Last reviewed · How we verify

NCT01922037

A Study in Participants With Asthma Initiating Treatment With Omalizumab (Xolair)

Completed Phase 4 Results posted Last updated 11 December 2017
What this trial tests

Phase 4 trial testing Omalizumab in Asthma in 806 participants. Completed in 31 March 2016.

Timeline
19 June 2013
Primary endpoint
31 March 2016
31 March 2016

Quick facts

Lead sponsorHoffmann-La Roche
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment806
Start date19 June 2013
Primary completion31 March 2016
Estimated completion31 March 2016
Sites145 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

12 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Number of Asthma Exacerbations During Months 1-12 Primary · Months 1-12

An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/= 3 days.

GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.46± 0.815
Participants With Allergic Asthma (Age >/=18 Years)0.81± 1.407
Total Participants With Allergic Asthma0.78± 1.369
Total Number of Asthma Exacerbations During Months 1-6 Secondary · Months 1-6

An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/=3 days.

GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.20± 0.440
Participants With Allergic Asthma (Age >/=18 Years)0.51± 0.988
Total Participants With Allergic Asthma0.48± 0.957
Total Number of Asthma Exacerbations During Months 7-12 Secondary · Months 7-12

An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/= 3 days.

GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.29± 0.521
Participants With Allergic Asthma (Age >/=18 Years)0.35± 0.756
Total Participants With Allergic Asthma0.35± 0.738
Total Number of Asthma-Related Hospital Admissions During Months 1-12 Secondary · Months 1-12
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.04± 0.205
Participants With Allergic Asthma (Age >/=18 Years)0.06± 0.356
Total Participants With Allergic Asthma0.06± 0.346
Total Number of Asthma-Related Hospital Admissions During Months 1-6 Secondary · Months 1-6
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.03± 0.169
Participants With Allergic Asthma (Age >/=18 Years)0.03± 0.230
Total Participants With Allergic Asthma0.03± 0.225
Total Number of Asthma-Related Hospital Admissions During Months 7-12 Secondary · Months 7-12
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.02± 0.126
Participants With Allergic Asthma (Age >/=18 Years)0.03± 0.215
Total Participants With Allergic Asthma0.03± 0.208
Total Number of Asthma-Related ER Visits During Months 1-12 Secondary · Months 1-12
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.13± 0.380
Participants With Allergic Asthma (Age >/=18 Years)0.14± 0.575
Total Participants With Allergic Asthma0.14± 0.560
Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6 Secondary · Months 1-6
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.04± 0.205
Participants With Allergic Asthma (Age >/=18 Years)0.09± 0.410
Total Participants With Allergic Asthma0.09± 0.397
Total Number of Asthma-Related ER Visits During Months 7-12 Secondary · Months 7-12
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.10± 0.296
Participants With Allergic Asthma (Age >/=18 Years)0.06± 0.293
Total Participants With Allergic Asthma0.06± 0.294
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12 Secondary · Months 1-12
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.39± 0.771
Participants With Allergic Asthma (Age >/=18 Years)0.39± 0.866
Total Participants With Allergic Asthma0.39± 0.858
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6 Secondary · Months 1-6
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.23± 0.598
Participants With Allergic Asthma (Age >/=18 Years)0.23± 0.584
Total Participants With Allergic Asthma0.23± 0.585
Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12 Secondary · Months 7-12
GroupValue95% CI
Participants With Allergic Asthma (Age 12-17 Years)0.17± 0.423
Participants With Allergic Asthma (Age >/=18 Years)0.18± 0.515
Total Participants With Allergic Asthma0.18± 0.507

Adverse events — posted to ClinicalTrials.gov

Time frame: From signing of informed consent form to 28 days after participants last visit (up to approximately 1 year). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Allergic Asthma (Age 12-17 Years)
Serious: 5/69 (7%)
Deaths: —
Participants With Allergic Asthma (Age >/=18 Years)
Serious: 85/732 (12%)
Deaths: —
Total Participants With Allergic Asthma
Serious: 90/801 (11%)
Deaths: —

Serious adverse events (71 terms)

ReactionSystemParticipants With Allergic…Participants With Allergic…Total Participants With Al…
AsthmaRespiratory, thoracic and mediastinal disorders———
PneumoniaInfections and infestations———
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders———
Pulmonary embolismRespiratory, thoracic and mediastinal disorders———
Status asthmaticusRespiratory, thoracic and mediastinal disorders———
Acute left ventricular failureCardiac disorders———
Myocardial infarctionCardiac disorders———
Abdominal painGastrointestinal disorders———
Chest painGeneral disorders———
CholelithiasisHepatobiliary disorders———
Anaphylactic reactionImmune system disorders———
CellulitisInfections and infestations———
DiverticulitisInfections and infestations———
InfluenzaInfections and infestations———
DehydrationMetabolism and nutrition disorders———
Abortion spontaneousPregnancy, puerperium and perinatal conditions———
NephrolithiasisRenal and urinary disorders———
DyspnoeaRespiratory, thoracic and mediastinal disorders———
Angina pectorisCardiac disorders———
ArrhythmiaCardiac disorders———
Atrial fibrillationCardiac disorders———
Cardiac arrestCardiac disorders———
Cardiogenic shockCardiac disorders———
Coronary artery thrombosisCardiac disorders———
Ventricular fibrillationCardiac disorders———
Other adverse events (61 terms — click to expand)

ReactionSystemParticipants With Allergic…Participants With Allergic…Total Participants With Al…
AsthmaRespiratory, thoracic and mediastinal disorders———
UrticariaSkin and subcutaneous tissue disorders———
Anaphylactic reactionImmune system disorders———
Chest discomfortGeneral disorders———
Injection site reactionGeneral disorders———
BronchitisInfections and infestations———
PneumoniaInfections and infestations———
WheezingRespiratory, thoracic and mediastinal disorders———
PruritusSkin and subcutaneous tissue disorders———
HypothyroidismEndocrine disorders———
DiarrhoeaGastrointestinal disorders———
Paraesthesia oralGastrointestinal disorders———
VomitingGastrointestinal disorders———
FatigueGeneral disorders———
Influenza like illnessGeneral disorders———
Injection site painGeneral disorders———
Injection site pruritusGeneral disorders———
Injection site swellingGeneral disorders———
Local reactionGeneral disorders———
PainGeneral disorders———
CholecystitisHepatobiliary disorders———
Serum sicknessImmune system disorders———
Acute sinusitisInfections and infestations———
InfluenzaInfections and infestations———
Mononucleosis syndromeInfections and infestations———
Pneumonia mycoplasmalInfections and infestations———
Upper respiratory tract infectionInfections and infestations———
Urinary tract infectionInfections and infestations———
FallInjury, poisoning and procedural complications———
LacerationInjury, poisoning and procedural complications———
Pelvic fractureInjury, poisoning and procedural complications———
HyperlipidaemiaMetabolism and nutrition disorders———
HypertriglyceridaemiaMetabolism and nutrition disorders———
Type 2 diabetes mellitusMetabolism and nutrition disorders———
ArthralgiaMusculoskeletal and connective tissue disorders———
Bone painMusculoskeletal and connective tissue disorders———
Muscle spasmsMusculoskeletal and connective tissue disorders———
Muscular weaknessMusculoskeletal and connective tissue disorders———
MyalgiaMusculoskeletal and connective tissue disorders———
Thyroid cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)———

Most-reported serious reactions: Asthma, Pneumonia, Chronic obstructive pulmonary disease, Pulmonary embolism, Status asthmaticus, Acute left ventricular failure, Myocardial infarction, Abdominal pain.

Data from ClinicalTrials.gov NCT01922037 adverse events section.

Sponsor's own description

This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Eosinophilic Asthma: Pathophysiology and Therapeutic Horizons.
    Hussain M, Liu G. · · 2024 · cited 60× · PMID 38474348 · DOI 10.3390/cells13050384
  2. Severe Asthma and Biological Therapy: When, Which, and for Whom.
    Rogliani P, Calzetta L, Matera MG, Laitano R, et al · · 2020 · cited 56× · PMID 32048241 · DOI 10.1007/s41030-019-00109-1
  3. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma.
    Chen M, Shepard K, Yang M, Raut P, et al · · 2021 · cited 47× · PMID 33217063 · DOI 10.1111/cea.13790
  4. Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO.
    Chipps BE, Zeiger RS, Luskin AT, Busse WW, et al · · 2017 · cited 22× · PMID 29054589 · DOI 10.1016/j.anai.2017.09.056
  5. Omalizumab response in patients with asthma by number and type of allergen.
    Soong W, Yoo B, Pazwash H, Holweg CTJ, et al · · 2021 · cited 15× · PMID 33838339 · DOI 10.1016/j.anai.2021.04.002
  6. No difference in omalizumab efficacy in patients with asthma by number of asthma-related and allergic comorbidities.
    Chen M, Choo E, Yoo B, Raut P, et al · · 2021 · cited 10× · PMID 33465457 · DOI 10.1016/j.anai.2021.01.015
  7. Packaging and Delivery of Asthma Therapeutics.
    Mathis BJ, Kusumoto M, Zaboronok A, Hiramatsu Y. · · 2021 · cited 9× · PMID 35056988 · DOI 10.3390/pharmaceutics14010092
  8. Does Comorbid Food Allergy Affect Response to Omalizumab in Patients with Asthma?
    Fiocchi A, Chinthrajah RS, Ansotegui IJ, Sriaroon P, et al · · 2024 · cited 2× · PMID 39309477 · DOI 10.2147/jaa.s475517

Verify or expand the search:

Other trials of Omalizumab

Trials testing the same drug.

Other recruiting trials for Asthma

Currently open trials in the same condition.

Other Hoffmann-La Roche trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01922037.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing