Nasal PolyposisPhase 2NCT01393340
Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma
A Phase 2 study testing Omalizumab in people with Nasal Polyposis and Asthma, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyposis, Asthma
- 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
- 23 participants
- Where
- 2 sitesBelgium
- Study dates
- Dec 2006to Dec 2009
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be at least 18 years of age, of either gender and any race.
- Subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system described in table 5. Bilateral nasal polyposis is defined as sinus symptoms for more than 3 months, bilateral opacity on CT-scan imaging and visible nasal polyps at endoscopy.
- Subjects must have a diagnosis of asthma for more than 2 years. Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
- Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
- Subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
- Clinical laboratory tests must be within normal limits or clinically acceptable for the investigator.
- Non-pregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. This includes: a) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); b) medically prescribed Intra-Uterine Device (IUD); c) condom in combination with a spermicide; d) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus spermicide during the study. They must have started this birth control method at least three months prior to screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for at least 3 months after last dosing. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. Women who are surgically sterilized or are at least one year postmenopausal are considered not to be of childbearing potential. However, all female subjects must have a urine pregnancy test prior to treatment, which must be negative. A monthly-control pregnancy test is requested.
- Male subjects must agree to use an adequate form of birth control from first dosing to at least 3 months after last dosing. They must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described above.
Who cannot join
- Women must not be pregnant, breast feeding, or premenarcheal.
- Patients younger than 18 years old.
- Subjects with history of systemic reactions to the study medication.
- Subjects with prohibited medication at screening without full wash-out period.
- Subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within two weeks of the inclusion are excluded.
- Subjects with cystic fibrosis, primary ciliary's dysfunction or Kartagener's syndrome by history are excluded.
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- Subjects must not have ever been diagnosed with a parasitic infection.
- Subjects must not have ever been diagnosed with cancer
- Subjects must not have a medical history of Human Immunodeficiency Virus (HIV) or hepatitis B or C. Testing will not be done at screening.
- Subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency room visits which resulted in direct discharge without hospitalization) within the four weeks prior to screening.
- Subjects must not have received specific immunotherapy within the previous three months.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital, Ghent
Ghent, 9000
UZ Gasthuisberg
Leuven, 3000
About this study
This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE). During the treatment period and follow-up, the clinical efficacy of the treatment will be assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and spirometry. Biological activity will be evaluated by measuring peripheral and local (in serum, in nasal secretions, biopsies) markers of inflammation.
Study hypothesis
- Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal polyposis and comorbid asthma.
- Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal polyposis
- Clinical assessment of the IgE theory in the pathogenesis of nasal polyps
- Conditions
- Nasal Polyposis, Asthma
- Being tested
- Omalizumab, Placebo
- Medical subject headings
- Nasal Polyps, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Omalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE. Molecular weight is approximately 149 kilodaltons. Xolair(R) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial, reconstituted with Sterile Water For Injection (SWFI), and administered as subcutaneous (SC) injection.
Xolair(R) will be administered subcutaneously in a dose of 75 to 375mg every 2 to 4 weeks. Doses (mg) and dosing frequency are determined by total serum IgE level (IU/ml) measured at the start of treatment and body weight (kg). During this 20-week during trial patients will receive 4 or 8 doses of omalizumab.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Omalizumab | Active comparator | Not described Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Omalizumab on nasal polyp size and evolution of nasal polyps
Nasal examination at all visits by endoscopy of each nasal fossa. Polyps will be graded by the Modified DAVOS score
Measured: At every study visit starting from week 0 until week 20
Secondary outcomes (11)
Effect of Omalizumab on rhinosinusitis symptoms:nasal discharge, nasal congestion, postnasal drip scores: Subject's Diary
Dispense / collect / review diary
Measured: At screening visit, baseline visit and at week 0, 4, 8, 12, 16, 20
Effect of Omalizumab on asthma symptom scores including cough, wheeze, dyspnoea: Subject's Diary.
Dispense / collect / review diary
Measured: At screening visit, baseline visit and at week 0, 4, 8, 12, 16, 20
Effect of Omalizumab on sinus computed tomography (CT)-scan score : Sinus CT-scan evaluation
Sinus CT-scan evaluation
Measured: Visit before dosing and at week 16
Effect of Omalizumab on smell: UPSIT (University of Pennsylvania Smell Identification Test)
Olfactory test
Measured: Baseline visit and at week 10
Effect of Omalizumab on Rhinitis specific Quality of Life: Rhinosinusitis Outcome Measure (RSOM-31)
Measured: At baseline visit
Effect of Omalizumab on asthma related Quality of life: Asthma Quality of Life Questionnaire (AQLQ)
Measured: At baseline visit
Effect of Omalizumab on overall Quality of Life: The Short Form (36) Health Survey (SF-36)
Measured: At baseline visit
Effect of Omalizumab on peak nasal inspiratory flow
Measured: On screening visit, baseline visit and on week 4,8,12, 16 and 20
Effect of Omalizumab and Forced Expiratory Volume in 1 second (FEV1): spirometry
Measured: At screening visit, baseline visit and week 16 and 20
Effect of Omalizumab on diverse inflammatory mediators in serum, in nasal fluid (eosinophilic cationic protein (ECP), Interleukin-2 receptor (IL-2R), Sol Interleukin-5 receptor, soluble Cluster of differentiation 23 (sCD23), tryptase)
Measured: At screening visit, baseline visit and week 4, 8, 12, 16 and 20
Evaluation of adverse events, directly or by general physical examination, blood sampling , review of concomitant medication or symptom scores.
Measured: week 2, 4, 6, 8, 10, 12, 14, 16, 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startDec 2006
- Primary completionOct 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal PolyposisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharma AG, Switzerland
- Investigators
- Paul Van Cauwenberge, PhD, MD, Principal investigator, University Hospital, Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393340
- Sponsor's protocol ID
- 2006/240
- Status last verified
- Jul 2011
- First submitted
- 7 Jul 2011
- Last updated
- 13 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.
PubMed 33710614
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma
- ClinicalTrials.gov ID
- NCT01393340
- Acronym / sponsor ID
- 2006/240
- Conditions
- Nasal Polyposis, Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Novartis Pharma AG, Switzerland
- Study start
- Dec 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Jul 2011 (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.
This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE). During the treatment period and follow-up, the clinical efficacy of the treatment will be assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and spirometry. Biological activity will be evaluated by measuring peripheral and local (in serum, in nasal secretions, biopsies) markers of inflammation.
Study hypothesis
- Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal polyposis and comorbid asthma.
- Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal polyposis
- Clinical assessment of the IgE theory in the pathogenesis of nasal polyps
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Omalizumab | Active comparator | Drug: Omalizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be at least 18 years of age, of either gender and any race.
- Subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system described in table 5. Bilateral nasal polyposis is defined as sinus symptoms for more than 3 months, bilateral opacity on CT-scan imaging and visible nasal polyps at endoscopy.
- Subjects must have a diagnosis of asthma for more than 2 years. Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
- Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
- Subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
Key exclusion criteria (11 listed)
- Women must not be pregnant, breast feeding, or premenarcheal.
- Patients younger than 18 years old.
- Subjects with history of systemic reactions to the study medication.
- Subjects with prohibited medication at screening without full wash-out period.
- Subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within two weeks of the inclusion are excluded.
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 |
|---|---|---|
| OmalizumabOmalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE. Molecular weight is approximately 149 kilodaltons. Xolair(R) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial, reconstituted with Sterile Water For Injection (SWFI), and administered as subcutaneous (SC) injection. Xolair(R) will be administered subcutaneously in a dose of 75 to 375mg every 2 to 4 weeks. Doses (mg) and dosing frequency are determined by total serum IgE level (IU/ml) measured at the start of treatment and body weight (kg). During this 20-week during trial patients will receive 4 or 8 doses of omalizumab. | Drug | Omalizumab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Effect of Omalizumab on nasal polyp size and evolution of nasal polyps
Time frame: At every study visit starting from week 0 until week 20
Nasal examination at all visits by endoscopy of each nasal fossa. Polyps will be graded by the Modified DAVOS score
11 secondary outcomes
Effect of Omalizumab on rhinosinusitis symptoms:nasal discharge, nasal congestion, postnasal drip scores: Subject's Diary
Time frame: At screening visit, baseline visit and at week 0, 4, 8, 12, 16, 20
Effect of Omalizumab on asthma symptom scores including cough, wheeze, dyspnoea: Subject's Diary.
Time frame: At screening visit, baseline visit and at week 0, 4, 8, 12, 16, 20
Effect of Omalizumab on sinus computed tomography (CT)-scan score : Sinus CT-scan evaluation
Time frame: Visit before dosing and at week 16
Effect of Omalizumab on smell: UPSIT (University of Pennsylvania Smell Identification Test)
Time frame: Baseline visit and at week 10
Effect of Omalizumab on Rhinitis specific Quality of Life: Rhinosinusitis Outcome Measure (RSOM-31)
Time frame: At baseline visit
Effect of Omalizumab on asthma related Quality of life: Asthma Quality of Life Questionnaire (AQLQ)
Time frame: At baseline visit
Effect of Omalizumab on overall Quality of Life: The Short Form (36) Health Survey (SF-36)
Time frame: At baseline visit
Effect of Omalizumab on peak nasal inspiratory flow
Time frame: On screening visit, baseline visit and on week 4,8,12, 16 and 20
Effect of Omalizumab and Forced Expiratory Volume in 1 second (FEV1): spirometry
Time frame: At screening visit, baseline visit and week 16 and 20
Effect of Omalizumab on diverse inflammatory mediators in serum, in nasal fluid (eosinophilic cationic protein (ECP), Interleukin-2 receptor (IL-2R), Sol Interleukin-5 receptor, soluble Cluster of differentiation 23 (sCD23), tryptase)
Time frame: At screening visit, baseline visit and week 4, 8, 12, 16 and 20
Evaluation of adverse events, directly or by general physical examination, blood sampling , review of concomitant medication or symptom scores.
Time frame: week 2, 4, 6, 8, 10, 12, 14, 16, 20
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 13 Jul 2011.
- Derived from this study: PubMed 33710614Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Paul Van Cauwenberge, PhD, MD principal investigator
University Hospital, Ghent, Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab in people with Nasal Polyposis and Asthma, run by University Hospital, Ghent at 2 sites in Belgium.
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 8 inclusion and 11 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 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Effect of Omalizumab on nasal polyp size and evolution of nasal polyps (time frame: At every study visit starting from week 0 until week 20). 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 NCT01393340, which also lists 1 linked publication.
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 13 Jul 2011.