Allergic RhinitisNCT00604786
The Effect of Omalizumab on Responses to Cat Allergen Challenge
A study testing omalizumab in people with Allergic Rhinitis, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to understand and provide informed consent
- Male or Female (non-pregnant), age 18-50
- Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using a medically acceptable form of birth control throughout the duration of the study.
- Clinical history of seasonal or perennial allergic rhinitis for at least two years, with or without mild persistent asthma
- Positive puncture skin test greater than or equal to 5 mm diluent control
- Positive Immunocap to Fel d 1 > 0.35 kallikrein unit/L
Show all 10Show fewer
- Positive intranasal cat allergen challenge as defined by > 5 sneezes or a tripling of measured nasal lavage mediators
- In vitro assay of basophil responsiveness to cat allergen with greater than 20% histamine release
- The use of antihistamines, cromolyn, leukotriene modifiers and other non-steroid (astelin and topical decongestants), nasal medications will be allowed, but they will be withheld for 5 days prior to each nasal allergen provocation session. Inhaled corticosteroids for mild asthma will be permissible.
- No known contraindications to therapy with omalizumab
Who cannot join
- Asthma with forced expiratory volume at one second (FEV1) < 80%, moderate to severe asthma classification per National Asthma Education and Prevention Program Expert Panel (NAEP) Standards (1997 National Asthma Education and Prevention Program Expert Panel Report II guidelines)
- Serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment will be excluded
- Unexplained elevation of erythrocyte sedimentation rate (ESR), hematocrit < 32%, white blood cell (WBC) count 2400/microliter lower limit of normal, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or aspartate aminotransferase (AST) > 100 IU/L
- Body weight less than 30 kg or greater than 150 kg will be excluded.
- Plans to become pregnant or breastfeed will be excluded from the study
- A perforated nasal septum, structural nasal defect, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis
Show all 17Show fewer
- A life expectancy less than 6 months
- A terminal illness as determined by the investigator
- A history of malignancy, anaphylaxis or bleeding disorder are also exclusion illnesses.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Use of any investigational drugs within 8 weeks of participation
- Contraindications to omalizumab include patients with a previous hypersensitivity to omalizumab
- Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist.
- Prior use of omalizumab
- Frequent sinusitis (>2/ documented episodes per year) or active sinusitis within 2 weeks of enrollment
- Use of immunotherapy within the last 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224
About this study
Official title: Pilot Study of the Effect of Omalizumab on Basophil and Mast Responses to Intranasal Cat Allergen Challenge
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies. The investigators predict that cells in the blood will be effected before cells in the nose or skin.
Read the detailed description
Omalizumab is a monoclonal antibody directed against Immunoglobulin E (IgE) and is FDA-approved for use in allergic asthma, though its clinical role is not precisely defined. It binds IgE on the same site of the Fc domain as the high affinity IgE receptor (FcεRI), and therefore, blocks the interaction between IgE and mast cells or basophils. It, therefore, may be used as a mechanistic tool in the study of IgE. As IgE levels are reduced with omalizumab, FcεRI expression on human basophils is reduced. This reduction of basophil receptors and allergen induced activation is pronounced within 7 days of the initial administration and is reversible once omalizumab administration is discontinued. The omalizumab-induced reductions in mast cell FcεRI expression and function is unchanged at day 7 and significantly reduced by day 70. These changes were based upon intravenously administered omalizumab at a dose of 0.03 mg/kg/IU IgE/mL in a total of three subjects. We propose to exploit the kinetics of faster omalizumab effects on circulating basophils relative to tissue mast cells to elucidate the role of the basophil versus mast cell activation in nasal airway allergen challenge, which has not been studied to date.
- Conditions
- Allergic Rhinitis
- Being tested
- omalizumab, placebo
- Keywords
- Basophils, Mast Cells, IgE, IgE receptors, omalizumab
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
Also called Xolair
Dosing is based on IgE level and weight given every 2 or 4 weeks
placeboDrug
Dosing is based on IgE level and weight given every 2 or 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab subcutaneous | Experimental | This active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).
The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks Receives: Drug: omalizumab |
| Placebo Subcutaneous | Placebo comparator | This placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections).
The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Basophil Surface IgE
Flow cytometry in mean fluorescence units.
100%*[(3.5 month value minus baseline value)/baseline value]
Measured: Change from baseline to 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarbjit S Saini, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604786
- Sponsor's protocol ID
- NA_00007520
- Other IDs
- U19AI070345
- Status last verified
- Apr 2017
- First submitted
- 4 Jan 2008
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Strunk RC, Bloomberg GR. Omalizumab for asthma. N Engl J Med. 2006 Jun 22;354(25):2689-95. doi: 10.1056/NEJMct055184. No abstract available.
PubMed 16790701Presta LG, Lahr SJ, Shields RL, Porter JP, Gorman CM, Fendly BM, Jardieu PM. Humanization of an antibody directed against IgE. J Immunol. 1993 Sep 1;151(5):2623-32.
PubMed 8360482Schulman ES. Development of a monoclonal anti-immunoglobulin E antibody (omalizumab) for the treatment of allergic respiratory disorders. Am J Respir Crit Care Med. 2001 Oct 15;164(8 Pt 2):S6-11. doi: 10.1164/ajrccm.164.supplement_1.2103025.
PubMed 11704611MacGlashan DW Jr, Bochner BS, Adelman DC, Jardieu PM, Togias A, McKenzie-White J, Sterbinsky SA, Hamilton RG, Lichtenstein LM. Down-regulation of Fc(epsilon)RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J Immunol. 1997 Feb 1;158(3):1438-45.
PubMed 9013989Saini SS, MacGlashan DW Jr, Sterbinsky SA, Togias A, Adelman DC, Lichtenstein LM, Bochner BS. Down-regulation of human basophil IgE and FC epsilon RI alpha surface densities and mediator release by anti-IgE-infusions is reversible in vitro and in vivo. J Immunol. 1999 May 1;162(9):5624-30.
PubMed 10228046Beck LA, Marcotte GV, MacGlashan D, Togias A, Saini S. Omalizumab-induced reductions in mast cell Fce psilon RI expression and function. J Allergy Clin Immunol. 2004 Sep;114(3):527-30. doi: 10.1016/j.jaci.2004.06.032.
PubMed 15356552Proud D, Bailey GS, Naclerio RM, Reynolds CJ, Cruz AA, Eggleston PA, Lichtenstein LM, Togias AG. Tryptase and histamine as markers to evaluate mast cell activation during the responses to nasal challenge with allergen, cold, dry air, and hyperosmolar solutions. J Allergy Clin Immunol. 1992 Jun;89(6):1098-110. doi: 10.1016/0091-6749(92)90293-b.
PubMed 1607547Nathan RA, Eccles R, Howarth PH, Steinsvag SK, Togias A. Objective monitoring of nasal patency and nasal physiology in rhinitis. J Allergy Clin Immunol. 2005 Mar;115(3 Suppl 1):S442-59. doi: 10.1016/j.jaci.2004.12.015.
PubMed 15746882Naclerio RM, Proud D, Togias AG, Adkinson NF Jr, Meyers DA, Kagey-Sobotka A, Plaut M, Norman PS, Lichtenstein LM. Inflammatory mediators in late antigen-induced rhinitis. N Engl J Med. 1985 Jul 11;313(2):65-70. doi: 10.1056/NEJM198507113130201.
PubMed 2582257Lin H, Boesel KM, Griffith DT, Prussin C, Foster B, Romero FA, Townley R, Casale TB. Omalizumab rapidly decreases nasal allergic response and FcepsilonRI on basophils. J Allergy Clin Immunol. 2004 Feb;113(2):297-302. doi: 10.1016/j.jaci.2003.11.044.
PubMed 14767445Hanf G, Noga O, O'Connor A, Kunkel G. Omalizumab inhibits allergen challenge-induced nasal response. Eur Respir J. 2004 Mar;23(3):414-8. doi: 10.1183/09031936.04.00024504.
PubMed 15065831Corren J, Diaz-Sanchez D, Saxon A, Deniz Y, Reimann J, Sinclair D, Davancaze T, Adelman D. Effects of omalizumab, a humanized monoclonal anti-IgE antibody, on nasal reactivity to allergen and local IgE synthesis. Ann Allergy Asthma Immunol. 2004 Sep;93(3):243-8. doi: 10.1016/S1081-1206(10)61495-0.
PubMed 15478383Pods R, Ross D, van Hulst S, Rudack C, Maune S. RANTES, eotaxin and eotaxin-2 expression and production in patients with aspirin triad. Allergy. 2003 Nov;58(11):1165-70. doi: 10.1034/j.1398-9995.2003.00276.x.
PubMed 14616128Berkman N, Ohnona S, Chung FK, Breuer R. Eotaxin-3 but not eotaxin gene expression is upregulated in asthmatics 24 hours after allergen challenge. Am J Respir Cell Mol Biol. 2001 Jun;24(6):682-7. doi: 10.1165/ajrcmb.24.6.4301.
PubMed 11415932Salib RJ, Lau LC, Howarth PH. Nasal lavage fluid concentrations of eotaxin-1 (CCL11) in naturally occurring allergic rhinitis: relationship to disease activity, nasal luminal eosinophil influx, and plasma protein exudation. Clin Exp Allergy. 2005 Aug;35(8):995-1002. doi: 10.1111/j.1365-2222.2005.02236.x.
PubMed 16120080
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Omalizumab on Basophil and Mast Responses to Intranasal Cat Allergen Challenge
- ClinicalTrials.gov ID
- NCT00604786
- Acronym / sponsor ID
- NA_00007520
- Conditions
- Allergic Rhinitis
- Keywords
- Basophils, Mast Cells, IgE, IgE receptors, omalizumab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, skin and blood that cause allergies. The investigators predict that cells in the blood will be effected before cells in the nose or skin.
Detailed description
Omalizumab is a monoclonal antibody directed against Immunoglobulin E (IgE) and is FDA-approved for use in allergic asthma, though its clinical role is not precisely defined. It binds IgE on the same site of the Fc domain as the high affinity IgE receptor (FcεRI), and therefore, blocks the interaction between IgE and mast cells or basophils. It, therefore, may be used as a mechanistic tool in the study of IgE. As IgE levels are reduced with omalizumab, FcεRI expression on human basophils is reduced. This reduction of basophil receptors and allergen induced activation is pronounced within 7 days of the initial administration and is reversible once omalizumab administration is discontinued. The omalizumab-induced reductions in mast cell FcεRI expression and function is unchanged at day 7 and significantly reduced by day 70. These changes were based upon intravenously administered omalizumab at a dose of 0.03 mg/kg/IU IgE/mL in a total of three subjects. We propose to exploit the kinetics of faster omalizumab effects on circulating basophils relative to tissue mast cells to elucidate the role of the basophil versus mast cell activation in nasal airway allergen challenge, which has not been studied to date.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omalizumab subcutaneous | Experimental | Drug: omalizumabThis active are will receive treatment with omalizumab subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks |
| Placebo Subcutaneous | Placebo comparator | Drug: placeboThis placebo arm will receive identical treatment with placebo injections subcutaneously at the dose currently FDA-approved for the treatment of allergic asthma. There is a weight and IgE based dosing table in the and subjects receive therapy by subcutaneous injection every 2 or 4 weeks. The lower range of dosing is 150 mg q 4weeks ( one injection) with the upper range 375 mg every 2 weeks ( three injections). The dosing is based on IgE levels and IGE and is given by subcutaneous injection every 2 to 4 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Ability to understand and provide informed consent
- Male or Female (non-pregnant), age 18-50
- Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using a medically acceptable form of birth control throughout the duration of the study.
- Clinical history of seasonal or perennial allergic rhinitis for at least two years, with or without mild persistent asthma
- Positive puncture skin test greater than or equal to 5 mm diluent control
Key exclusion criteria (17 listed)
- Asthma with forced expiratory volume at one second (FEV1) < 80%, moderate to severe asthma classification per National Asthma Education and Prevention Program Expert Panel (NAEP) Standards (1997 National Asthma Education and Prevention Program Expert Panel Report II guidelines)
- Serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment will be excluded
- Unexplained elevation of erythrocyte sedimentation rate (ESR), hematocrit < 32%, white blood cell (WBC) count 2400/microliter lower limit of normal, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or aspartate aminotransferase (AST) > 100 IU/L
- Body weight less than 30 kg or greater than 150 kg will be excluded.
- Plans to become pregnant or breastfeed will be excluded from the study
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 |
|---|---|---|
| omalizumabAlso: XolairDosing is based on IgE level and weight given every 2 or 4 weeks | Drug | Omalizumab subcutaneous |
| placeboDosing is based on IgE level and weight given every 2 or 4 weeks | Drug | Placebo Subcutaneous |
Primary outcome
Change in Basophil Surface IgE
Time frame: Change from baseline to 3.5 months
Flow cytometry in mean fluorescence units. 100%*[(3.5 month value minus baseline value)/baseline value]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16790701Strunk RC, Bloomberg GR. Omalizumab for asthma. N Engl J Med. 2006 Jun 22;354(25):2689-95. doi: 10.1056/NEJMct055184. No abstract available.
- Background: PubMed 8360482Presta LG, Lahr SJ, Shields RL, Porter JP, Gorman CM, Fendly BM, Jardieu PM. Humanization of an antibody directed against IgE. J Immunol. 1993 Sep 1;151(5):2623-32.
- Background: PubMed 11704611Schulman ES. Development of a monoclonal anti-immunoglobulin E antibody (omalizumab) for the treatment of allergic respiratory disorders. Am J Respir Crit Care Med. 2001 Oct 15;164(8 Pt 2):S6-11. doi: 10.1164/ajrccm.164.supplement_1.2103025.
- Background: PubMed 9013989MacGlashan DW Jr, Bochner BS, Adelman DC, Jardieu PM, Togias A, McKenzie-White J, Sterbinsky SA, Hamilton RG, Lichtenstein LM. Down-regulation of Fc(epsilon)RI expression on human basophils during in vivo treatment of atopic patients with anti-IgE antibody. J Immunol. 1997 Feb 1;158(3):1438-45.
- Background: PubMed 10228046Saini SS, MacGlashan DW Jr, Sterbinsky SA, Togias A, Adelman DC, Lichtenstein LM, Bochner BS. Down-regulation of human basophil IgE and FC epsilon RI alpha surface densities and mediator release by anti-IgE-infusions is reversible in vitro and in vivo. J Immunol. 1999 May 1;162(9):5624-30.
- Background: PubMed 15356552Beck LA, Marcotte GV, MacGlashan D, Togias A, Saini S. Omalizumab-induced reductions in mast cell Fce psilon RI expression and function. J Allergy Clin Immunol. 2004 Sep;114(3):527-30. doi: 10.1016/j.jaci.2004.06.032.
- Background: PubMed 1607547Proud D, Bailey GS, Naclerio RM, Reynolds CJ, Cruz AA, Eggleston PA, Lichtenstein LM, Togias AG. Tryptase and histamine as markers to evaluate mast cell activation during the responses to nasal challenge with allergen, cold, dry air, and hyperosmolar solutions. J Allergy Clin Immunol. 1992 Jun;89(6):1098-110. doi: 10.1016/0091-6749(92)90293-b.
- Background: PubMed 15746882Nathan RA, Eccles R, Howarth PH, Steinsvag SK, Togias A. Objective monitoring of nasal patency and nasal physiology in rhinitis. J Allergy Clin Immunol. 2005 Mar;115(3 Suppl 1):S442-59. doi: 10.1016/j.jaci.2004.12.015.
- Background: PubMed 2582257Naclerio RM, Proud D, Togias AG, Adkinson NF Jr, Meyers DA, Kagey-Sobotka A, Plaut M, Norman PS, Lichtenstein LM. Inflammatory mediators in late antigen-induced rhinitis. N Engl J Med. 1985 Jul 11;313(2):65-70. doi: 10.1056/NEJM198507113130201.
- Background: PubMed 14767445Lin H, Boesel KM, Griffith DT, Prussin C, Foster B, Romero FA, Townley R, Casale TB. Omalizumab rapidly decreases nasal allergic response and FcepsilonRI on basophils. J Allergy Clin Immunol. 2004 Feb;113(2):297-302. doi: 10.1016/j.jaci.2003.11.044.
- Background: PubMed 15065831Hanf G, Noga O, O'Connor A, Kunkel G. Omalizumab inhibits allergen challenge-induced nasal response. Eur Respir J. 2004 Mar;23(3):414-8. doi: 10.1183/09031936.04.00024504.
- Background: PubMed 15478383Corren J, Diaz-Sanchez D, Saxon A, Deniz Y, Reimann J, Sinclair D, Davancaze T, Adelman D. Effects of omalizumab, a humanized monoclonal anti-IgE antibody, on nasal reactivity to allergen and local IgE synthesis. Ann Allergy Asthma Immunol. 2004 Sep;93(3):243-8. doi: 10.1016/S1081-1206(10)61495-0.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
Sarbjit S Saini, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omalizumab in people with Allergic Rhinitis, run by Johns Hopkins University 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 10 inclusion and 17 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 10 May 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Basophil Surface IgE (time frame: Change from baseline to 3.5 months). 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 NCT00604786, which also lists 26 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 10 May 2017.