NCT04360226Completed
Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations
Source: ClinicalTrials.gov · Last updated 10 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 400 (actual)
- First submitted
- 19 Apr 2020
- Start date
- Dec 2020
- Primary completion date
- Aug 2023
- Lead sponsor
- Respiratory Effectiveness Group
- Diseases
- COPD
- NCT number
- NCT04360226
What you commit to
- Study type: Observational
- Participants enrolled: 400
- From Dec 2020 to the primary completion date, Aug 2023
- 13 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital University de Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Unknown status |
| University Hospital Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| HU Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Inmaculada HLA Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario de la Ribera Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| University Hospital Sassari Coordinator of this site? Confirm its status | Sassari | Italy | Unknown status |
| Hanyang University Guri Hospital Coordinator of this site? Confirm its status | Hanyang | South Korea | Unknown status |
| Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Mater Dei Hospital Coordinator of this site? Confirm its status | Valletta | Malta | Unknown status |
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Changi General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Ljubljana University Medical Centre Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.