NCT02045875

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 4, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2017

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 20, 2018

Completed
Last Updated

June 20, 2018

Status Verified

February 1, 2018

Enrollment Period

3.3 years

First QC Date

January 23, 2014

Results QC Date

May 11, 2018

Last Update Submit

June 19, 2018

Conditions

Asthma

Keywords

Adherence monitoringMotivational Interviewing Adherence strategies

Outcome Measures

Primary Outcomes (1)

  • Asthma Control

    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, one, two and three months

Secondary Outcomes (2)

  • Adherence to Dulera 100/5 and 200/5

    week 2. months 1, 2, and 3

  • Overall Adherence to Dulera 100/5 and 200/5

    3 months

Study Arms (2)

Dulera adherence monitoring

EXPERIMENTAL

Adherence Monitoring Dulera; Identification of adherence barrier(s); Motivational Interviewing Adherence Strategies to promote adherence

Drug: Dulera

Dulera Standard of Asthma Care

ACTIVE COMPARATOR

Dulera standard of asthma care

Drug: Dulera

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.

Also known as: mometasone furoate/formoterol fumarate dihydrate
Dulera Standard of Asthma CareDulera adherence monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician diagnosis of asthma of moderate severity
  • Subjects ≥ 18 years of age
  • Currently receiving an inhaled corticosteroid medication and being prescribed Dulera 100/5 as part of standard of care based upon asthma severity and dosing guidelines
  • Asthma Control Questionnaire (ACQ) result \> 1.0 at entry
  • Demonstration of correct inhalation technique for use of meter-dosed inhalers (MDIs)

You may not qualify if:

  • Intermittent asthma (asthma exacerbations or symptoms \< 3 days/week)
  • Diagnosis of emphysema in prior year
  • Diagnosis at any time of: chronic obstructive pulmonary disease (COPD), chronic bronchitis, cystic fibrosis, bronchiectasis, Churg Strauss, Wegener's, sarcoidosis, pulmonary hypertension or lung cancer
  • On any medication documented to have a drug interaction with Dulera

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Penn Allegheny Health System

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate, Formoterol Fumarate Drug CombinationMometasone Furoate

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Andrew G Weinstein MD
Organization
Asthma Management Systems
agwmd@aol.com
302 893 5455

Study Officials

  • Deborah Gentile, DO

    West Penn Allegheny Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 27, 2014

Study Start

March 4, 2014

Primary Completion

July 1, 2017

Study Completion

July 12, 2017

Last Updated

June 20, 2018

Results First Posted

June 20, 2018

Record last verified: 2018-02

Locations

US(1)