The Prednisone-sparing Effect of Anti-IL-5 Antibody (SB-240563)

NCT00292877 | Completed Phase 2

• 3 other identifiers: RP#02-2115SB-240563/0469427-F2453-21C
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if treatment with anti-IL-5 antibody has a prednisone-sparing effect in patients with symptomatic eosinophilic bronchitis (with or without asthma).

Conditions

Asthma

Keywords

1. Eosinophilic bronchitis, 2. Asthma, 3. Steroid dependent asthma, 4. Sputum eosinophils, 5. SB-240563 (Mepolizumab)

Outcome Measures

Primary Outcomes (2)

• The prednisone-sparing effect of SB-240563 versus placebo as

• indicated by the absolute and percentage dose reduction possible without a clinical exacerbation (as measured by the Juniper ACQ in patients with asthma or by Likert symptom scores +/- FEV1 in patients with eosinophilic bronchitis without asthma).

Secondary Outcomes (4)

• The prednisone-sparing effect of SB-240563 or placebo as indicated

• by the absolute and percentage dose reduction possible without a clinical

• exacerbation as measured by

• a.% sputum eosinophils, b. FEV1 % predicted and methacholine PC20., c. Blood eosinophils, d. Amount of rescue salbutamol use., e. Time to exacerbation.

Interventions

SB-240563 (Mepolizumab) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, aged 18-70 years, who have been followed as an outpatient and who have been found to require a minimum dose of prednisone treatment (in addition to high-dose inhaled steroid treatment) to prevent frequent exacerbations associated with induced sputum eosinophilia.
• Patients will be enrolled if, at screening and baseline visits, they demonstrate sputum eosinophilia and symptoms. The symptoms may effect activity and sleep but should not, in the opinion of the treating physician, be severe enough to be of concern.
• While FEV1 after withholding bronchodilators appropriately, before and after inhaled salbutamol (200 mg), and methacholine PC20 will be measured, these need not be abnormal since the prednisone is required for the control of eosinophilic bronchitis and any clinical consequences of this, and because the bronchitis can occur without these features of asthma.
• On the same doses of corticosteroids for a least one-month.

You may not qualify if:

• Pregnancy, breast-feeding or lack of effective contraception in females of childbearing potential or females who are postmenopausal \<1 year.
• Exposure to a relevant seasonal environmental allergen, known to worsen asthma control, during the study period.
• Respiratory tract infection in the 4-weeks before the baseline visit.
• Clinical exacerbation requiring extra prednisone treatment in the 4-weeks before V1.
• Other cardiac, pulmonary, renal or systemic diseases that in the investigator's opinion may interfere with the study results or compromise subject's safety.
• Previous participation in any study using anti-monoclonal drug.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Firestone Institute for Respiratory Health, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (6)

• Sanderson CJ. The biological role of interleukin 5. Int J Cell Cloning. 1990 Jan;8 Suppl 1:147-53; discussion 153-4. doi: 10.1002/stem.5530080713.

  PMID: 2182734 BACKGROUND

• Leckie MJ, ten Brinke A, Khan J, Diamant Z, O'Connor BJ, Walls CM, Mathur AK, Cowley HC, Chung KF, Djukanovic R, Hansel TT, Holgate ST, Sterk PJ, Barnes PJ. Effects of an interleukin-5 blocking monoclonal antibody on eosinophils, airway hyper-responsiveness, and the late asthmatic response. Lancet. 2000 Dec 23-30;356(9248):2144-8. doi: 10.1016/s0140-6736(00)03496-6.

  PMID: 11191542 BACKGROUND

• Djukanovic R, Roche WR, Wilson JW, Beasley CR, Twentyman OP, Howarth RH, Holgate ST. Mucosal inflammation in asthma. Am Rev Respir Dis. 1990 Aug;142(2):434-57. doi: 10.1164/ajrccm/142.2.434.

  PMID: 2200318 BACKGROUND

• Djukanovic R, Sterk PJ, Fahy JV, Hargreave FE. Standardised methodology of sputum induction and processing. Eur Respir J Suppl. 2002 Sep;37:1s-2s. doi: 10.1183/09031936.02.00000102. No abstract available.

  PMID: 12361359 BACKGROUND

• Pavord ID, Brightling CE, Woltmann G, Wardlaw AJ. Non-eosinophilic corticosteroid unresponsive asthma. Lancet. 1999 Jun 26;353(9171):2213-4. doi: 10.1016/S0140-6736(99)01813-9. No abstract available.

  PMID: 10392993 BACKGROUND

• Nair P, Pizzichini MM, Kjarsgaard M, Inman MD, Efthimiadis A, Pizzichini E, Hargreave FE, O'Byrne PM. Mepolizumab for prednisone-dependent asthma with sputum eosinophilia. N Engl J Med. 2009 Mar 5;360(10):985-93. doi: 10.1056/NEJMoa0805435.

  PMID: 19264687 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

mepolizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Frederick E Hargreave, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 16, 2006
• Study Start: January 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 24, 2011

Record last verified: 2011-01

Locations

CA (1)