Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations
This is an international, multi-centre, non-interventional study that aims to-
- Determine the prevalence of suboptimal peak inspiratory flow (PIF) and inadequate inhalers and the baseline characteristics of these groups
- Assess the role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden.
- Assess the role of blood biomarkers and Th2 markers in predicting COPD exacerbations and the variability and correlation of PIF with other biomarkers and lung function measurements in stable COPD.
Rationale
Dry Powder Inhalers (DPIs) require that patients have sufficient peak inspiratory flows (PIF) to disaggregate the powder into particles that can adequately be inhaled into the lower respiratory tract1.
The prevalence of suboptimal PIF in studies has varied greatly between studies1-5 and there is mixed evidence from previous studies as to whether PIF correlates with other measures of lung function2-4.
Following hospitalisation for a COPD exacerbation suboptimal PIF has been associated with a higher risk of readmission for COPD and worse symptom burdens4.
There is a need to further assess PIF particularly in stable COPD patients and in a larger, multi-centre study to investigate the predictive value of PIF in terms symptom burden and future exacerbation risk.
Study design
This is a 12 month prospective observational study, with a baseline visit and 2 follow-up visits at 6 and 12 months.
Study Population
We will be recruiting 400 patients across approximately 20 centres.
To be eligible for inclusion in the study patients should have:
- Spirometry-defined COPD (i.e. post-bronchodilator FEV1/FVC<0.7)
- Be aged ≥40 years
- Smokers or ex-smokers of at least 10 pack-years
- Have clinically stable COPD (no exacerbations in the 4 wks prior to baseline visit)
- Be capable of performing serial lung function tests
- Be prescribed inhaled medication for at least 6 months
Patients will be excluded if they:
- 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 complete the questionnaires
- Are unwilling to sign the informed consent
- Are participating in a clinical trial
Planned study sites
| Principal Investigator | Centre | Country |
| Katrina Tonga | Sydney | Australia |
| Belinda Cochrane | Sydney | Australia |
| Soo Wei Foo | Sydney | Australia |
| Therese Lapperre | Antwerp UH | Belgium |
| Sebastian Karlsson | Bispebjerg Hosp | Denmark |
| Richard Costello | RCSI/ Beaumont Hosp | Ireland |
| Pietro Pirina | UH Sassari | Italy |
| Caroline Gouder | Mater Dei Hosp | Malta |
| Pawel Sliwinski | Inst. of TB & Lung Diseases | Poland |
| Sean Loh | Changi GH | Singapore |
| Pei Yee Tiew | Singapore GH | Singapore |
| Matevz Harlander | Ljubljana UMC | Slovenia |
| Chin Kook Rhee | St Mary's Hospital | S. Korea |
| Marc Miravitlles | Vall d’Hebron UH | Spain |
| Bernardino Alcazar | H Alta Resolución | Spain |
| Miguel Roman-Rodrigeuz | IdISPa | Spain |
| Pedro Romero | Hospital HLA Inmaculada | Spain |
Study Steering Committee
Omar Usmani (Chief Investigator)
Marc Miravitlles
Sinthia Bosnic-Anticevich
Status
This study has now completed recruitment and is therefore closed. If you would like further information please contact Valeria Perugini (valeria@regresearchnetwork.org).
Study registrations
ENCePP number: EUPAS34689
Clinicaltrials.gov number: NCT04360226
Funding
Boehringer Ingelheim
References
- Ghosh et al. International Journal of COPD 2019:14 585–595.
- Janssens et al. Eur Respir J. 2008;31(1):78–83.
- Mahler et al. J Aerosol Med Pulm Drug Deliv. 2013;26(3):174–179.
- Loh et al. Ann Am Thorac Soc. 2017;14(8):1305–1311.
- Sharma et al. Chronic Obstr Pulm Dis. 2017;4(3):217–224.