Trial · NCT03629249
Systemic Corticosteroids Avoidance Study in Severe Asthma Patients
NCT03629249, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2021-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Systemic Corticosteroids Avoidance Study in Severe Asthma Patients. Trials, record NCT03629249. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03629249
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Systemic Corticosteroids Avoidance Study in Severe Asthma Patients
- NCT number
- NCT03629249
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 604 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Asthma
- Interventions
- Placebo once daily, QAW039 150 mg once daily, QAW039 450 mg once daily
- First posted
- 2018-08-14
- Last updated
- 2021-10-11
- Other registries' IDs
- eudract:2018-000212-25
- Results first posted
- 2021-02-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Overall Population | 52 weeks | All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF). Daily use of oral corticosteroids (number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject in the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form). The total systemic corticosteroids (SCS) dose data was aggregated into monthly data for analysis. For the patients discontinuing treatment early, the total SCS dose for 52 weeks was obtained as annualized SCS dose. For example if patient took 120 mg for 3 months then for 12 months patient will be taking 120\*12/3=480mg total SCS dose. The mean values over 52 weeks in the overall patient population regardless of peripheral blood eosinophil counts are reported here. |
| Primary | Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Subpopulation of Patients With High Eosinophil Count (≥ 250 Cells/µl) | 52 weeks | All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF). Daily use of oral corticosteroids (number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject in the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form). The total systemic corticosteroids (SCS) dose data was aggregated into monthly data for analysis. For the patients discontinuing treatment early, the total SCS dose for 52 weeks was obtained as annualized SCS dose. For example if patient took 120 mg for 3 months then for 12 months patient will be taking 120\*12/3=480mg total SCS dose. The mean values over 52 weeks in the subpopulation of patients with high peripheral blood eosinophil count at baseline are reported here. |
| Secondary | Change From Baseline in Daytime Symptom Scores | Baseline, up to Week 29-32 | All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening. The daytime asthma symptom score included 4 questions with a range of response categories for each question from 0 to 6 (0 = totally controlled; 6 = extremely poorly controlled). The questions were equally weighted and the overall score (from 0 to 6) was calculated as the average of the 4 questions with higher values indicating more asthma symptoms. Mean values of daytime asthma symptom scores were calculated over 4-week intervals during the treatment period. The baseline values of daytime asthma symptoms scores were defined as the average score during the run-in period. A negative change from baseline in daytime asthma symptom score is a favorable outcome. |
| Secondary | Change From Baseline in Nighttime Symptom Scores | Baseline, up to Week 29-32 | All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening. The nighttime asthma symptom score included 1 question with a range of response categories from 0 to 3 (0 = no awakening with asthma symptoms; 3 = awake all night). Mean values of nighttime asthma symptom scores were calculated over 4-week intervals during the treatment period. The baseline values of nighttime asthma symptoms scores were defined as the average score during the run-in period. A negative change from baseline in nighttime asthma symptom score is a favorable outcome. |
| Secondary | Change From Baseline in ACQ-5 Total Score up to End of Treatment Visit | Baseline, up to Week 28 | The Asthma Control Questionnaire (ACQ-5) was completed by the patients at the investigator's site. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions were equally weighted and the ACQ-5 score was the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). The baseline values of ACQ-5 score were defined as the ACQ-5 scores obtained on Day 1. A negative change from baseline in ACQ-5 score is a favorable outcome. |
| Secondary | Change From Baseline in AQLQ+12 Total Score up to End of Treatment Visit | Baseline, up to Week 28 | The Asthma Quality of Life Questionnaire (AQLQ+12) was completed by the patients at the investigator's site. The AQLQ+12 is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. Patients were asked to recall their experiences during the previous 2 weeks and to score each of the 32 items on a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. Each item of the AQLQ+12 was equally weighted and the overall score was the mean score of all 32 items and therefore ranged between 1 and 7. The baseline values of AQLQ+12 score were defined as the AQLQ+12 scores obtained on Day 1. A positive change from baseline in AQLQ+12 score is a favorable outcome. |
| Secondary | Percentage of Patients Requiring ≥ 7.5 mg Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Per Day Continuously for at Least 30 Days | Up to 36 weeks | All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF) to record medication use. Daily use of oral corticosteroids (the number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject using the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form). The percentage of patients requiring ≥ 7.5 mg systemic corticosteroid dose in mg prednisone/prednisolone (or equivalent) per day continuously for at least 30 days within the on-treatment period is presented in this record. |
| Secondary | Percentage of Patients With no Systemic Corticosteroids Use | Week 36 | All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF) to record medication use. Daily use of oral corticosteroids (the number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject using the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form). The percentage of patients with no systemic corticosteroids use up to visit on Week 36 is presented in this record. |
| Secondary | Percentage of Patients With Prescription of Biologic Therapy | Up to 36 weeks | As part of the flexible therapy, investigators were allowed to prescribe biologics approved for asthma from randomization visit onwards. Prescription of biologic therapy during the treatment period was recorded. The proportion of patients with prescription of biologic therapy during the on-treatment period is presented in this record. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Overall Population | 52 weeks | Full Analysis Set (FAS) | milligrams (mg) | MEAN |
| PRIMARY | Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Subpopulation of Patients With High Eosinophil Count (≥ 250 Cells/µl) | 52 weeks | Participants in the FAS with high peripheral blood eosinophil count count (≥ 250 cells/µl) at baseline | milligrams (mg) | MEAN |
| SECONDARY | Change From Baseline in Daytime Symptom Scores | Baseline, up to Week 29-32 | Participants in the FAS with a valid measurement for the outcome measure | score on scale | MEAN |
| SECONDARY | Change From Baseline in Nighttime Symptom Scores | Baseline, up to Week 29-32 | Participants in the FAS with a valid measurement for the outcome measure | score on scale | MEAN |
| SECONDARY | Change From Baseline in ACQ-5 Total Score up to End of Treatment Visit | Baseline, up to Week 28 | Participants in the FAS with a valid measurement for the outcome measure | score on scale | MEAN |
| SECONDARY | Change From Baseline in AQLQ+12 Total Score up to End of Treatment Visit | Baseline, up to Week 28 | Participants in the FAS with a valid measurement for the outcome measure | score on scale | MEAN |
| SECONDARY | Percentage of Patients Requiring ≥ 7.5 mg Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Per Day Continuously for at Least 30 Days | Up to 36 weeks | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With no Systemic Corticosteroids Use | Week 36 | FAS | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With Prescription of Biologic Therapy | Up to 36 weeks | FAS | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Overall Population | QAW039 150 mg | 219.67 | Full Range 0 to 9241.27 | milligrams (mg) | |
| Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Overall Population | QAW039 450 mg | 193.02 | Full Range 0 to 5184.19 | milligrams (mg) | |
| Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Overall Population | Placebo | 223.22 | Full Range 0 to 9552.69 | milligrams (mg) | |
| Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Subpopulation of Patients With High Eosinophil Count (≥ 250 Cells/µl) | QAW039 150 mg | 210.88 | Full Range 0 to 5352.80 | milligrams (mg) | |
| Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Subpopulation of Patients With High Eosinophil Count (≥ 250 Cells/µl) | QAW039 450 mg | 185.29 | Full Range 0 to 5184.19 | milligrams (mg) | |
| Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Subpopulation of Patients With High Eosinophil Count (≥ 250 Cells/µl) | Placebo | 212.66 | Full Range 0 to 9552.69 | milligrams (mg) | |
| Change From Baseline in Daytime Symptom Scores | QAW039 150 mg | Week 1-4 | -0.12 | Standard Deviation 0.494 | score on scale |
| Change From Baseline in Daytime Symptom Scores | QAW039 450 mg | Week 1-4 | -0.12 | Standard Deviation 0.497 | score on scale |
| Change From Baseline in Daytime Symptom Scores | Placebo | Week 1-4 | -0.09 | Standard Deviation 0.459 | score on scale |
| Change From Baseline in Daytime Symptom Scores | QAW039 150 mg | Week 5-8 | -0.21 | Standard Deviation 0.615 | score on scale |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QAW039 150 mg | 201 | |
| Overall Study | STARTED | QAW039 450 mg | 201 | |
| Overall Study | STARTED | Placebo | 202 | |
| Overall Study | Full Analysis Set (FAS) | QAW039 150 mg | 201 | |
| Overall Study | Full Analysis Set (FAS) | QAW039 450 mg | 200 | |
| Overall Study | Full Analysis Set (FAS) | Placebo | 201 | |
| Overall Study | Safety Set (SAF) | QAW039 150 mg | 201 | |
| Overall Study | Safety Set (SAF) | QAW039 450 mg | 200 | |
| Overall Study | Safety Set (SAF) | Placebo | 201 | |
| Overall Study | COMPLETED | QAW039 150 mg | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events45
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 | QAW039 150mg | 13 | 201 | |
| other | Nasopharyngitis | Infections and infestations | QAW039 450mg | 10 | 200 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 13 | 201 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | QAW039 150mg | 39 | 201 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | QAW039 450mg | 41 | 200 | |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 38 | 201 | |
| serious | Anaemia macrocytic | Blood and lymphatic system disorders | QAW039 150mg | 0 | 201 | |
| serious | Anaemia macrocytic | Blood and lymphatic system disorders | QAW039 450mg | 0 | 200 | |
| serious | Anaemia macrocytic | Blood and lymphatic system disorders | Placebo | 1 | 201 | |
| serious | Arteriosclerosis coronary artery | Cardiac disorders | QAW039 150mg | 0 | 201 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QAW039 150mg | 1 | 201 |
| Total, all-cause mortality | QAW039 450mg | 0 | 200 |
| Total, all-cause mortality | Placebo | 0 | 201 |
| Total, other adverse events | QAW039 150mg | 48 | 201 |
| Total, other adverse events | QAW039 450mg | 45 | 200 |
| Total, other adverse events | Placebo | 44 | 201 |
| Total, serious adverse events | QAW039 150mg | 7 | 201 |
| Total, serious adverse events | QAW039 450mg | 5 | 200 |
| Total, serious adverse events | Placebo | 4 | 201 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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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