Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
Recruiting
Phase 4
Interventional Study
COPD Bronchitis
Pollution Related Respiratory Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 35 – 85
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 128 (estimated)
- Sponsor
- National Institute of Respiratory Diseases, Mexico · Government
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subject capable of understanding instructions and giving her consent for participation.
* Diagnosis of COPD or chronic bronchitis without obstruction due to biomass smoke exposure:
1. Diagnosis of COPD according to GOLD guidelines 2023 with: \>100 hours-year of biomass expo…
Contacts
Rogelio Pérez-Padilla, Dr
+52 55 54 87 17 00
CONTACT