NEW ORLEANS – Data collected by the ProAir Digihaler suggest .
Researchers studied asthma patients who had experienced exacerbations in the previous year. Patients who also had exacerbations while on study used the ProAir Digihaler about twice a day, on average. Patients without on-study exacerbations used the ProAir Digihaler an average of 1.14 times per day.
The daily use among patients without exacerbations suggests their asthma is “still quite uncontrolled,” and, according to guidelines, they may require additional therapy, said Roy Pleasants, PharmD, of the University of North Carolina at Chapel Hill.
Dr. Pleasants presented these findings at the annual meeting of the American College of Chest Physicians.
He and his colleagues conducted a phase 3 study () of ProAir Digihaler use in adults who had at least one severe clinical asthma exacerbation in the previous 12 months. They had an Asthma Control Questionnaire score of 1.5 or greater, were on moderate-dose inhaled corticosteroids (with or without a long-acting beta-agonist), and had stable asthma controller dosing for at least 3 months.
For this study, the ProAir Digihaler replaced patients’ other rescue medications. The ProAir Digihaler is a digital inhaler that delivers 90 mcg of albuterol per dose, detects the date and time a dose was prepared, and records the inhalation profile. Over a 12-week period, the ProAir Digihaler recorded each use, which was defined as consecutive inhalations within 60 seconds.
Of the 381 patients enrolled in the study, 360 (94.5%) made at least one valid inhalation. The mean age of these patients was 50 years, and 80.6% were female. Of the 360 patients, 64 experienced 78 exacerbations while on study.
Most episodes of inhaler use consisted of a single inhalation (58.9%), although 35.8% consisted of two inhalations, 3.5% consisted of three inhalations, and 1.8% consisted of four or more inhalations.
The mean peak inspiratory flow was 73.18 L/min (standard deviation [SD] 20.33) in patients without exacerbations. Among patients with exacerbations, the mean peak inspiratory flow was 71.36 (SD 23.80) during exacerbation and 74.71 L/min (SD 22.46) outside the exacerbation window, which was 14 days before and after the exacerbation peak.
The mean inhalation volume was 1.45 L (SD 0.75) among patients without exacerbations, 1.44 L (SD 0.66) outside the exacerbation window, and 1.44 L (SD 0.76) during exacerbation. The mean inhalation duration was 1.62 sec (SD 0.88), 1.59 sec (SD 0.77), and 1.61 sec (SD 0.82), respectively.
“If you look at the inhalation volume in the 64 patients who exacerbated, it really didn’t change during exacerbation,” Dr. Pleasants noted. “Essentially, you can say the same thing about inhalation duration.”
Patients without exacerbations used the ProAir Digihaler an average of 1.14 (SD 2.35) times per day. Patients who had at least one exacerbation used the ProAir Digihaler an average of 1.87 (SD 2.78) times per day outside the exacerbation window and 2.43 (SD 3.67) times during exacerbation.
“As you would predict, those exacerbating patients were using more albuterol than patients who were not exacerbating,” Dr. Pleasants said. “Even when they weren’t exacerbating, that frequency of daily albuterol use is pretty much indicating these patients were not so well controlled.”
Dr. Pleasants went on to say that data from the ProAir Digihaler could help identify, in real time, patients with poor asthma control and those with impending exacerbations.
This study was sponsored by Teva, makers of the ProAir Digihaler. Dr. Pleasants disclosed relationships with Teva, Grifols, Sunovion, and Boehringer Ingelheim.
SOURCE: Pleasants R et al. CHEST 2019.