CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Duleradrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02045875
NCT02045875Phase 4Completed

Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence

Asthma Management Systems·interventional·Posted Jan 27, 2014·Updated Jun 20, 2018

In Brief

A Phase 4 clinical trial evaluating Dulera for Asthma. Completed, enrolled 50 participants across 1 site.

Detailed Summary

40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20, will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3 months. These intervention subjects will receive medication use feedback at each visit, while the control group will receive the standard of asthma care. Those interventional subjects with Dulera adherence\<60% will receive feedback based on an asthma adherence disease management model protocol, Asthma Adherence Pathway. Intervention clinicians will been trained in Motivational Interviewing to reduce subject ambivalence about medication use. The primary hypothesis is that subjects who receive medication monitoring and Motivational Interviewing adherence strategies will have better asthma control, as measured by the Asthma Control Questionnaire, than the control group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 27, 2014
Enrollment StartMar 4, 2014
Primary CompletionJul 1, 2017
Study CompletionJul 12, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.4 years ago

Interventions

Duleradrug

Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.