An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)

Browse trials for

• Aspergillosis 201
• Pulmonary Aspergillosis 78
• Aspergillosis, Allergic Bronchopulmonary 45
• Cystic Fibrosis 1,581
• Fibrosis 3,255

Keywords

• Cystic Fibrosis
• Allergic Bronchopulmonary Aspergillosis
• omalizumab
• oral corticosteroid use
• anti-immunoglobulin E

Aspergillosis

201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.

This study's enrollment of 14 is below the median of 50 across 106 interventional studies indexed under Aspergillosis.

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Study arms

• Experimental
  Omalizumab

  Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg. Participants who completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.

  Drug: Omalizumab · Drug: Itraconazole

• Placebo comparator
  Placebo

  Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.

  Drug: Placebo · Drug: Itraconazole

Interventions

• DrugOmalizumab

  Omalizumab subcutaneous injections of 600 mg daily.

  Also known as: Xolair, IGE025

• DrugPlacebo

  Placebo subcutaneous injections blinded to match experimental arm dosing regimen.

• DrugItraconazole

  Itraconazole twice daily with a maximum daily dose of 400 mg.

  Also known as: Sporanox

Primary outcomes

1. Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen

   Time frame: 6 months of blinded treatment

Secondary outcomes

1. Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period

   Time frame: 6 months, 12 months

2. Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment

   Time frame: 3 months, 6 months

3. Time to Steroid Free State.

   Time frame: 12 months

4. Change From Baseline in Average Oral Corticosteroid Use.

   Time frame: 6 months, 12 months

5. Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline

   Time frame: 6 months, 12 months

Baseline characteristics

Publications

• Beam KT, Coop CA. Steroid sparing effect of omalizumab in seropositive allergic bronchopulmonary aspergillosis. Allergy Rhinol (Providence). 2015 Jan;6(2):143-5. doi: 10.2500/ar.2015.6.0128. PubMed 26302738 ↗