Trial Outcomes & Findings for Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization (NCT NCT00555971)

NCT ID: NCT00555971

Last Updated: 2020-11-03

Results Overview

Lack of Respiratory reaction during aspirin desensitization, including Spirometry (FEV1) testing, to assess the efficacy of Xolair on attenuating aspirin induced bronchospasm in patients with AERD.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2020-11-03

Participant Flow

Patients seen for evaluation and management for suspected AERD

16 subjects signed consent but only 13 were randomized 2 were screen fails and 1 lost to follow up

Participant milestones

Measure	Placebo Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis	Omalizumab Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis
Overall Study STARTED	5	8
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Placebo Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis	Omalizumab Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis
Overall Study Adverse Event	1	1

Baseline Characteristics

Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitization

Baseline characteristics by cohort

Measure	Placebo n=4 Participants Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis	Omalizumab n=7 Participants Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis	Total n=11 Participants Total of all reporting groups
Age, Continuous	41.8 years STANDARD_DEVIATION 7.2 • n=5 Participants	45.7 years STANDARD_DEVIATION 11.9 • n=7 Participants	44.3 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
FEV1 Percent predicted	90.0 Percent predicted STANDARD_DEVIATION 18.5 • n=5 Participants	92.6 Percent predicted STANDARD_DEVIATION 14.4 • n=7 Participants	91.6 Percent predicted STANDARD_DEVIATION 16.8 • n=5 Participants
IgE IU/ml	64.6 IU/ml STANDARD_DEVIATION 36.6 • n=5 Participants	120.5 IU/ml STANDARD_DEVIATION 76.7 • n=7 Participants	100.3 IU/ml STANDARD_DEVIATION 73.9 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Lack of Respiratory reaction during aspirin desensitization, including Spirometry (FEV1) testing, to assess the efficacy of Xolair on attenuating aspirin induced bronchospasm in patients with AERD.

Outcome measures

Measure	Placebo n=4 Participants Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis	Omalizumab n=7 Participants Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis
Number of Participants Without Respiratory Reaction During Aspirin Desensitization	0 Participants	5 Participants

SECONDARY outcome

Timeframe: Approximately 24 weeks

Measurements of urinary LTE4 in association with aspirin desensitization, comparing subjects randomized to placebo with subjects randomized to omalizumab, with study drug administered for 16 weeks. Measurements were compared for respiratory reaction in placebo subjects who exhibited either upper or lower airway reaction and after 100 mg aspirin challenge dose in omalizumab subjects who were non-reactors. For this analysis, the two omalizumab subjects who had respiratory reaction were not included.

Outcome measures

Measure	Placebo n=4 Participants Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis	Omalizumab n=5 Participants Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis
Measurements of Urinary LTE4 in Association With Respiratory Reaction During Aspirin Desensitization	17489 pg/mg creatinine units Standard Error 7102	1852 pg/mg creatinine units Standard Error 280

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Omalizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=4 participants at risk Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. placebo: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis	Omalizumab n=7 participants at risk Subjects with aspirin exacerbated respiratory disease enrolled and randomized to either omalizumab or placebo (2:1) in a blinded fashion, administered for 16 weeks. The study is double-blind. Omalizumab: aspirin desensitization will be carried out for all subjects with aspirin exacerbated respiratory disease who participate in the study, with subjects randomized 2:1 to receive either omalizumab or placebo, which will allow us to evaluate the study hypothesis
Gastrointestinal disorders Aspirin intolerance	25.0% 1/4 • Number of events 1 • Entire study until last randomized subject completed participation, approximately 24 weeks	0.00% 0/7 • Entire study until last randomized subject completed participation, approximately 24 weeks

Additional Information

David M. Lang

Cleveland Clinic

Phone: 216-444-6933

Email: langd@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place