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

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 proportion of patients with COPD secondary by biomass exposure vary between 20-30%, depending on what kind of study and population, which is an important number leading to a great mortality, morbidity, social and economic, being important to characterize in a better way several relevant aspects such as the long period treatment response.

The proportion of patients with COPD by BE presents major proportion of phenotype "bronchitis" with major condition of peripheral airways level, with major proportion of dyspnoea and a decrease in the quality of life. It is precisely in these aspects where have been demonstrated benefits with ultra long-acting bronchodilators, as consequence, it is expected that this group of patients will be benefitted equal and perhaps in greater magnitude that those that are encompassed in the "emphysematous" phenotype.

Additionally, it is well described that the sub-diagnostic and sub-optimum treatment in patients with COPD in first level; because this kind of patients generally have low social-economic status and assuming that in the first level they will find the principal attention, it would be important to define major therapeutic alternatives in them.

As it was mentioned before, the exercising capacity is a functional outcome deeply studied with prognostic capacity in patients with COPD secondary to smoking; it is probably that it could be an outcome with major impact in this special group of patients (COPD secondary to biomass exposure), because they live, in general, in rural areas, heads of household and therefore, in terms of social rolls their functionality requirement is higher.

Finally, there is a finding well described the low adherence to patient's treatment with COPD, with various reasons including low economic resources and others such as devices of complicated application, multiple dosage, etc. Due to the fact that most of the people who suffer COPD by biomass exposure are women dedicated to housework all the day, it is probable that this kind of medicines (dosage once a day) as well as free treatment, is a strategy that improves the treatment adherence and could represent an improvement in the important outcomes in this devastating disease (functional capacity, quality of life, frequency of exacerbations, mortality).

Inclusion criteria

• Age: 50-80 years
• Female (female eligibility criteria are: Women in no fertile age who are non pregnant and committed to use effective contraception).*See note.
• 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).
• Be able to assist at all the study visits.
• Informed consent signed.
• Be able to perform the functional pulmonary test satisfactorily.
• Without any contraindication to perform any functional pulmonary test or exercise ( six-minute walking test.
• Stable COPD (No history of exacerbations in the last 6 weeks previous to the inclusion).
• Smoking index less than 5.
• If the subject is chronic - degenerative diseases associated, these must be controlled.
• 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.

• Women with at least 5 years with amenorrhea (postmenopause).

Exclusion criteria

• 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.
• Patients of childbearing age who do not agree to use effective methods of contraception.
• Patients with suspected cancer at any level.