N/A
Completed N=14,124
Drug Utilization Study for Olodaterol
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03030638 ↗
Enrolled (actual)
14,124
Serious AEs
—
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Off-label Use of Olodaterol Among New Users — 48.6; 19.6; 30.3; 33.9 Percentage of participants
Summary
This study aims to characterise the use of single-agent olodaterol and single-agent indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic obstructive pulmonary disease (COPD), but not for asthma, in clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Off-label Use of Olodaterol Among New Users |
48.6; 19.6; 30.3; 33.9; 17.3; 3.5 | — |
| PRIMARY Baseline Characteristics of New Users of Olodaterol: Age |
68; 71; 63; 67 | — |
| PRIMARY Baseline Characteristics of New Users of Olodaterol: Gender |
702; 977; 322; 129; 684; 735 | — |
| SECONDARY Percentage of Off-label Use of Indacaterol Among New Users |
61.1; 29.2; 66.6; 34.9; 20.5; 3.5 | — |
| SECONDARY Baseline Characteristics of New Users of Indacaterol: Age |
67; 69; 63; 68 | — |
| SECONDARY Baseline Characteristics of New Users of Indacaterol: Gender |
887; 3324; 696; 42; 954; 3082 | — |
Eligibility Criteria
Inclusion criteria
- receive a first prescription/dispensing for single-agent formulations of olodaterol or indacaterol during the study period (no prescriptions/dispensings ever before)
- patients must have at least 12 consecutive months of enrolment in the database before the index date
Exclusion criteria
- Individuals with missing or implausible values for age or sex will be excluded.
Data sourced from ClinicalTrials.gov (NCT03030638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.