For people with lung problems like COPD, taking a deep breath can be difficult without the help of an inhaler. But are those inhalers always safe?
Recently, researchers looked at a new mist inhaler to determine its safety compared with a dry powder inhaler currently used in the US.
The inhalers both use the same type of medication, but previous smaller studies have shown that the mist inhaler could increase the risk of death among users.
This new study, which was the largest and most comprehensive study on these COPD inhalers yet, showed that the mist inhalers did not increase the patient's risk of death compared to the older powder ones.
"Ask your doctor about inhaler options for COPD."
Robert Wise, MD, of Johns Hopkins University School of Medicine in Baltimore, Maryland, and several colleagues conducted this study to look at the safety of an inhaler in treating COPD, or chronic obstructive pulmonary disease.
COPD is a disease of the lungs characterized by the breaking down of lung tissue, leading to progressive shortness of breath and coughing.
COPD is usually caused by smoking tobacco and typically gets worse as the COPD patient gets older. Often, COPD patients use inhalers to help with breathing.
This study tested the safety of one drug, tiotropium, delivered in both mist and dry powder inhalers. Tiotropium (brand name Spiriva) is a medication that opens up the airways in the lungs to allow for better air flow.
Currently, the mist version of tiotropium, Respimat, is available in Europe and the dry powder, called the HandiHaler, is used in the US. Some previous small studies have called into question the safety of the new mist device.
The research led by Dr. Wise was a larger trial testing the safety of the Respimat device.
A total of 17,135 patients participated in this study, each of whom were over 40 years old and had been diagnosed with COPD. The participants also had a smoking history of at least 10 years.
These participants were split into three groups: one group received a daily dose of 2.5 micrograms delivered by the Respimat, another received a daily dose of 5 micrograms delivered by the Respimat and the third group received a dose of 18 micrograms (the typical dose) delivered by the HandiHaler.
The study participants used their treatment for about 835 days. They checked in for follow-up at local clinics about once every three months, then 30 days after the end of their treatment.
The researchers measured the risk of death associated with each of the inhalers.
During the course of the study, 7.4 percent percent of patients who were taking the Respimat 5 microgram dose died. Of the Respimat group taking the 2.5 microgram dose, 7.7 percent died. Of the HandiHaler group, 7.7 percent died. Causes of death included heart problems, stroke and breathing problems.
The researchers concluded that Respimat was not associated with a higher death rate than HandiHaler. Overall, they found no significant difference in death rates between those taking the Respimat 2.5 microgram dose, the Respimat 5 microgram dose and the HandiHaler 18 microgram dose of tiotropium.
Additionally, there was no difference in COPD exacerbations, or several days of worsening symptoms, associated with the medications.
“This was a much-awaited study, because previous, smaller studies had raised the question of whether there was an increased risk of death with the newer tiotropium device", said Dr. Wise in a press statement. “We needed a very large trial to answer the question.”
This study was published in The New England Journal of Medicine on August 30.
The research was funded by Boehringer Ingelheim, the Dr. Wise and other authors reported receiving consulting fees, lecture fees, and grant support from several pharmaceutical companies.