Efficacy and Acute Effects on Walked Distance froM basEline and Post Dose of indacateRol vs Tiotropium in Women With modeRAte to Severe COPD Secondary to Biomass Exposure: Open Label Crossover Clinical Trial

Background: Until now, COPD secondary to biomass exposure is treated in similar way that COPD due to tobacco smoke. Unfortunately none of the clinical trial included patient with biomass exposure in their multicenter studies. COPD due to biomass exposure is very common in Mexico and in other sub-developed countries, and represent a high economy burden similar as the tobacco exposure. In Mexico, in a reference center of COPD (National Institute of Respiratory Disease) thirty percent of women who attended with COPD has only the antecedent to cook with biomass. These patients have a predominant airway component, rather than emphysema. These patients have chronic bronchitis as a main clinical picture and in consequence, more exacerbations. Additionally, they present more symptoms such as dyspnea, and as COPD secondary to tobacco exposure, the functional and inspiratory capacity are reduced. There are previous studies that described the acute effects of long acting bronchodilators like salmeterol on functional and inspiratory capacity. However, they were done in patients with COPD secondary to tobacco smoke and there are not studies done in patients with COPD secondary to biomass exposition. Indacaterol a novel long-acting bronchodilator provide 24 h bronchodilation on once-daily dosing with a fast onset of action. Assuming the conditions of patients with COPD secondary to biomass exposure (women, rural or suburban origin, etc.) it is necessary strategies that enhance the adherence. There is information about better adherence with the least frequency of a drug. Tiotropium provide 24 h bronchodilation on once-daily dosing with a slow onset of action, it was selected because it is widely used in the treatment of COPD and is the only drug of the therapeutic class (long acting antimuscarinic bronchodilator) available in the market.

Until now there is no international nor national reported experience with any bronchodilators in COPD secondary to biomass.

This will be the first clinical trial in the world that attempts to evaluate the acute effects (fast onset action) of those two long acting bronchodilators, in women with COPD secondary to biomass exposure. Besides, the results will help to highlight the need in the rest of the world to include these patients in the different multicenter studies.

Primary objective:

To compare changes in walked meters from baseline six minute walking test (6MWT) to 23:45 hours after one dose of Indacaterol (150µg) vs Tiotropium (18µg) in patients with moderate to severe COPD secondary to biomass exposure.