NCT02045875

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

Completed Phase 4 Results posted Last updated 20 June 2018

What this trial tests

Phase 4 trial testing Dulera in Asthma in 50 participants. Completed in 12 July 2017.

Timeline

4 March 2014

Primary endpoint
1 July 2017

12 July 2017

Quick facts

Lead sponsor	Asthma Management Systems
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	4 March 2014
Primary completion	1 July 2017
Estimated completion	12 July 2017
Sites	1 location across United States

Drugs / interventions tested

• Dulera — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Asthma Management Systems — full company profile →

Who can join

18 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Asthma Control Primary · Baseline, one, two and three months

Asthma Control Questionnaire measured at each office visit. ACQ integrates values by 6 clinical questions related to symptoms and the value related to FEV1% predicted with a total score ranging from 0-6 and higher values indicating poorer asthma control.

baseline

Group	Value	95% CI
Dulera Adherence Monitoring	1.857	± 0.924
Dulera Standard of Asthma Care	1.592	± 0.839

one month

Group	Value	95% CI
Dulera Adherence Monitoring	1.792	± 1.359
Dulera Standard of Asthma Care	1.578	± 0.855

two month

Group	Value	95% CI
Dulera Adherence Monitoring	1.345	± 1.184
Dulera Standard of Asthma Care	1.488	± 0.947

three month

Group	Value	95% CI
Dulera Adherence Monitoring	1.105	± 0.806
Dulera Standard of Asthma Care	1.407	± 0.759

Adherence to Dulera 100/5 and 200/5 Secondary · week 2. months 1, 2, and 3

Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark Adherence was calculated by taking the number of doses actually taken divided by the number of doses prescribed and multiplying by 100.

week 2

Group	Value	95% CI
Dulera Adherence Monitoring	88.75	± 10.43

month 1

Group	Value	95% CI
Dulera Adherence Monitoring	80.7	± 14.52

month 2

Group	Value	95% CI
Dulera Adherence Monitoring	77.55	± 19.13

month 3

Group	Value	95% CI
Dulera Adherence Monitoring	76.8	± 19.83

Overall Adherence to Dulera 100/5 and 200/5 Secondary · 3 months

Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark Overall interval value was the mean of daily percent

Group	Value	95% CI
Dulera Adherence Monitoring	80.95	± 14.23

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions to improve adherence to inhaled steroids for asthma.
   Normansell R, Kew KM, Stovold E. · · 2017 · cited 104× · PMID 28417456 · DOI 10.1002/14651858.cd012226.pub2