NCT00139152

Brief Summary

The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

4.3 years

First QC Date

August 29, 2005

Last Update Submit

January 6, 2014

Conditions

Lung Disease

Keywords

moderate to severe allergic asthma

Outcome Measures

Primary Outcomes (1)

  • To assess the effect of Xolair on exhaled nitric oxide and leukotriene levels obtained from exhaled breath condensate in patients before and after four months of Xolair or placebo treatment.

    post dose

Secondary Outcomes (1)

  • To measure the levels of power of hydrogen (pH), nitrate/nitrite in exhaled breath condensate before and after four months treatment with Xolair and to compare these data to those obtained from the placebo asthmatic control group.

    post dose

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline placebo

Drug: Placebo

Xolair

EXPERIMENTAL

Xolair treatment

Drug: Xolair

Interventions

PlaceboDRUG

Saline, Sub-Cuteanous (SQ)

Also known as: Normal Saline
Placebo
XolairDRUG

Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ

Also known as: omalizumab, rhumabE25
Xolair

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • On medium to high dose inhaled corticosteroids either with or without a long acting beta agonist
  • Baseline IgE 30-700 IU/mL
  • Exhaled nitric oxide greater than 13 ppb
  • Positive skin test to at least one of the following perennial allergens: cat, dog, dust mite, cockroach
  • Stable asthma at the time of enrollment

You may not qualify if:

  • Concurrent diseases/conditions, history of other diseases/conditions, with clinically significant uncontrolled systemic disease or a history of such disease (eg, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinological, or gastrointestinal disease) within previous 3 months
  • Upper or lower respiratory tract infection within 6 weeks of screening visit
  • Elevated IgE level other than atopy
  • Known sensitivity to Xolair
  • \< 3 months of stable immunotherapy
  • Smokers
  • Pregnant/nursing women
  • Women of childbearing potential who are not practicing medically approved contraceptive methods (eg, oral, subcutaneous, mechanical, or surgical contraception) including abstinence
  • Patients who currently hav diagnosed cancer, are currently being investigated for possible cancer or who have any history of cancer
  • Known sensitivity to study drug or class of study drugs
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Use of any other investigational agent in the last 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Creighton University Division of Allergy & Immunology

Omaha, Nebraska, 68131, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

Saline SolutionOmalizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAntibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Robert G Townley, MD

    Creighton University Division of Allergy & Immunology

    PRINCIPAL INVESTIGATOR

  • Muhammad A Pasha, M.D.

    Albany Medical CollegeDivision of Allergy, Asthma, & Immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

US(2)