NCT00133042

Brief Summary

The purpose of this study is to determine whether the addition of omalizumab in patients with poorly controlled asthma (because of poor adherence) will decrease allergic airway inflammation and improve asthma control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Dec 2004

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

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

September 20, 2011

Status Verified

February 1, 2009

Enrollment Period

2 years

First QC Date

August 19, 2005

Last Update Submit

September 16, 2011

Conditions

Asthma

Keywords

anti-IgE, omalizumab

Outcome Measures

Primary Outcomes (1)

  • adenosine, PC20, forced expiratory volume in one second (FEV1)

Interventions

omalizumabDRUG

Eligibility Criteria

Age6 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Non-smoking subjects
  • years of age
  • Evidence of poor asthma control
  • Adherence to ICS \< 50% of doses prescribed over a minimum of 3 months
  • Baseline FEV1 \> 60% of predicted
  • PC20 AMP \< 60 mg/ml
  • Able to perform American Thoracic Society (ATS)-acceptable and reproducible spirometry

You may not qualify if:

  • Cigarette smoking/use of marijuana
  • Pregnancy
  • Respiratory infections in past six weeks
  • History of acute allergic reaction to asthma/allergy medication
  • Total dose requirement of omalizumab more than 375 mg every two weeks
  • Inability to withhold required medications before challenge
  • Abnormal electrocardiogram (ECG)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Asthma Research Lab

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Hendeles L, Khan YR, Shuster JJ, Chesrown SE, Abu-Hasan M. Omalizumab therapy for asthma patients with poor adherence to inhaled corticosteroid therapy. Ann Allergy Asthma Immunol. 2015 Jan;114(1):58-62.e2. doi: 10.1016/j.anai.2014.10.012.

    PMID: 25528738DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Leslie Hendeles, PharmD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

December 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 20, 2011

Record last verified: 2009-02

Locations

US(1)