Pulmonary and cardiovascular safety of inhaled insulin in routine practice: The Exubera Large Simple Trial (VOLUME).

ABSTRACT:

Objective

VOLUME is a randomized, open-label, post-approval pragmatic trial aiming to evaluate long-term pulmonary and cardiovascular safety of Exubera® (EXU; insulin human [rDNA origin] Inhalation Powder) in routine clinical practice. The primary study objective is to compare risk of persistent decline in forced expiratory volume in 1 second (FEV₁) among patients treated with and without EXU.

Research design and methods

Patients eligible to take EXU per approved local label were randomized to EXU or routine care and followed per usual care, with scheduled FEV₁ tests at baseline, 6 months, and yearly.Randomization halted in October 2007 after Pfizer announced it would stop marketing EXU due to low sales. EXU patients were subsequently transitioned to us

SUBMITTER: Gatto NM 

PROVIDER: S-EPMC7251384 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature