Trial · NCT00079937
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
NCT00079937, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-08-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma. Trials, record NCT00079937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00079937
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
- NCT number
- NCT00079937
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 628 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Asthma
- Interventions
- Omalizumab, Placebo, Fluticasone
- First posted
- 2004-03-22
- Last updated
- 2012-04-11
- Results first posted
- 2011-08-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period | Baseline to end of the fixed-dose steroid treatment period (Week 24) | A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period. |
| Primary | Percentage of Participants With at Least 1 Adverse Event | Baseline to end of the study (Week 68) | See Adverse Events module for details. |
| Secondary | Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period | Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question "How did you sleep last night?", with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement. |
| Secondary | Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period | Baseline to end of the treatment period (Week 52) | A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period. |
| Secondary | Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period | Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication. |
| Secondary | Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24) | Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24) | PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Units on a scale | MEAN |
| PRIMARY | Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period | Baseline to end of the fixed-dose steroid treatment period (Week 24) | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Exacerbations per patient per 24-weeks | MEAN |
| SECONDARY | Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period | Baseline to end of the treatment period (Week 52) | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Exacerbations per patient per year | MEAN |
| SECONDARY | Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Puffs | MEAN |
| SECONDARY | Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24) | Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24) | Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants With at Least 1 Adverse Event | Baseline to end of the study (Week 68) | Safety population: All patients who received any study drug and had at least 1 post-baseline safety assessment. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Omalizumab | -0.63 | Standard Deviation 0.72 | Units on a scale | |
| Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Placebo | -0.50 | Standard Deviation 0.71 | Units on a scale | |
| Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period | Omalizumab | 0.45 | 95% Confidence Interval 0.36 to 0.55 | Exacerbations per patient per 24-weeks | |
| Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period | Placebo | 0.64 | 95% Confidence Interval 0.49 to 0.83 | Exacerbations per patient per 24-weeks | |
| Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period | Omalizumab | 0.78 | 95% Confidence Interval 0.65 to 0.94 | Exacerbations per patient per year | |
| Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period | Placebo | 1.36 | 95% Confidence Interval 0.92 to 1.71 | Exacerbations per patient per year | |
| Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Omalizumab | -1.3 | Standard Deviation 2.84 | Puffs | |
| Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period | Placebo | -1.0 | Standard Deviation 2.50 | Puffs | |
| Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24) | Omalizumab | Activity limitation | 0.85 | 95% Confidence Interval 0.72 to 0.99 | Units on a scale |
| Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24) | Placebo | Activity limitation | 0.76 | 95% Confidence Interval 0.59 to 0.93 | Units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omalizumab | 421 | |
| Overall Study | STARTED | Placebo | 207 | |
| Overall Study | COMPLETED | Omalizumab | 352 | |
| Overall Study | COMPLETED | Placebo | 175 | |
| Overall Study | NOT COMPLETED | Omalizumab | 69 | |
| Overall Study | NOT COMPLETED | Placebo | 32 |
Source ClinicalTrials.gov
Adverse events104
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 | Abdominal pain | Gastrointestinal disorders | Omalizumab | 23 | 421 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 12 | 207 | |
| other | Diarrhoea | Gastrointestinal disorders | Omalizumab | 20 | 421 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 12 | 207 | |
| other | Vomiting | Gastrointestinal disorders | Omalizumab | 34 | 421 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 24 | 207 | |
| other | Pyrexia | General disorders | Omalizumab | 59 | 421 | |
| other | Pyrexia | General disorders | Placebo | 20 | 207 | |
| other | Bronchitis | Infections and infestations | Omalizumab | 36 | 421 | |
| other | Bronchitis | Infections and infestations | Placebo | 29 | 207 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omalizumab | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Omalizumab | 374 | 421 |
| Total, other adverse events | Placebo | 194 | 207 |
| Total, serious adverse events | Omalizumab | 27 | 421 |
| Total, serious adverse events | Placebo | 26 | 207 |
Source ClinicalTrials.gov
Papers5
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Omalizumab vs Placebo: serious adverse events |
Source Trial comparisons
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00079937
GET https://conductscience.org/api/trials/v1/NCT00079937/events?page=2