Trial · NCT01430403
Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
NCT01430403, Phase 4, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2015-09-16
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ConductScience Library. Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations. Trials, record NCT01430403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01430403
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
- NCT number
- NCT01430403
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 478 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Asthma
- Interventions
- Omalizumab, Inhaled Corticosteroid Boost Therapy (ICS), Placebo omalizumab, Placebo fluticasone
- First posted
- 2011-09-08
- Last updated
- 2017-05-30
- Results first posted
- 2015-09-16
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) | 90 Day outcome period | Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. Odds ratio comparing Placebo and Omalizumab arms across all treatment steps (Steps 2-5). |
| Primary | Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4) | 90 Day outcome period | Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. Odds ratio comparing Inhaled corticosteroid boost therapy (ICS) and Omalizumab arms at Treatment Steps 2-4. |
| Secondary | Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples | 90 Day outcome period | Asthma exacerbation:defined by a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the 1st day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥ 10mg per day for ≥1 day. Exacerbations were then associated with viral respiratory infections based on nasal mucus samples collected monthly. Nasal mucus samples were categorized as having exacerbations or not having exacerbations. Participants could potentially be counted in each group, as participants could have samples with exacerbations and samples without exacerbations. |
| Secondary | Severity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo | 90 Day outcome period | Severity asthma symptoms is defined as the highest value among the following 3 variables: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep as a result of asthma; and number of days on which a participant had to slow down or discontinue play/physical activities over a two week period associated with a viral infection. This outcome looks at the effect by group on number of days with asthma symptoms and infections. The hypothesis behind this outcome measure is that omalizumab will change virology; thus, the the intent of this measure was to assess the comparator group of placebo against omalizumab |
| Secondary | Number of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo | 90 Day outcome period | Asthma exacerbation is defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. The hypothesis behind this outcome measure is that omalizumab will change virology; thus, the intent of this measure was to assess the comparator group of placebo against omalizumab. |
| Secondary | Composite Asthma Severity Index (CASI), Treatment Steps 2-5: Omalizumab vs. Placebo | 90 Day outcome period | CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma. |
| Secondary | Composite Asthma Severity Index (CASI), Treatment Steps 2-4: Omalizumab vs. ICS | 90 Day outcome period | CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma. |
| Secondary | Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted, Treatment Steps 2-5:Omalizumab vs. Placebo | 90 Day outcome period | FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 \<80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race. |
| Secondary | Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted , Treatment Steps 2-4: Omalizumab vs. ICS | 90 Day outcome period | FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 \<80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race. |
| Secondary | Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-5: Omalizumab vs. Placebo | 90 Day outcome period | The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 - 19 years of age=85%. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) | 90 Day outcome period | Intent-to-treat | Percent of adjusted prevalence | NUMBER |
| PRIMARY | Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4) | 90 Day outcome period | Intent-to-treat | Percent of adjusted prevalence | NUMBER |
| SECONDARY | Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples | 90 Day outcome period | Nasal mucus samples | Percent Samples with virus | NUMBER |
| SECONDARY | Severity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo | 90 Day outcome period | The pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data). | Maximum Symptoms Days | MEAN |
| SECONDARY | Number of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo | 90 Day outcome period | The pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data). | Total Number of Viral Infections | MEAN |
| SECONDARY | Composite Asthma Severity Index (CASI), Treatment Steps 2-5: Omalizumab vs. Placebo | 90 Day outcome period | Intent-to-treat | CASI Score | MEAN |
| SECONDARY | Composite Asthma Severity Index (CASI), Treatment Steps 2-4: Omalizumab vs. ICS | 90 Day outcome period | Intent-to-treat with available CASI scores | CASI Score | MEAN |
| SECONDARY | Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted, Treatment Steps 2-5:Omalizumab vs. Placebo | 90 Day outcome period | Intent-to-treat | percent predicted FEV1 | MEAN |
| SECONDARY | Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted , Treatment Steps 2-4: Omalizumab vs. ICS | 90 Day outcome period | Intent-to-treat | percent predicted FEV1 | MEAN |
| SECONDARY | Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-5: Omalizumab vs. Placebo | 90 Day outcome period | Intent-to-treat | percent FEV1/FVC ratio | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) | Treatment Steps 2-5: Omalizumab | 11.3 | Percent of adjusted prevalence | ||
| Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) | Treatment Steps 2-5: Placebo | 21.0 | Percent of adjusted prevalence | ||
| Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4) | Treatment Steps 2-4: Omalizumab | 8.4 | Percent of adjusted prevalence | ||
| Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4) | Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS) | 11.1 | Percent of adjusted prevalence | ||
| Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples | Samples With Exacerbations | 71.8 | Percent Samples with virus | ||
| Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples | Samples Without Exacerbations | 40.4 | Percent Samples with virus | ||
| Severity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo | Omalizumab | 1.2 | Standard Error 0.09 | Maximum Symptoms Days | |
| Severity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo | Placebo | 1.8 | Standard Error 0.23 | Maximum Symptoms Days | |
| Number of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo | Omalizumab | 5.6 | Standard Error 0.19 | Total Number of Viral Infections | |
| Number of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo | Placebo | 5.8 | Standard Error 0.13 | Total Number of Viral Infections |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omalizumab | 259 | |
| Overall Study | STARTED | Inhaled Corticosteroid Boost Therapy (ICS) | 130 | |
| Overall Study | STARTED | Placebo | 89 | |
| Overall Study | COMPLETED | Omalizumab | 242 | |
| Overall Study | COMPLETED | Inhaled Corticosteroid Boost Therapy (ICS) | 121 | |
| Overall Study | COMPLETED | Placebo | 81 | |
| Overall Study | NOT COMPLETED | Omalizumab | 17 | |
| Overall Study | NOT COMPLETED | Inhaled Corticosteroid Boost Therapy (ICS) | 9 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Omalizumab | 10 | 259 | 13 |
| other | Nasopharyngitis | Infections and infestations | Inhaled Corticosteroid Boost Therapy (ICS) | 8 | 130 | 9 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 3 | 89 | 3 |
| other | Headache | Nervous system disorders | Omalizumab | 17 | 259 | 18 |
| other | Headache | Nervous system disorders | Inhaled Corticosteroid Boost Therapy (ICS) | 4 | 130 | 5 |
| other | Headache | Nervous system disorders | Placebo | 6 | 89 | 7 |
| other | Rash | Skin and subcutaneous tissue disorders | Omalizumab | 16 | 259 | 16 |
| other | Rash | Skin and subcutaneous tissue disorders | Inhaled Corticosteroid Boost Therapy (ICS) | 5 | 130 | 5 |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 4 | 89 | 4 |
| serious | Anaphylactic reaction | Immune system disorders | Omalizumab | 0 | 259 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omalizumab | 0 | 259 |
| Total, all-cause mortality | Inhaled Corticosteroid Boost Therapy (ICS) | 0 | 130 |
| Total, all-cause mortality | Placebo | 0 | 89 |
| Total, other adverse events | Omalizumab | 41 | 259 |
| Total, other adverse events | Inhaled Corticosteroid Boost Therapy (ICS) | 16 | 130 |
| Total, other adverse events | Placebo | 12 | 89 |
| Total, serious adverse events | Omalizumab | 0 | 259 |
| Total, serious adverse events | Inhaled Corticosteroid Boost Therapy (ICS) | 1 | 130 |
| Total, serious adverse events | Placebo | 1 | 89 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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