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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Vilanterol / Umeclidinium (25/62.5 mcg)
DrugOne inhalation daily from Ellipta device for three months
Fluthicasone / Vilanterol / Umeclidinium (100/25/62.5 mcg)
DrugOne inhalation daily from Ellipta device for three months
Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg
DrugTwo inhalations twice daily form pMDI device for three months
Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg
DrugTwo inhalations twice daily form pMDI device for three months
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: COPD due to biomass exposureExperimental treatment 4 interventions
Group B: Chronic bronchitis without obstruction due to biomass exposureExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Change in impulse oscillometry
To quantify the change in impulse oscillometry (post-bronchodilator) change in total resistance measured in percentage change from baseline change R5-R20 and/or AX for the patients who used Vilanterol / Umeclidinium 25/62.5 mcg once daily = ANORO®; Fluthicasone / Vilanterol / Umeclidinium 100/25/62.5 mcg once daily= TRELEGY®; Beclomethasone / Formoterol / Glycopyrronyum 100/6/12.5 mcg; two inhalations twice daily = TRIMBOW®; and Budesonide / Formoterol / Glycopyrronyum 160/4.8/7.2 mcg two inhalations twice daily= TRIXEO®.
Time frame
3 monthsSecondary outcomes
1
Change of resistences in impulse oscillometry
Quantify the change in R5, R20, R5-R20 \[kPa/(L/s)\]
Time frame
30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months2
Change of resistences in impulse oscillometry
Quantify the change in Ax \[kPa/L\]
Time frame
30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months3
Change of total resistances in pletismography
Change in total resistances (kPa\*s/L), measured by plethysmography.
Time frame
30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 months4
Chance in lung function in spirometry
Change in FEV1, and FVC, both in liters.
Time frame
30 minutes, 2 hours, 4 hours, 24 hours, 1 month, 3 monthsSponsors and contacts
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Source ClinicalTrials.gov