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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
63 Participants
are grouped into 3 trial groupsSponsors and collaborators
Hospital Universitari de Bellvitge
Lead sponsor
Institut d'Investigació Biomèdica de Bellvitge
Collaborator
Chiesi España, S.A.U.
Collaborator
Source ClinicalTrials.gov