drugset / Trial / NCT02682862

Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics

NCT02682862 ↗

Phase 4 Completed 17 enrolled University of Dundee
RandomizedCrossoverOpen-labelTreatment

Summary

Single centre, open-label, random order, cross-over trial, recruited over a period of approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn subjects may be replaced. This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test called impulse oscillometry.

Timeline

Start
2016-07-11
Primary completion
2019-05-22
Completion
2019-05-22

Outcome

Met primary endpoint

paper For the primary end-point of total airway resistance (as R5), the mean difference (95%CI) at trough was 0.06 (0.015-0.10) kPa/l/s PMID 33180376 ↗

paper CONCLUSIONS: ICS/LABA/LAMA was superior to ICS/LABA on trough small airway outcomes in asthma patients who smoke. PMID 33180376 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Olodaterol Small molecule 2.5 ug Inhaled
Subject Tiotropium Other / unclassified 2.5 ug Inhaled

Indications