Trial · NCT01202903
Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
NCT01202903, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2015-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy. Trials, record NCT01202903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01202903
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
- NCT number
- NCT01202903
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 616 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Persistent Allergic Asthma
- Interventions
- Omalizumab, Placebo
- First posted
- 2010-09-16
- Last updated
- 2015-03-23
- Results first posted
- 2015-03-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period | Baseline, 24 weeks | A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates. |
| Secondary | Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment | Baseline, 24 weeks | A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates. |
| Secondary | Change From Baseline in % Predicted FEV1 Following 24-week Treatment | Baseline, 24 weeks | Spirometry was used at defined time points throughout the study to assess the clinical status of patients and to capture the following variables: forced expiratory volume in one second (FEV1), FEV1 percent predicted, forced vital capacity (FVC) and the FEV1/FVC ratio. During the Screening assessment, spirometry was performed pre- and post-bronchodilator administration to assess reversibility. During the treatment period (including prerandomization assessments on Day 1), spirometry was performed after withholding bronchodilators. The results of spirometry were required to meet the ATS/ERS criteria for acceptability and repeatability. Acceptability criteria were applied before repeatability was determined. LS Mean of change from baseline in % predicted FEV1 is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline % predicted FEV1 as covariates. |
| Secondary | Change From Baseline in AQLQ Score Following 24-week Treatment | 24 weeks | The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients' asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement. |
| Secondary | Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment | 24 weeks | The standardized version of the Asthma Quality of Life Questionnaire (AQLQs)), was used to assess the patients' asthma-related quality of life. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental exposure). Each question was answered on a 7 point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). The overall AQLQ score is the mean of all 32 responses, and the individual domain scores are the means of the items in those domains (a minimum domain / overall score of 1 = Severely impaired whereas a maximum domain / overall score of 7 = not impaired at all). A positive change from baseline score indicates improvement. |
| Secondary | Change From Baseline in ACQ Score Following 24-week Treatment | 24 weeks | The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator's site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. LS Mean of change from baseline in ACQ score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, center grouping, smoking status, and baseline ACQ score as covariates. Score 0= totally controlled, 6= extremely poorly controlled |
| Secondary | Percentage of Patients With at Least a 0.5 or 0.75 Point Improvement in the ACQ Score at Week 24 | 24 weeks | The Asthma Control Questionnaire (ACQ) is a questionnaire consisting of 7 questions assessing symptoms, airway caliber and rescue β2-agonist use. One value representing overall asthma control on that occasion was calculated. Decrease in scores of 0.5 or higher between ACQ assessments are considered clinically meaningful. The ACQ was completed by the patient at the Investigator's site at Visit 2 (Week 1, pre-dose), Visit 6 (after completion of 16 weeks of treatment) and at the End of Study/Early Termination visit. Only patients with no more than 1 item missing are included, and the missing item was imputed by interpolation |
| Secondary | Change From Baseline in Asthma Symptom Scores Following 24-week Treatment | 24 weeks | Total asthma symptom score was derived for each day as the total of the morning (scale 0-1), daytime (scale 0-4) and nocturnal (scale 0-4) scores with a max score of 9. The mean score across the 28 days prior to the week 24 assessment visit was used to calculate a change from baseline. Analysis of total asthma symptom score was performed using ANCOVA model and Van-Elteren test. LS Mean of change from baseline in mean asthma symptom score is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean asthma symptom scores as covariates. Decrease of score on change from baseline means improvement of asthma symptom control. |
| Secondary | Percentage of Participants With Investigator and Patient Global Evaluation of Treatment Effectiveness (GETE) at Weeks 16 and 24 | 16 and 24 weeks | The global evaluation of treatment effectiveness (GETE) is an assessment of asthma symptom control and overall response to asthma treatment. The evaluation was performed by both investigator and patient, each using the same 5 point scale. The GETE scale ranges were as follows: excellent, good, moderate, poor and worsening. A good or excellent response on the 5 point scale indicated that a patient had responded to treatment. 1=excellent 2=good 3=moderate 4=poor 5= worsening. Responder is defined as the patient who achieved an excellent or good response. Non-responder isdefined as the patient who achieved a moderate or poor or worsening response. |
| Secondary | Change From Baseline in Number of Puffs of Asthma Rescue Medication Following 24-week Treatment | 24 weeks | Analysis of rescue medication use followed a similar method to that employed for total asthma symptom score. The mean number of puffs across the 28 days prior to the Week 24 assessment visit was used to calculate a change from baseline. LS Mean of change from baseline in mean number of puffs of asthma rescue medication is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, smoking status, center grouping, and baseline mean number of puffs of asthma rescue medication as covariates. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period | Baseline, 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | L/min | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment | Baseline, 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | L/min | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in % Predicted FEV1 Following 24-week Treatment | Baseline, 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | L/min | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in AQLQ Score Following 24-week Treatment | 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment | 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | Percent | NUMBER |
| SECONDARY | Change From Baseline in ACQ Score Following 24-week Treatment | 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With at Least a 0.5 or 0.75 Point Improvement in the ACQ Score at Week 24 | 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | Percent | NUMBER |
| SECONDARY | Change From Baseline in Asthma Symptom Scores Following 24-week Treatment | 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Investigator and Patient Global Evaluation of Treatment Effectiveness (GETE) at Weeks 16 and 24 | 16 and 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | Percent | NUMBER |
| SECONDARY | Change From Baseline in Number of Puffs of Asthma Rescue Medication Following 24-week Treatment | 24 weeks | The FAS consisted of all randomized patients who received at least one dose of study drug. 7 randomized patients did not receive study drug and were excluded along with 1 other patient who did not receive study drug for more than 60 days | Number of puffs | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period | Omalizumab | 27.03 | Standard Error 20.865 | L/min | |
| Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period | Placebo | 18.18 | Standard Error 21.086 | L/min | |
| Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment | Omalizumab | 22.96 | Standard Error 20.145 | L/min | |
| Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment | Placebo | 15.53 | Standard Error 20.350 | L/min | |
| Change From Baseline in % Predicted FEV1 Following 24-week Treatment | Omalizumab | 19.113 | Standard Error 5.6130 | L/min | |
| Change From Baseline in % Predicted FEV1 Following 24-week Treatment | Placebo | 14.989 | Standard Error 5.6645 | L/min | |
| Change From Baseline in AQLQ Score Following 24-week Treatment | Omalizumab | Overall Score (n=182,178) | 0.51 | Standard Error 0.155 | Units on a scale |
| Change From Baseline in AQLQ Score Following 24-week Treatment | Placebo | Overall Score (n=182,178) | 0.10 | Standard Error 0.155 | Units on a scale |
| Change From Baseline in AQLQ Score Following 24-week Treatment | Omalizumab | Symptom Score (n=208,206) | 0.47 | Standard Error 0.143 | Units on a scale |
| Change From Baseline in AQLQ Score Following 24-week Treatment | Placebo | Symptom Score (n=208,206) | 0.18 | Standard Error 0.142 | Units on a scale |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Omalizumab | 308 | |
| Overall Study | STARTED | Placebo | 308 | |
| Overall Study | Full Analysis Set | Omalizumab | 306 | |
| Overall Study | Full Analysis Set | Placebo | 302 | |
| Overall Study | Safety Set* | Omalizumab | 310 | |
| Overall Study | Safety Set* | Placebo | 299 | |
| Overall Study | COMPLETED | Omalizumab | 297 | |
| Overall Study | COMPLETED | Placebo | 292 | |
| Overall Study | NOT COMPLETED | Omalizumab | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events44
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 | Pyrexia | General disorders | Omalizumab | 4 | 310 | |
| other | Pyrexia | General disorders | Placebo | 2 | 299 | |
| other | Influenza | Infections and infestations | Omalizumab | 3 | 310 | |
| other | Influenza | Infections and infestations | Placebo | 5 | 299 | |
| other | Nasopharyngitis | Infections and infestations | Omalizumab | 20 | 310 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 26 | 299 | |
| other | Upper respiratory tract infection | Infections and infestations | Omalizumab | 40 | 310 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 38 | 299 | |
| other | Dizziness | Nervous system disorders | Omalizumab | 5 | 310 | |
| other | Dizziness | Nervous system disorders | Placebo | 2 | 299 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 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 | 95 | 310 |
| Total, other adverse events | Placebo | 90 | 299 |
| Total, serious adverse events | Omalizumab | 8 | 310 |
| Total, serious adverse events | Placebo | 11 | 299 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34611470 | DERIVED |
Source PubMed
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/NCT01202903
GET https://conductscience.org/api/trials/v1/NCT01202903/results?page=2