Allergic AsthmaX-PANDNCT00813748

Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing

An observational study of Allergic Asthma, run by Genentech, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis. This is an observational repository and not an investigational clinical trial. Read more about this study

Who is it for?: Any age
Conditions the study is for: Allergic Asthma
What is being tested?: Xolair
How many people: 118 participants
Where: 7 sitesUnited States
Study dates: Mar 2009to Jan 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: primary care clinic

Who may be able to join

Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair
At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment
At least one dose of Xolair in the 18 months before the date of the case event (index date)
No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Investigational Site
Blue Bell, Pennsylvania, 19422
Investigational Site
Hinsdale, Illinois, 60521
Investigational Site
Kansas City, Missouri, 64111
Investigational Site
Los Angeles, California, 90025
Investigational Site
New York, New York, 10022
Investigational Site
San Antonio, Texas, 78229
Investigational Site
Valrico, Florida, 33596

Other trials in United States

About this study

Official title: Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing

Conditions: Allergic Asthma
Being tested: Xolair
Keywords: Asthma, Anaphylaxis
Medical subject headings: Asthma, Anaphylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XolairDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
Measured: Baseline (Enrollment Visit)
Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Measured: Baseline (Enrollment Visit)
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.
Measured: Baseline (Enrollment Visit)
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported.
Measured: Baseline (Enrollment Visit)
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Measured: Baseline (Enrollment Visit)
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.
Measured: Baseline (Enrollment Visit)
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
Measured: Baseline (Enrollment Visit)
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
Measured: Baseline (Enrollment Visit)
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Measured: Baseline (Enrollment Visit)
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
Measured: Baseline (Enrollment Visit)
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Measured: Baseline (Enrollment Visit)
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.
Measured: Baseline (Enrollment Visit)
Medications Within Two Weeks Prior to Blood Draw
Number of participants in each medication class is reported. Participants could have received more than 1 medication class.
Measured: Baseline (Enrollment Visit)
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.
Measured: Baseline (Enrollment Visit)
Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy
Measured: Substudy Day 1
Number of Participants With ATA - Skin Testing Substudy
Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.
Measured: Substudy Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Jan 2014

First posted23 Dec 2008 (estimated)
Study startMar 2009
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Allergic AsthmaStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00813748
Sponsor's protocol ID: Q4458g
Acronym: X-PAND
Status last verified: Jun 2017
First submitted: 22 Dec 2008
Last updated: 11 Jul 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma

All Allergic Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing
ClinicalTrials.gov ID: NCT00813748
Acronym / sponsor ID: X-PAND / Q4458g
Conditions: Allergic Asthma
Keywords: Asthma, Anaphylaxis
Study type: Observational
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2009 (actual)
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 23 Dec 2008 (estimated)
Results: Posted 15 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Other

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: primary care clinic

Key inclusion criteria (4 listed)

Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair
At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment
At least one dose of Xolair in the 18 months before the date of the case event (index date)
No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xolair	Drug	–

Primary outcome

Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants
Time frame: Baseline (Enrollment Visit)
Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.
Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Time frame: Baseline (Enrollment Visit)
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants
Time frame: Baseline (Enrollment Visit)
Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants
Time frame: Baseline (Enrollment Visit)
Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported.
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants
Time frame: Baseline (Enrollment Visit)
Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants
Time frame: Baseline (Enrollment Visit)
Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants
Time frame: Baseline (Enrollment Visit)
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants
Time frame: Baseline (Enrollment Visit)
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants
Time frame: Baseline (Enrollment Visit)
Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants
Time frame: Baseline (Enrollment Visit)
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants
Time frame: Baseline (Enrollment Visit)
Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants
Time frame: Baseline (Enrollment Visit)
Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.
Medications Within Two Weeks Prior to Blood Draw
Time frame: Baseline (Enrollment Visit)
Number of participants in each medication class is reported. Participants could have received more than 1 medication class.
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study
Time frame: Baseline (Enrollment Visit)
Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.
Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy
Time frame: Substudy Day 1
Number of Participants With ATA - Skin Testing Substudy
Time frame: Substudy Week 10
Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.

Results and safety

Results posted to the registry on 15 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omalizumab Cases	30	30
Omalizumab Controls	88	88

Primary outcome: Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants

Time frame: Baseline (Enrollment Visit). Number. Unit: participants

Measure	Omalizumab Cases n = 30
Cutaneous/Subcutaneous/Mucosal + R	24
Cutaneous/Subcutaneous/Mucosal + R + CV	2
Cutaneous/Subcutaneous/Mucosal + R + GIT	1
Cutaneous/Subcutaneous/Mucosal + CV	1
R + CV + GIT	1
CV	1

Population analysed: All enrolled participants.

Primary outcome: Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants

Time frame: Baseline (Enrollment Visit). Median (Full Range). Unit: minutes

Measure	Omalizumab Cases n = 27
Value	30 (0 to 210)

Population analysed: All enrolled participants. Here, number of participants analyzed signifies participants with available data for this outcome.

Primary outcome: Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants

Time frame: Baseline (Enrollment Visit). Number. Unit: participants

Measure	Omalizumab Cases n = 30
<30 minutes	13
30-60 minutes	8
>60-90 minutes	3
>90-120 minutes	2
>120-360 minutes	1
Missing	3

Population analysed: All enrolled participants.

Primary outcome: Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants

Time frame: Baseline (Enrollment Visit). Number. Unit: participants

Measure	Omalizumab Cases n = 30
1 Dose	6
2 Doses	3
3 Doses	2
4-20 Doses	8
21-40 Doses	4
41-60 Doses	4
>60 Doses	1
Missing	2

Population analysed: All enrolled participants.

Adverse events

Time frame: Main observational study: Baseline (enrollment visit); Skin test substudy: 10 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Study: Omalizumab Cases - With Anaphylaxis	0 of 30 (0%)	0 of 30 (0%)	Not reported
Observational Study: Omalizumab Controls - Without Anaphylaxis	0 of 88 (0%)	0 of 88 (0%)	Not reported
Skin Test Substudy: Omalizumab Cases - With Anaphylaxis	1 of 3 (33.3%)	1 of 3 (33.3%)	Not reported
Skin Test Substudy: Omalizumab Controls - Without Anaphylaxis	0 of 7 (0%)	1 of 7 (14.3%)	Not reported

Limitations and caveats (from the sponsor): Endpoint prioritization was not specified in study protocol; hence, all endpoints are reported as primary.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Allergic Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abdelkader Rahmaoui, M.D. study director

Genentech, Inc.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Allergic Asthma, run by Genentech, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants (time frame: Baseline (Enrollment Visit)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00813748.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.