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

Sponsor
Respiratory Effectiveness Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT04360226
Collaborator
Boehringer Ingelheim (Industry)
400
Enrollment
13
Locations
23.6
Anticipated Duration (Months)
30.8
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-interventional

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations
Actual Study Start Date :
Dec 14, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Prevalence of suboptimal PIF and inadequate inhaler choice. [Baseline]

    Determine the prevalence of suboptimal PIF and inadequate inhaler choice.

  2. Exacerbations [12 months]

    Time to first exacerbation associated with different levels of PIF.

Secondary Outcome Measures

  1. 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.

  2. Mortality [6 and 12 months]

    Annual mortality rate associated with different PIF levels.

  3. 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.

  4. Exacerbation rate [6 and 12 months]

    Annual rate of exacerbations associated with different PIF levels

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Sassari Sassari Italy
2 Hanyang University Guri Hospital Hanyang Korea, Republic of
3 Seoul St. Mary's Hospital Seoul Korea, Republic of
4 Ulsan University Hospital Ulsan Korea, Republic of
5 Mater Dei Hospital Valletta Malta
6 Changi General Hospital Singapore Singapore
7 Singapore General Hospital Singapore Singapore
8 Ljubljana University Medical Centre Ljubljana Slovenia
9 Hospital University de Torrecárdenas Almeria Spain
10 University Hospital Vall d'Hebron Barcelona Spain
11 Hospital Inmaculada HLA Granada Spain
12 HU Virgen de las Nieves Granada Spain
13 Hospital Universitario de La Ribera Valencia Spain

Sponsors and Collaborators

  • Respiratory Effectiveness Group
  • Boehringer Ingelheim

Investigators

  • Principal Investigator: Omar Usmani, MD, National Heart and Lung Institute, Imperial College London & Royal Brompton Hosp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Respiratory Effectiveness Group
ClinicalTrials.gov Identifier:
NCT04360226
Other Study ID Numbers:
  • REG-RES1801
First Posted:
Apr 24, 2020
Last Update Posted:
Dec 3, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Dec 3, 2021