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New treatment option for COPD Bronchitis
Official title Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
ClinicalTrials.gov ID: NCT06571942
What this study is testing
What is Vilanterol / Umeclidinium (25/62.5 mcg)?
Vilanterol / Umeclidinium (25/62.5 mcg) is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for copd bronchitis.
Also referred to as ANORO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 85, women only
You may be able to join if
- Subject capable of understanding instructions and giving her consent for participation.
- Diagnosis of COPD or chronic bronchitis without obstruction due to biomass smoke exposure:
- Diagnosis of COPD according to GOLD guidelines 2023 with: \>100 hours-year of biomass exposure index, and with a post-bronchodilator spirometry FEV1...
- Diagnosis of Chronic Bronchitis without obstruction with at least \>100 hours-year of biomass smoke exposure index or more than 10 years of continued...
- Able to attend all visits.
You likely can't join if
- 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...
- Patients with suspicion or history of cancer.
- Uncontrolled diseases: acute hyperthyroidism, acute uncontrolled DM2, acid-peptic disease that causes bleeding, uncontrolled hematological diseases...
See the full eligibility 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:
- 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...
- Able to attend all visits.
- Cooperative patients with adequate understanding and skill in using inhalers, or with caregivers capable of administering medications and filling out a daily symptom diary.
- Stable patients, with no history of exacerbations in the last 4 weeks before inclusion.
- 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...
- Patients with suspicion or history of cancer.
- Uncontrolled diseases: acute hyperthyroidism, acute uncontrolled DM2, acid-peptic disease that causes bleeding, uncontrolled hematological diseases, etc. In general, any decompensated disease that, in the opinion of the...
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Tlalpan, Mexico
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 35 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Tlalpan, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.