Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
Chronic Obstructive Pulmonary Disease (COPD) is a disease that produces a high rate of social
and economic health mortality and morbidity not only in our country but in the international
field. The causes of this disease are well-known, being smoking what produces the major
portion and the less (but no less important) frequently, biomass exposure (when people cook
or warm the house). It is described that the COPD secondary to biomass exposure it is
approximately a third half of all the cases in cohorts in patients with this disease.
Patients clinical affection with COPD by biomass is different from the one described in
patients by smoking, being the most frequent the affection peripheral airway, with major
proportion of symptoms such as dyspnoea, cough and expectoration (Phenotype "chronic
bronchitis"), major frequency of exacerbations, as well as, major affection in the quality of
life related to health and a minimum emphysema proportion.
Currently, there is a trend of paying attention on the outcomes based on patients, such as
symptoms, quality of life and the risk prevention (exacerbations) as it is exposed in the
strategy GOLD 2011. In that way, the bronchodilators use as a pillar in the COPD due to the
utility for the exacerbation prevention, symptomatic improvement and in quality of life,
predominating the utility of ultra long-acting bronchodilators, such as tiotropium. Recently,
it is available more information on new bronchodilators as indacaterol, demonstrating at
least no inferiority effect on FEV1, inspiring capacity (in fact, discreet superiority on the
last one) and symptoms. A functional outcome clinically important is the capacity of
exercising; Six-Minute Walk Test (6MWT) has been widely used to predict prognosis of COPD
secondary to smoking. This test has not been evaluated in predicting the response to the
specific treatment in patients with COPD secondary to biomass exposure.
Long-acting bronchodilators have been demonstrated a benefit to the patients with COPD by
smoking, in the exercising capacity measured by 6MWT. There are several reasons why this
outcome could be more relevant especially in this population: inhabit in rural areas where
people walk long distances, most of them are women and they are usually in charge of all the
housework.
Almost all the studies reported until now exclude patients with COPD due to some cause other
than smoking. Due to the lack of information on this item and the particularities in this
clinical and functional characteristics observed in this kind of patients, it is considered
that these patients will be benefit with the use of ultra long-acting bronchodilators, to
long period and, potentially can be observed additional benefits in the decrease of the
frequency of the exacerbations and symptomatology as well as other important outcomes such as
the functional, respiratory capacity among others.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Respiratory Diseases, Mexico