Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).
Full description
This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria applied to the study.
Primary purpose
Allocation
Interventional model
Masking
35 participants in 4 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal