Efficacy in Walked Distance of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass (EMERALD)

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Chronic Obstructive Pulmonary Disease (COPD) secondary to biomass exposure constitutes a chronic respiratory condition frequently excluded from large clinical trials. Biomass exposure COPD have some histopathologic, clinical, radiological and functional differences with tobacco smoke COPD. However, until now, there are no evidence in this patients about the clinical response to bronchodilators routinely used in tobacco smoke COPD.

Primary objective: To compare changes in walked meters from baseline on six minute walking test (6MWT) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate to severe COPD secondary to biomass exposure.

Secondary objectives: To compare changes in pulmonary function (inspiratory capacity, Forced Expiratory Volume in first second (FEV1) milliliters, FEV1 "through") from baseline (-10 minutes) to 23:45 hours after one dose of indacaterol vs tiotropium in patients with moderate to severe COPD secondary to biomass exposure.

This will be an open label study, double blinded, cross over and conducted at specialized respiratory care center (National Institute of Respiratory Diseases), to compare the acute effects of ultra long acting bronchodilators used in tobacco smoke exposure COPD. Unicentric study.

Ethics Committee approbation: C 22-12

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Respiratory Diseases, Mexico
• Treatments: Tiotropium Bromide

Criteria

Inclusion Criteria:

1. Mexican patients at the COPD outpatient clinic

2. Age: >50

3. Female (female eligibility criteria are: Women in no fertile age who are non pregnant and committed to use effective contraception).

4. FEV1 less than 80% of predicted and risk of exacerbation (GOLD update 2011) B, C or D

5. Women with COPD diagnostic with biomass exposition (defined with an Hours/years index >200 hr/y).

6. Be Able to assist at the different visits during the study.

7. Be Able to performed the spirometry

8. Patients without contraindications to perform the six-minute walk test.

9. Informed consent signed.

10. No history of exacerbations in the last 6 weeks previous to the inclusion.

11. With amenorrhea history more than a year duration.

Exclusion Criteria:

1. Pregnant or breastfeeding women

2. Use of Methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants,

3. History of uncontrolled renal disease, liver disease, uncontrolled cardiovascular disease, metabolic disease, neurologic disease, hematologic disease, oncologic disease, or autoimmune disease.

4. Any alteration in normal values of the following Laboratory test: liver test, PIE, Biochemistry tests.

5. History of asthma, bronchiectases, tuberculosis, recent respiratory tract infection, were hospitalized for a COPD exacerbation (6 weeks prior to visit 1), any significant pulmonary disease o cardiovascular abnormality

6. Patients that is under suspicion of having cancer.