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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

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital University de Torrecárdenas
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AlmeríaSpainUnknown status
University Hospital Vall d'Hebron
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BarcelonaSpainUnknown status
HU Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Inmaculada HLA
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GranadaSpainUnknown status
Hospital Universitario de la Ribera
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ValenciaSpainUnknown status
University Hospital Sassari
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SassariItalyUnknown status
Hanyang University Guri Hospital
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HanyangSouth KoreaUnknown status
Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Mater Dei Hospital
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VallettaMaltaUnknown status
Singapore General Hospital
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SingaporeSingaporeUnknown status
Changi General Hospital
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SingaporeSingaporeUnknown status
Ljubljana University Medical Centre
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LjubljanaSloveniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.