SinusitisPhase 4NCT00117611
Xolair in Patients With Chronic Sinusitis
A Phase 4 study of Sinusitis, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sinusitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
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.
Read the detailed description
At its most basic level, sinusitis is defined as an inflammation of the lining membrane of the paranasal sinuses. Sinusitis affects all age groups, including 17% of people above the age of 65 years. On the basis of national population surveys and insurance-reimbursement claims, sinusitis is one of the most common health problems in the U.S. Thus, each year, billions of dollars are spent on direct medical costs for the treatment of this enigmatic illness.
Despite the enormous cost of the problem, there are no definite studies of treatment and management. There are some data indicating that intranasal steroids are effective, and recently Nasonex was approved for the treatment of nasal polyps. All other treatments are empirically based.
There is evidence that IgE antibodies play a role in chronic sinusitis. The investigators have shown that total IgE levels correlate with the severity of sinusitis, as assessed by CT scan. Staphylococcus enterotoxins cause local increases in total IgE in over 50% of nasal polyp patients. Allergies occur more frequently in patients with chronic sinusitis than in the general population. Elevations in total IgE have been shown to occur in patients with allergic fungal sinusitis and the levels of total IgE decrease with successful treatment. Thus, the investigators speculate that IgE contributes significantly to the pathogenesis of chronic sinusitis.
The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair, will improve objective and subjective evidence of chronic sinusitis.
- Conditions
- Sinusitis
- Being tested
- Anti-IgE antibody omalizumab or placebo
- Keywords
- chronic sinusitis
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-IgE antibody omalizumab or placeboDrug
Also called Xolair or placebo
given subcutaneously oce or twice monthly depending on dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Xolair administered subcutaneously, once or twice monthly (dose dependent on subject weight and serum IgE level) Receives: Drug: Anti-IgE antibody omalizumab or placebo |
| 2 | Placebo comparator | placebo administered subcutaneously once or twice monthly Receives: Drug: Anti-IgE antibody omalizumab or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal thickness on CT scan
Measured: after 6 months of treatment
Secondary outcomes (9)
Rhinosinusitis Disability Index (RSDI)recorded monthly
Measured: 6 months
A specific quality of life (QOL) measure, Sino-Nasal Outcome Test (SNOT 20)recorded monthly
Measured: 6 months
A general health QOL measure (SF-36)
Measured: 6 months
The number of sinusitis exacerbations requiring additional treatment
Measured: 6 months
Nasal peak inspiratory flow
Measured: 6 months
Symptoms of nasal discharge, nasal obstruction, facial pain and altered smell
Measured: 6 months
Nasal lavage eosinophils
Measured: 6 months
Nasal endoscopy score
Measured: 6 months
The University of Pennsylvania Smell Identification Test (UPSIT)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionMay 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117611
- Sponsor's protocol ID
- 13916A
- Other IDs
- Q2347s
- Status last verified
- Sep 2013
- First submitted
- 30 Jun 2005
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9366696Piccirillo 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.
PubMed 11821764Busse 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.
PubMed 11496232Soler 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.
PubMed 11529281Calhoun 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.
PubMed 1903859Iwabuchi 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.
PubMed 9193220McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA. 1995 Jan 18;273(3):214-9.
PubMed 7807660Kaliner 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.
PubMed 9212028Hamilos DL. Chronic sinusitis. J Allergy Clin Immunol. 2000 Aug;106(2):213-27. doi: 10.1067/mai.2000.109269.
PubMed 10932063Iwens P, Clement PA. Sinusitis in allergic patients. Rhinology. 1994 Jun;32(2):65-7.
PubMed 7939142Binder E, Holopainen E, Malmberg H, Salo OP. Clinical findings in patients with allergic rhinitis. Rhinology. 1984 Dec;22(4):255-60.
PubMed 6522975Rachelefsky 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.
PubMed 641266Holzmann 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.
PubMed 11777246Chen 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.
PubMed 11321129VAN 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.
PubMed 13494297
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-IgE Antibody Omalizumab (Xolair) on Patients With Chronic Sinusitis and a Positive Allergen Test
- ClinicalTrials.gov ID
- NCT00117611
- Acronym / sponsor ID
- 13916A
- Conditions
- Sinusitis
- Keywords
- chronic sinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Genentech, Inc., Novartis Pharmaceuticals
- Study start
- Jul 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At its most basic level, sinusitis is defined as an inflammation of the lining membrane of the paranasal sinuses. Sinusitis affects all age groups, including 17% of people above the age of 65 years. On the basis of national population surveys and insurance-reimbursement claims, sinusitis is one of the most common health problems in the U.S. Thus, each year, billions of dollars are spent on direct medical costs for the treatment of this enigmatic illness.
Despite the enormous cost of the problem, there are no definite studies of treatment and management. There are some data indicating that intranasal steroids are effective, and recently Nasonex was approved for the treatment of nasal polyps. All other treatments are empirically based.
There is evidence that IgE antibodies play a role in chronic sinusitis. The investigators have shown that total IgE levels correlate with the severity of sinusitis, as assessed by CT scan. Staphylococcus enterotoxins cause local increases in total IgE in over 50% of nasal polyp patients. Allergies occur more frequently in patients with chronic sinusitis than in the general population. Elevations in total IgE have been shown to occur in patients with allergic fungal sinusitis and the levels of total IgE decrease with successful treatment. Thus, the investigators speculate that IgE contributes significantly to the pathogenesis of chronic sinusitis.
The purpose of this study is to determine if treatment with the anti-IgE antibody, Xolair, will improve objective and subjective evidence of chronic sinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Anti-IgE antibody omalizumab or placeboXolair administered subcutaneously, once or twice monthly (dose dependent on subject weight and serum IgE level) |
| 2 | Placebo comparator | Drug: Anti-IgE antibody omalizumab or placeboplacebo administered subcutaneously once or twice monthly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-IgE antibody omalizumab or placeboAlso: Xolair or placebogiven subcutaneously oce or twice monthly depending on dose | Drug | 1, 2 |
Primary outcome
Mucosal thickness on CT scan
Time frame: after 6 months of treatment
9 secondary outcomes
Rhinosinusitis Disability Index (RSDI)recorded monthly
Time frame: 6 months
A specific quality of life (QOL) measure, Sino-Nasal Outcome Test (SNOT 20)recorded monthly
Time frame: 6 months
A general health QOL measure (SF-36)
Time frame: 6 months
The number of sinusitis exacerbations requiring additional treatment
Time frame: 6 months
Nasal peak inspiratory flow
Time frame: 6 months
Symptoms of nasal discharge, nasal obstruction, facial pain and altered smell
Time frame: 6 months
Nasal lavage eosinophils
Time frame: 6 months
Nasal endoscopy score
Time frame: 6 months
The University of Pennsylvania Smell Identification Test (UPSIT)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Background: PubMed 9366696Benninger 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.
- Background: PubMed 11821764Piccirillo 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.
- Background: PubMed 11496232Busse 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.
- Background: PubMed 11529281Soler 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.
- Background: PubMed 1903859Calhoun 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.
- Background: PubMed 9193220Iwabuchi 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.
- Background: PubMed 7807660McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA. 1995 Jan 18;273(3):214-9.
- Background: PubMed 9212028Kaliner 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.
- Background: PubMed 10932063Hamilos DL. Chronic sinusitis. J Allergy Clin Immunol. 2000 Aug;106(2):213-27. doi: 10.1067/mai.2000.109269.
- Background: PubMed 7939142Iwens P, Clement PA. Sinusitis in allergic patients. Rhinology. 1994 Jun;32(2):65-7.
- Background: PubMed 6522975Binder E, Holopainen E, Malmberg H, Salo OP. Clinical findings in patients with allergic rhinitis. Rhinology. 1984 Dec;22(4):255-60.
- Background: PubMed 641266Rachelefsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Naclerio, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Sinusitis, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal thickness on CT scan (time frame: after 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00117611, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2013.