NCT01142947

Brief Summary

Inhaled corticosteroids (ICS) are considered first-line treatment for persistent asthma, yet little is known about the genetic factors that influence response to this therapy. This study seeks to quantify response to ICS therapy in African American and white patients, as well as look for genetic markers that predict treatment response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
362

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable 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

Study Start

First participant enrolled

October 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
22 days until next milestone

Results Posted

Study results publicly available

April 2, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

9.3 years

First QC Date

June 11, 2010

Results QC Date

January 10, 2019

Last Update Submit

March 11, 2019

Conditions

Asthma

Keywords

Inhaled corticosteroidsAsthmaPharmacogenomicsGenome wide association studyAdmixture mappingContinental population groups

Outcome Measures

Primary Outcomes (1)

  • Change in Asthma Control Test Score

    Patients will be treated with 6 weeks of inhaled beclomethasone diproprionate (BD) treatment and the change in Asthma Control Test (ACT) quantified. The composite ACT score measured at each time point ranged from 5-25 (with higher scores reflective of better asthma control). Therefore, the absolute change in ACT score from before to after treatment could range from -20 to +20.

    6 weeks

Study Arms (1)

beclomethasone dipropionate (BD)

OTHER

Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in pulmonary function and asthma control. These change will be used as phenotypes in a genetic association study. There is no placebo group.

Drug: beclomethasone dipropionate

Interventions

beclomethasone dipropionateDRUG

160 mcg twice a day (320 mcg per day total)

beclomethasone dipropionate (BD)

Eligibility Criteria

Age12 Years - 56 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 12-56 years
  • Physician diagnosis of asthma (identified by using encounter data prior to screening and by the survey administered at the clinic visit)
  • Bronchodilator reversibility on pulmonary function testing (i.e., improvement in baseline FEV1 of \>12%)
  • African-American/Black self-reported race-ethnicity

You may not qualify if:

  • Smoking in the preceding year or \<10 pack-year smoking history total
  • Pregnant at the time of enrollment or intending to get pregnant during the 6-week treatment period
  • Oral or inhaled corticosteroid use in the 4 weeks preceding enrollment
  • Prior diagnosis of chronic obstructive pulmonary disease or emphysema
  • Prior diagnosis of congestive heart failure
  • Self-reported race not African-American/Black or Hispanic ethnicity (these groups could be included in Replication/Validation group)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Levin AM, Gui H, Hernandez-Pacheco N, Yang M, Xiao S, Yang JJ, Hochstadt S, Barczak AJ, Eckalbar WL, Rynkowski D, Samedy LA, Kwok PY, Pino-Yanes M, Erle DJ, Lanfear DE, Burchard EG, Williams LK. Integrative approach identifies corticosteroid response variant in diverse populations with asthma. J Allergy Clin Immunol. 2019 May;143(5):1791-1802. doi: 10.1016/j.jaci.2018.09.034. Epub 2018 Oct 24.

    PMID: 30367910RESULT

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Results Point of Contact

Title
L. Keoki Williams, MD, MPH
Organization
Center for Individualized and Genomic Medicine Research, Henry Ford Health System
kwillia5@hfhs.org
313-874-5454

Study Officials

  • L. Keoki Williams, MD, MPH

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Discovery set for ICS treatment response biomarker analysis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 14, 2010

Study Start

October 1, 2007

Primary Completion

February 1, 2017

Study Completion

March 11, 2019

Last Updated

April 2, 2019

Results First Posted

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)