Oscillometry in the COPD Exacerbator Phenotype With Triple Inhaled Therapy Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge
About this trial
The objective of this observational study is to determine the effectiveness of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) and frequent worsening of their respiratory symptoms by using a device called an oscillometer. This instrument is capable of measuring bronchial obstruction and air trapping in the lungs through vibrations during normal breathing. The main question it seeks to answer is:
Could oscillometry be useful in assessing the effectiveness of inhaled corticosteroids in patients with COPD exacerbations, in terms of bronchial obstruction and air trapping in the lungs? Patients who choose to participate will undergo oscillometry testing and complete standard COPD questionnaires during three follow-up visits spread over three months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years.
Diagnosis of COPD.
Severe-moderate COPD measured by FEV1 and stable.
Patient receiving dual bronchodilation therapy (LABA/LAMA) for at least the last 4 months prior to study inclusion and meeting clinical criteria to begin triple inhaled therapy.
Disqualifiers
COPD in the last 4 weeks, with use of antibiotics or systemic corticosteroids.
Chronic lung disease other than COPD.
Severe heart failure, with frequent decompensation (in cases of mild decompensation or onset without severe heart disease, do not include the patient within 3 months of decompensation).
Active neoplastic processes.
Trial population
Patients with exacerbating COPD from the pulmonology clinics of 6 hospitals in Catalonia, Spain.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
63 Participants
are grouped into 3 trial groupsGroup A: Central bronchial obstruction
Group B: Peripheral bronchial obstruction
Group C: Pulmonary hyperinflation
Trial outcomes
Primary outcomes
1
Oscillometric results
R19, R5, R5-19, X19, X5, ∆Xrs (cmH2O/(L/s)
Time frame
on each of the 3 visits (baseline, week 4, week 12)Secondary outcomes
1
Spirometric results
FVC, FEV1
Time frame
initial and at visit 3 (baseline and week 12)2
COPD Assessment Test (CAT)
score range 0-40, a higher score indicates a more severe impact of the disease on the patient's life.
Time frame
on each of the 3 visits (baseline, week 4, week 12)3
Test of Adherence of Inhalers (TAI)
Items 1 to 5 assess "erratic" non-compliance (score between 5 and 25); items 6 to 10 assess "deliberate" non-compliance (score between 5 and 25); items 11 and 12 assess "unconscious" non-compliance (score between 2 and 4).
Time frame
on each of the 3 visits (baseline, week 4, week 12)4
Spirometric results (forced expiratory volume in 1 second to forced vital capacity ratio)
FEV1/FVC
Time frame
initial and at visit 3 (baseline and week 12)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Universitari de Bellvitge
Lead sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborator
Chiesi España, S.A.U.
Collaborator
Source ClinicalTrials.gov
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