Clinical trial NCT04166812: Change in Airway Peripheral Tone in COPD
Official title: Role of Small Airway Dysfunction for Disease Progression in Early COPD - an Observational Two-year Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
COPD, Early-Onset
Keywords: small airway disease
peripheral airway tone
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator)
name: Chiesi GmbH, Hamburg, Germany (Funding)
First posted: 2019-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * patients at risk for COPD with no current diagnosis according to GOLD recommendations
* patients with early COPD with diagnosis according to current GOLD recommendations

Brief summary: Small airways disease is a pathological feature in mild to moderate COPD, which might be causally involved in disease progression. However, there are only limited studies available that prospectively identified patients at risk for small airway disease. Our intention is to investigate the early phase of the disease. In addition, we thereby want to build up a well-defined study population of patients in an early phase of the disease with a rapid decrease in lung function as measured by oscillometry and multiple breath washout (MBW)-testing. In addition, it is our goal to identify patients in an early stage of disease and patients at risk of fast progression and/or rapid decline in lung function.


Eligibility criteria: patients at risk for COPD

inclusion criteria:

* smoking history (at least 10 pack years)
* absence of airway obstruction (FEV1/FVC ≥ 70% after salbutamol 400µg)
* high symptom score (CAT ≥ 10) or long acting bronchodilator therapy
* age \> 35 years

exclusion criteria:

* respiratory infection within 4 weeks prior to inclusion
* other symptomatic pulmonary disease, except bronchial asthma

patients with early COPD

inclusion criteria:

* smoking history (at least 10 pack years)
* mild COPD (FEV1/FVC \< 70% and FEV1 ≥ 70% after salbutamol 400µg)
* age \> 35 years

exclusion criteria:

* respiratory infection within 4 weeks prior to inclusion
* other pulmonary disease, except bronchial asthma

Primary outcomes:
measure: oscillometry (change in R5-20)
timeFrame: 24 months
measure: multiple breath washout testing (change in LCI)
timeFrame: 24 months
measure: multiple breath washout testing (change in Scond)
timeFrame: 24 months
measure: multiple breath washout testing (change in Sacin)
timeFrame: 24 months
Secondary outcomes:
measure: spirometry (change in FEV1)
timeFrame: 24 months
measure: body plethysmography (change in RV/TLC)
timeFrame: 24 months
measure: body plethysmography (change in sRaw)
timeFrame: 24 months
measure: health Status (change in SGRQ-c)
timeFrame: 24 months
measure: health Status (change in CAT)
timeFrame: 24 months
Other outcomes:
Locations:
city: Großhansdorf
country: Germany
facility: Pulmonary Research Institute at LungClinic Großhansdorf
city: Heidelberg
country: Germany
facility: Thoraxklinik at Heidelberg University
Study officials:
affiliation: Pulmonary Research Institute at LungClinic Großhansdorf
name: Henrik Watz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoraxklinik at Heidelberg University
name: Frederik Trinkmann, MD
role: PRINCIPAL_INVESTIGATOR
References: