Trial Outcomes & Findings for Effect of Anti-IgE in Non-Allergic Asthma (NCT NCT00162773)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

baseline to 2 weeks

Results posted on

2017-08-28

Participant Flow

The arms/groups were combined for the study due to the study's early termination and the PI's departure from the institution. Data obtained were from the IRB and are therefore not separated by arm. This is all that is available.

Participant milestones

Participant milestones
Measure	All Participants water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE. OR Other Names: Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks
Overall Study STARTED	29
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE. OR Other Names: Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks
Overall Study P.I, Left institution. Study terminated	22

Baseline Characteristics

Effect of Anti-IgE in Non-Allergic Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=29 Participants water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE. OR Other Names: Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks omalizumab: 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.
Age, Customized >=18 and <=80	29 Participants n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Region of Enrollment United States	29 Participants n=93 Participants

PRIMARY outcome

Timeframe: baseline to 2 weeks

Population: Data, if any, are not available as this study has been terminated as the PI has left the institution. The arms/groups were combined for the study due to the study's early termination and the PI's departure from the institution. Data obtained were from the IRB and are therefore not separated by arm. This is all that is available.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=29 participants at risk water injection/Placebo: 150-375 milligrams depending on body weight and serum IgE. OR Xolair/Omalizumab 150-375 milligrams administered by subcutaneous injection every 2-4 weeks depending on body weight and serum IgE.
Infections and infestations Boil/Abscess/Cellulitis	3.4% 1/29 • Number of events 1 • The arms/groups were combined for the study due to the study's early termination and the PI's departure from the institution. Data obtained were from the IRB and are therefore not separated by arm. This is all that is available.

Additional Information

Clinical Trials Program JHU ICTR

Johns Hopkins University School of Medicine

Phone: 410-550-6484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place