Clinical Trial: Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome

Brief Summary: The purpose of this study is to determine whether Mepolizumab (a monoclonal antibody against interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in patients with steroid-dependent Churg-Strauss Syndrome (CSS).

Detailed Summary:

Specific Aims:

1. Document the safety of mepolizumab therapy in patients with CSS.
2. Demonstrate the steroid sparing effect of mepolizumab therapy by decreasing corticosteroid dosage while using this anti-IL5 therapy.

3. Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by:

   1. Measuring serum markers of CSS disease activity, including: peripheral eosinophilia, erythrocyte sedimentation rate, anti- neutrophil cytoplasmic antigen, C-reactive protein and IgE levels.
   2. Assessing the activity level of vasculitis via the Birmingham Vasculitis Activity Score
   3. Evaluating asthmatic response via serial peak flow and FEV1 measurements as well as asthma symptom scores using the Juniper scale.
   4. Assessing changes in novel parameters such as fractional excretion of nitric oxide and IL-5 levels.

Current Primary Outcome:

• Number of Participants With Indicated Side Effects [ Time Frame: Participants were followed for the duration of the study, approximately 44 weeks ]
  Side effects experienced by participants 1 to 2 days after Mepolizumab infusion.
• Number of Participants Who Experienced Specific Symptoms [ Time Frame: 44 weeks ]
  Number of participants who experienced specific symptoms during the trial.

Original Primary Outcome: Safety and tolerability of mepolizumab [ Time Frame: 44 weeks ]

Current Secondary Outcome:

• Steroid Dosing During Trial [ Time Frame: 20 weeks ]
• Evaluate Overall Positive Change in Churg-Strauss Syndrome Via the Measures Outlined in Study Aims [ Time Frame: 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.
• Efficacy- Exacerbation Rate [ Time Frame: 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.

Original Secondary Outcome:

• Demonstrate the steroid sparing effect of mepolizumab [ Time Frame: 44 weeks ]
• Evaluate overall improvement in CSS via the measures outlined in Study Aims [ Time Frame: 44 weeks ]

Dates:
Date Received: September 7, 2007
Date Started: September 2007
Date Completion:
Last Updated: February 1, 2017
Last Verified: February 2017