Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthma
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Asthma |
| Therapuetic Areas: | Otolaryngology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | January 2006 |
| End Date: | July 2008 |
Double Blind Study to Determine Effect of Omalizumab Treatment in Patients With the Co-Morbid Conditions of Aspirin Exacerbated Respiratory Disease(AERD) and Allergic Asthma and Rhinitis.
Double blind protocol treatment of 2/3 of the patients with omalizumab and 1/3 placebo
administer for 4 months. Patients selected for the study must have both aspirin exacerbated
respiratory disease and allergic asthma and rhinitis. They must also have completed aspirin
desensitization and be taking aspirin on a daily basis for the treatment of AERD.
administer for 4 months. Patients selected for the study must have both aspirin exacerbated
respiratory disease and allergic asthma and rhinitis. They must also have completed aspirin
desensitization and be taking aspirin on a daily basis for the treatment of AERD.
60 patients with Aspirin Exacerbated respiratory Disease will be screened to determine if
they also have allergic respiratory tract disease as a co-morbid complication. This will
involve history, allergy skin tests and a serum IgE level. They must also have been
desensitized to aspirin and be taking aspirin 325 or 650 mg morning and night.
40/60 patients will receive omalizumab injections every month for the next 4 months and the
other 20 patients, via a random program, will receive placebo injections.
Monthly visits with the nurse co-ordinator will involve the following assessments: daily
symptom scores, daily use of medications (particularly prednisone and rescue albuterol
inhalers), lung function tests, nasal breathing test, measurement of smell and quality of
life scores pre and post study.
they also have allergic respiratory tract disease as a co-morbid complication. This will
involve history, allergy skin tests and a serum IgE level. They must also have been
desensitized to aspirin and be taking aspirin 325 or 650 mg morning and night.
40/60 patients will receive omalizumab injections every month for the next 4 months and the
other 20 patients, via a random program, will receive placebo injections.
Monthly visits with the nurse co-ordinator will involve the following assessments: daily
symptom scores, daily use of medications (particularly prednisone and rescue albuterol
inhalers), lung function tests, nasal breathing test, measurement of smell and quality of
life scores pre and post study.
Inclusion Criteria:
aspirin exacerbated respiratory disease and allergic asthma
Exclusion Criteria:
- pregnant females,starting immunotherapy in the past 3 months, prior treatment with
Xolair, negative allergy skin tests,unable to participate in lung function tests,
unable to complete data forms,low platelets, serum IGE greater than 700
iu,cancer,another uncontrolled medical condition, unacceptable concomitant
medication, under the age of 18 years.
We found this trial at
1
site
Click here to add this to my saved trials
