(Kai Stachowiak, Pixabay)
4 April 2017. Results from a year-long clinical trial show that an inhaler with three types of drugs reduces the number of COPD attacks compared to a common single-drug inhaler. Findings from the trial, led by researchers from University of Manchester in the U.K., appear in the 3 April issue of the journal The Lancet (paid subscription required).
Chronic obstructive pulmonary disease, or COPD, is a progressive respiratory disorder that makes it difficult to breathe, and causes coughing, wheezing, shortness of breath, and tightness in the chest. The leading cause of COPD is cigarette smoking, but other irritants like chemical fumes or air pollution can contribute to the condition.
Two major forms of the disease are emphysema, where walls between air sacs in the lungs are damaged and chronic bronchitis,where the lining of the airways is constantly irritated and inflamed. COPD is a major cause of disability and the third leading cause of death in the U.S. In the U.K., according to Manchester respiratory medicine professor Jørgen Vestbo who led the research team, COPD exacerbations, or attacks, lead to some 150,000 hospital admissions and 1.2 million bed-days each year.
The clinical trial tested a new type of inhaler designed to deliver drugs directly to the lungs for people with COPD. In this case, the inhaler — made by Chiesi Farmaceutici SpA in Parma, Italy that funded the study — delivers three different drugs to prevent COPD exacerbations: beclometasone, formoterol, and glycopyrrolate. Most of the total sample of nearly 3,700 participants with COPD, age 40 and over, were randomly assigned to test the triple-drug inhaler, used once a day, against a commonly used inhaler with a single drug, tiotropium.
A sub-group of participants, about 500, tested the triple-drug inhaler against a scenario where patients were asked to use two inhalers, one with combination of beclometasone and formoterol, and one with tiotropium. Participants in all groups were asked to use their inhalers for a whole year, where the study team looked primarily at the rate of moderate to severe exacerbations as the main indicator of effectiveness. Researchers also measured forced expiratory volume in 1 second, an indicator of lung performance, and tracked adverse effects.
The results show participants using the triple-drug inhaler had an exacerbation rate of 0.46 compared to 0.57 for tiotropium-only inhalers, a difference large enough to be statistically reliable. After a year, triple-drug inhaler users also had higher forced expiratory volumes than individuals with tiotropium-only inhalers. Exacerbation rates and lung performance were comparable for the triple-drug inhaler and dual-drug plus tiotropium samples; that part of the study looked for equivalence of the treatments, not superiority of one over the other.
Adverse effects rates for all of the inhalers were similar, but high. Between 55 and 58 percent of participants reported some type of adverse effects during the study.
Chiesi Farmaceutici submitted the triple-drug inhaler for approval by the European Medicine Agency in September 2016. The company says it’s the first triple-drug inhaler to seek approval for COPD.
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