Trial · NCT00527566
Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
NCT00527566, Phase 1, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2017-03-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome. Trials, record NCT00527566. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00527566
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
- NCT number
- NCT00527566
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Churg Strauss Syndrome
- Interventions
- Mepolizumab
- First posted
- 2007-09-11
- Last updated
- 2017-03-22
- Results first posted
- 2017-03-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Indicated Side Effects | Participants were followed for the duration of the study, approximately 44 weeks | Side effects experienced by participants 1 to 2 days after Mepolizumab infusion. |
| Primary | Number of Participants Who Experienced Specific Symptoms | 44 weeks | Number of participants who experienced specific symptoms during the trial. |
| Secondary | Steroid Dosing During Trial | 20 weeks | |
| Secondary | Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims | 20 weeks | The Asthma Control Questionnaire (ACQ) was one measure used to assess the prevalence of asthma symptoms the participant was having during the study. It is a series of 7 questions assessing how often, over the past two weeks, the participant wakes up from their asthma, how bad their symptoms were, etc. The greater the prevalence of symptoms, the higher the score. Each of the 7 questions is scored 0-6. The total score is calculated by adding the individual question scores and dividing the sum by 7. |
| Secondary | Efficacy- Exacerbation Rate | Treatment period (12 weeks) | Quantified the exacerbation rate (total number of exacerbations per day) of the participants during treatment with mepolizumab and without treatment. Exacerbations were characterized as any worsening of clinical disease requiring an increase of systemic corticosteroid therapy (e.g. prednisone) for asthma, respiratory symptoms, or underlying vasculitis. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Indicated Side Effects | Participants were followed for the duration of the study, approximately 44 weeks | Participants | NUMBER | |
| SECONDARY | Steroid Dosing During Trial | 20 weeks | Prednisone mg/day | MEAN | |
| SECONDARY | Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims | 20 weeks | units on a scale | MEAN | |
| PRIMARY | Number of Participants Who Experienced Specific Symptoms | 44 weeks | Participants | NUMBER | |
| SECONDARY | Efficacy- Exacerbation Rate | Treatment period (12 weeks) | Exacerbation rate (Exacerbations/day) | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Indicated Side Effects | Mepolizumab | Mild transient headaches | 3 | Participants | |
| Number of Participants With Indicated Side Effects | Mepolizumab | Mild pruritus | 1 | Participants | |
| Number of Participants With Indicated Side Effects | Mepolizumab | Urticaria, allergic reaction, worsening symptoms | 0 | Participants | |
| Number of Participants With Indicated Side Effects | Mepolizumab | Loose stool | 1 | Participants | |
| Steroid Dosing During Trial | Mepolizumab | Baseline (Week 0) | 14.3 | Full Range 10 to 20 | Prednisone mg/day |
| Steroid Dosing During Trial | Mepolizumab | Week 12 | 5.6 | Full Range 2 to 12.5 | Prednisone mg/day |
| Steroid Dosing During Trial | Mepolizumab | Week 20 | 4.9 | Full Range 0 to 20 | Prednisone mg/day |
| Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims | Mepolizumab | Week 0, baseline | 1.40 | Full Range 0 to 2.86 | units on a scale |
| Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims | Mepolizumab | Week 12, Treatment phase | 1.76 | Full Range 0.29 to 7 | units on a scale |
| Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims | Mepolizumab | Week 20, end of washout phase | 1.30 | Full Range 0 to 4.1 | units on a scale |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mepolizumab | 10 | |
| Overall Study | COMPLETED | Mepolizumab | 10 | |
| Overall Study | NOT COMPLETED | Mepolizumab | 0 |
Source ClinicalTrials.gov
Adverse events7
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 | Headache | Nervous system disorders | Mepolizumab | 4 | 10 | 5 |
| other | Digestive System Issues | Gastrointestinal disorders | Mepolizumab | 3 | 10 | 3 |
| other | Churg-Strauss Syndrome Flair | Endocrine disorders | Mepolizumab | 3 | 10 | 5 |
| other | Sinusitis | Respiratory, thoracic and mediastinal disorders | Mepolizumab | 3 | 10 | 4 |
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Mepolizumab | 7 | 10 | 8 |
| other | Wheezing and Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Mepolizumab | 7 | 10 | 8 |
| serious | Fractured Hip | Musculoskeletal and connective tissue disorders | Mepolizumab | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mepolizumab | ||
| Total, other adverse events | Mepolizumab | 9 | 10 |
| Total, serious adverse events | Mepolizumab | 1 | 10 |
Source ClinicalTrials.gov
Papers7
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.
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/NCT00527566
GET https://conductscience.org/api/trials/v1/NCT00527566/registered