Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure

Launched by NATIONAL INSTITUTE OF RESPIRATORY DISEASES, MEXICO · Aug 16, 2022

Keywords

ClinConnect Summary

The use of bronchodilators is an invaluable tool in COPD, in outcomes such as the exacerbation preventions, improvement of symptoms and exercise capacity and therefore in quality of life. However, as the efficacy as the security such as bronchodilators benefits that have only been characterized in patients with COPD secondary to smoking and it is only assumed benefits in COPD by other causes but without confirmation.

There are no national or international studies that describe the ultra long-acting bronchodilator's efficacy and security in COPD secondary to biomass exposure (BE).

The prop...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 50-80 years
• • 2. Female (female eligibility criteria are: Women in no fertile age who are non pregnant and committed to use effective contraception).\*See note.
• • 3. Relation FEV1/FVC less than 70% of predicted and the index obtained by the relation between the hours and the years of exposure (IEHL) more than 100 hrs/year (COPD of any grade or symptomatic).
• • 4. Be able to assist at all the study visits.
• • 5. Informed consent signed.
• • 6. Be able to perform the functional pulmonary test satisfactorily.
• • 7. Without any contraindication to perform any functional pulmonary test or exercise ( six-minute walking test.
• • 8. Stable COPD (No history of exacerbations in the last 6 weeks previous to the inclusion).
• • 9. Smoking index less than 5.
• • 10. If the subject is chronic - degenerative diseases associated, these must be controlled.
• • 11. II-III functional class that allow her assist to the study visits.
• • \*Note: This problem predominates in WOMEN, as gender and roles (predominately in rural areas) who are the ones that cook and are exposed enough time to appear the comorbidity associated (COPD, headache, backache, conjunctival irritation, etc). That is why in this study were included only women because this is a problem of gender and poverty.
• • 12. Women with at least 5 years with amenorrhea (postmenopause).
• Exclusion Criteria:
• 1. History of:
• • Allergy or known intolerance to any of the bronchodilator drugs in the study.
• • Asthma, bronchiectasis (as tuberculosis, whooping cough or other infection sequelae associated in the clinic history), tuberculosis, COPD recent exacerbation or acute respiratory infection.
• • Cardiovascular disease recent (less than 3 months) that contraindicate the functional pulmonary test.
• • 2. Patients of childbearing age who do not agree to use effective methods of contraception.
• • 3. Patients with suspected cancer at any level.