
country: Spain
facility: Hospital Universitario de La Ribera
Study officials:
affiliation: National Heart and Lung Institute, Imperial College London & Royal Brompton Hosp
name: Omar Usmani, MD
role: PRINCIPAL_INVESTIGATOR
References: