NCT00117611

Brief Summary

The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair (omalizumab), will improve objective and subjective evidence of chronic sinusitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

1.8 years

First QC Date

June 30, 2005

Last Update Submit

September 27, 2013

Conditions

Sinusitis

Keywords

chronic sinusitis

Outcome Measures

Primary Outcomes (1)

  • Mucosal thickness on CT scan

    after 6 months of treatment

Secondary Outcomes (9)

  • Rhinosinusitis Disability Index (RSDI)recorded monthly

    6 months

  • A specific quality of life (QOL) measure, Sino-Nasal Outcome Test (SNOT 20)recorded monthly

    6 months

  • A general health QOL measure (SF-36)

    6 months

  • The number of sinusitis exacerbations requiring additional treatment

    6 months

  • Nasal peak inspiratory flow

    6 months

  • +4 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Xolair administered subcutaneously, once or twice monthly (dose dependent on subject weight and serum IgE level)

Drug: Anti-IgE antibody omalizumab or placebo

2

PLACEBO COMPARATOR

placebo administered subcutaneously once or twice monthly

Drug: Anti-IgE antibody omalizumab or placebo

Interventions

Anti-IgE antibody omalizumab or placeboDRUG

given subcutaneously oce or twice monthly depending on dose

Also known as: Xolair or placebo
12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic sinusitis, as defined by symptoms for greater than 12 weeks, despite treatment
  • Paranasal sinus CT scan showing evidence of chronic sinusitis
  • Positive skin or RAST test to an inhalant allergen
  • Serum total IgE between 30 and 700 International Units/ml
  • Body weight less than 150 kg
  • Impaired quality of life, as measured by the Rhinosinusitis Disability Index (RSDI)

You may not qualify if:

  • Women of childbearing potential not using a contraception method(s) (birth control pills, Depo Provera, double barrier) as well as women who are breastfeeding
  • Known sensitivity to Xolair
  • Patients with severe medical condition(s) that, in the opinion of the investigator, prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease)
  • Use of any other investigational agent in the last 30 days
  • No measurable disability on the RSDI
  • Immunocompromised patients or patients with ciliary disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (24)

  • Benninger MS, Senior BA. The development of the Rhinosinusitis Disability Index. Arch Otolaryngol Head Neck Surg. 1997 Nov;123(11):1175-9. doi: 10.1001/archotol.1997.01900110025004.

    PMID: 9366696BACKGROUND

  • Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002 Jan;126(1):41-7. doi: 10.1067/mhn.2002.121022.

    PMID: 11821764BACKGROUND

  • Busse W, Corren J, Lanier BQ, McAlary M, Fowler-Taylor A, Cioppa GD, van As A, Gupta N. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J Allergy Clin Immunol. 2001 Aug;108(2):184-90. doi: 10.1067/mai.2001.117880.

    PMID: 11496232BACKGROUND

  • Soler M, Matz J, Townley R, Buhl R, O'Brien J, Fox H, Thirlwell J, Gupta N, Della Cioppa G. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. Eur Respir J. 2001 Aug;18(2):254-61. doi: 10.1183/09031936.01.00092101.

    PMID: 11529281BACKGROUND

  • Calhoun KH, Waggenspack GA, Simpson CB, Hokanson JA, Bailey BJ. CT evaluation of the paranasal sinuses in symptomatic and asymptomatic populations. Otolaryngol Head Neck Surg. 1991 Apr;104(4):480-3. doi: 10.1177/019459989110400409.

    PMID: 1903859BACKGROUND

  • Iwabuchi Y, Hanamure Y, Ueno K, Fukuda K, Furuta S. Clinical significance of asymptomatic sinus abnormalities on magnetic resonance imaging. Arch Otolaryngol Head Neck Surg. 1997 Jun;123(6):602-4. doi: 10.1001/archotol.1997.01900060044007.

    PMID: 9193220BACKGROUND

  • McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA. 1995 Jan 18;273(3):214-9.

    PMID: 7807660BACKGROUND

  • Kaliner MA, Osguthorpe JD, Fireman P, Anon J, Georgitis J, Davis ML, Naclerio R, Kennedy D. Sinusitis: bench to bedside. Current findings, future directions. Otolaryngol Head Neck Surg. 1997 Jun;116(6 Pt 2):S1-20.

    PMID: 9212028BACKGROUND

  • Hamilos DL. Chronic sinusitis. J Allergy Clin Immunol. 2000 Aug;106(2):213-27. doi: 10.1067/mai.2000.109269.

    PMID: 10932063BACKGROUND

  • Iwens P, Clement PA. Sinusitis in allergic patients. Rhinology. 1994 Jun;32(2):65-7.

    PMID: 7939142BACKGROUND

  • Binder E, Holopainen E, Malmberg H, Salo OP. Clinical findings in patients with allergic rhinitis. Rhinology. 1984 Dec;22(4):255-60.

    PMID: 6522975BACKGROUND

  • Rachelefsky GS, Goldberg M, Katz RM, Boris G, Gyepes MT, Shapiro MJ, Mickey MR, Finegold SM, Siegel SC. Sinus disease in children with respiratory allergy. J Allergy Clin Immunol. 1978 May;61(5):310-4. doi: 10.1016/0091-6749(78)90052-0. No abstract available.

    PMID: 641266BACKGROUND

  • Holzmann D, Willi U, Nadal D. Allergic rhinitis as a risk factor for orbital complication of acute rhinosinusitis in children. Am J Rhinol. 2001 Nov-Dec;15(6):387-90.

    PMID: 11777246BACKGROUND

  • Chen CF, Wu KG, Hsu MC, Tang RB. Prevalence and relationship between allergic diseases and infectious diseases. J Microbiol Immunol Infect. 2001 Mar;34(1):57-62.

    PMID: 11321129BACKGROUND

  • VAN DISHOECK HA, FRANSSEN MG. The incidence and correlation of allergy and chronic maxillary sinusitis. Pract Otorhinolaryngol (Basel). 1957 Nov;19(6):502-6. doi: 10.1159/000274105. No abstract available.

    PMID: 13494297BACKGROUND

  • Friedman WH. Surgery for chronic hyperplastic rhinosinusitis. Laryngoscope. 1975 Dec;85(12 pt 1):1999-2011. doi: 10.1288/00005537-197512000-00005.

    PMID: 1202305BACKGROUND

  • Enberg RN. Perennial nonallergic rhinitis: a retrospective review. Ann Allergy. 1989 Dec;63(6 Pt 1):513-6.

    PMID: 2480728BACKGROUND

  • Conner BL, Roach ES, Laster W, Georgitis JW. Magnetic resonance imaging of the paranasal sinuses: frequency and type of abnormalities. Ann Allergy. 1989 May;62(5):457-60.

    PMID: 2719356BACKGROUND

  • Settipane GA, Chafee FH. Nasal polyps in asthma and rhinitis. A review of 6,037 patients. J Allergy Clin Immunol. 1977 Jan;59(1):17-21. doi: 10.1016/0091-6749(77)90171-3.

    PMID: 833373BACKGROUND

  • Holmberg K, Juliusson S, Balder B, Smith DL, Richards DH, Karlsson G. Fluticasone propionate aqueous nasal spray in the treatment of nasal polyposis. Ann Allergy Asthma Immunol. 1997 Mar;78(3):270-6. doi: 10.1016/s1081-1206(10)63180-8.

    PMID: 9087151BACKGROUND

  • Lund VJ, Flood J, Sykes AP, Richards DH. Effect of fluticasone in severe polyposis. Arch Otolaryngol Head Neck Surg. 1998 May;124(5):513-8. doi: 10.1001/archotol.124.5.513.

    PMID: 9604976BACKGROUND

  • Karlsson G, Holmberg K. Does allergic rhinitis predispose to sinusitis? Acta Otolaryngol Suppl. 1994;515:26-8; discussion 29. doi: 10.3109/00016489409124319.

    PMID: 8067239BACKGROUND

  • Kingdom TT, Lee KC, FitzSimmons SC, Cropp GJ. Clinical characteristics and genotype analysis of patients with cystic fibrosis and nasal polyposis requiring surgery. Arch Otolaryngol Head Neck Surg. 1996 Nov;122(11):1209-13. doi: 10.1001/archotol.1996.01890230055011.

    PMID: 8906056BACKGROUND

  • Pinto JM, Mehta N, DiTineo M, Wang J, Baroody FM, Naclerio RM. A randomized, double-blind, placebo-controlled trial of anti-IgE for chronic rhinosinusitis. Rhinology. 2010 Sep;48(3):318-24. doi: 10.4193/Rhino09.144.

    PMID: 21038023DERIVED

MeSH Terms

Conditions

Sinusitis

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Robert M Naclerio, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 7, 2005

Study Start

July 1, 2005

Primary Completion

May 1, 2007

Study Completion

January 1, 2009

Last Updated

September 30, 2013

Record last verified: 2013-09

Locations

US(1)