Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age35-85
SponsorNational Institute of Respiratory Diseases, Mexico
About this trial
This phase IV randomized controlled clinical trial intend to compare the effect of three close standard inhaled triple therapies and one close standard inhaled double therapy on the small airway in patients with Chronic Obstructive Pulmonary Disease (COPD-B) and chronic bronchitis without obstruction (BCNO) exposed to wood smoke. The treatment phase duration is of 3 months. As primary outcome, the resistance change in post-bronchodilatator impulse oscilometry will me measure at 30 minutes, 2 hours, 4 hours, and 24 hours post first dose of the asigned medication, and then at 1 and 3 months of treatment. As secondary outcomes, change in respiratory symptoms and health related quality of life will be assess after 1 and 3 months of treatment.
Eligibility criteria
Qualifiers
Subject capable of understanding instructions and giving her consent for participation.
Diagnosis of COPD according to GOLD guidelines 2023 with: >100 hours-year of biomass exposure index, and with a post-bronchodilator spirometry FEV1 > 70% of predicted value.
Diagnosis of Chronic Bronchitis without obstruction with at least >100 hours-year of biomass smoke exposure index or more than 10 years of continued exposure to biomass smoke, and with 1) antecedent of chronic bronchitis, and 2) post-bronchodilator spirometry FEV1/FVC >0.7.
Able to attend all visits.
Disqualifiers
Pregnancy or in the breastfeeding period.
Documented allergy or intolerance to any of the study medications.
History of clinically significant bronchiectasis, tuberculosis, recent respiratory infection (4 weeks), or cardiovascular comorbidity that contraindicates pulmonary function tests or that influences their status and functional class.
Patients with suspicion or history of cancer.
Trial design
Treatments tested in this trial
- Vilanterol / Umeclidinium (25/62.5 mcg)
- Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg)
- Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg
- Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov