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Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma.

Raphael, Gordon; Taveras, Herminia; Iverson, Harald; O'Brien, Christopher; Miller, David.
J Asthma; 53(2): 187-93, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26369589

OBJECTIVE:

Evaluate the safety of albuterol multidose dry powder inhaler (MDPI), a novel, inhalation-driven device that does not require coordination of actuation with inhalation, in patients with persistent asthma.

METHODS:

We report pooled safety data from two 12-week, multicenter, randomized, double-blind, repeat-dose, parallel-group studies and the 12-week double-blind phase of a 52-week multicenter safety study as well as safety data from the 40-week open-label phase of the 52-week safety study. In each study, eligible patients aged ≥ 12 years with persistent asthma received placebo MDPI or albuterol MDPI 180 µg (2 inhalations × 90 µg/inhalation) 4 times/day for 12 weeks. In the 40-week open-label phase of the 52-week safety study, patients received albuterol MDPI 180 µg (2 inhalations × 90 µg/inhalation) as needed (PRN).

RESULTS:

During both 12-week studies and the 12-week double-blind phase of the 52-week study, adverse events were more common with placebo MDPI (50%; n = 333) than albuterol MDPI (40%; n = 321); most frequent were upper respiratory tract infection (placebo MDPI 11%, albuterol MDPI 10%), nasopharyngitis (6%, 5%), and headache (6%, 4%). Incidences of ß2-agonist-related events (excluding headache) during the pooled 12-week dosing periods were low (≤ 1%) in both groups. The safety profile with albuterol MDPI PRN during the 40-week open-label phase [most frequent adverse events nasopharyngitis (12%), sinusitis (11%), upper respiratory tract infection (9%)] was similar to that observed during the 12-week pooled analysis.

CONCLUSIONS:

The safety profile of albuterol MDPI 180 µg in these studies was comparable with placebo MDPI and consistent with the well-characterized profile of albuterol in patients with asthma.
Selo DaSilva