Chronic obstructive Pulmonary Disorder (COPD) affects over 300 million people worldwide and is the fourth leading cause of death across the globe according to a recent WHO report. Millions are affected each year, with the majority being middle-aged to older adults. Smoking is the primary cause of COPD, along with air pollution and chemical allergens as other notable causes. It is a progressive disease, which slowly but steadily impairs the elasticity and functionality of lung muscles and air sacs, causing difficulty in breathing (dyspnoea), wheezing, coughing, chest tightness and associated discomfort.
COPD causes significant damage to the lung muscles, bronchus and air sacs (alveolar sacs), hardening them, which impairs breathing. Drugs that are commonly used to treat this are collectively called bronchodilators which when introduced into the airway passage bind to specific receptors causing them to dilate, making it easy to breathe in and out. To date, the standard treatment option for COPD was a combination of fluticasone and salmeterol, until in September 2013 a new combination of indacterol and glycopyrronium was approved (according to a report by the European Medicine Agency). This was based on the results of two randomized clinical trials conducted in patients — the first involving individual doses of indacterol , glycopyrronium and a placebo, and the other being against a combination of fluticasone and salmeterol. The results were compared based on Forced Expiratory Volumes (FEV) after 26 weeks of treatment and favored the combination of indacterol and glycopyrronium. Even in grade-3 COPD patients with at least two flare ups in a year, there was a reduction of 10 – 12% after 64 weeks of treatment.
However, in February 2014, in an assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG) by the German Institute for Quality and Efficiency in Healthcare (IQWiG) it was stated that the added benefits of indacterol combined with glycopyrronium in grade 2 and 3 patients were only minor, and the effects were subject to change depending on the severity of the condition. This was concluded after a 6-month study was concluded involving 934 adults, with a combination of formoterol and tiotropium as a comparative therapy. The results, when arranged accordingly with the COPD Assessment Test (CAT) sheet showed only minor differences. Moderate exacerbations were marginally less in grade 3 patients treated with a combination of indacterole and glycopyrronium while there was no change in severe exacerbations in both cases. The only noticeable change was the Transition Dyspnoea Index (TDI), which measured the severity of breathing problems in patients. Those with grade 2 or 3 COPD with no more than 3 exacerbations showed lesser troubles in breathing when treated with indacterole and glycopyrronium .
Since the severity of the disease acted as the “effect modifier” in this case, further clinical trials and more conclusive results would be needed in order to emphasize the added benefits of the combination of indacterole and glycopyrronium over other standards for COPD treatment.