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OpenTrials
Completed

NCT Number: NCT04360226

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Sassari, Sassari, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Non-Interventional

Other

Non-interventional, subjects will only have routine testing (blood biomarkers, spirometry, peak inspiratory flow measurements) and be asked to complete questionnaires.

Primary outcomes

  1. Prevalence of suboptimal PIF and inadequate inhaler choice.

    Time frame: Baseline

    Determine the prevalence of suboptimal PIF and inadequate inhaler choice.

  2. Exacerbations

    Time frame: 12 months

    Time to first exacerbation associated with different levels of PIF.

Secondary outcomes

  1. PIF and symptom burden

    Time frame: 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

    Time frame: 6 and 12 months

    Annual mortality rate associated with different PIF levels.

  3. Variability and correlation of PIF

    Time frame: 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

    Time frame: 6 and 12 months

    Annual rate of exacerbations associated with different PIF levels

Sponsors and collaborators

Lead sponsor

Respiratory Effectiveness Group

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Apr 24, 2020
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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