Aspirin-exacerbated Respiratory DiseasePhase 2NCT03595488
Dupilumab for Aspirin-exacerbated Respiratory Disease
A Phase 2 study testing Dupilumab in people with Aspirin-exacerbated Respiratory Disease, run by Rochester General Hospital at 1 site in United States.
Trial summary
Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aspirin-exacerbated Respiratory Disease
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 11 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years and older with a physician diagnosis of aspirin-exacerbated respiratory disease, as defined by a physician diagnosis of asthma, chronic rhinosinusitis with nasal polyposis, and a convincing clinical history of NSAID sensitivity
- All subjects must have a SNOT 22 score ≥ 19 despite standard medical therapy. This minimal SNOT 22 was calculated by taking the range of SNOT 22 scores in studies of normal controls plus 8.9, which is the minimal clinically meaningful improvement in SNOT 22 score detected by patients.
- Able to understand and willingness to sign informed consent
- Able to comply with study procedures
Who cannot join
- Patient < 18 years of age
- Pregnancy or breast feeding
- Current tobacco use
- Significant, uncontrolled medical conditions
- Ongoing malignancy or history of malignancy in remission within the past 12 months
- Current treatment with immunosuppressive medications except chronic oral steroids
- Currently increasing dose of aeroallergen immunotherapy (patients on stable dose of aeroallergen immunotherapy will be allowed to participate)
- Treatment with omalizumab, reslizumab, mepolizumab within 4 months of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester Regional Health - Allergy/Immunology
Rochester, New York, 14607
About this study
Official title: Dupilumab as add-on Therapy for Aspirin-exacerbated Respiratory Disease (AERD)
Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.
Read the detailed description
This is a single blind, placebo controlled trial to be conducted in adult patients with AERD to determine the efficacy and safety of dupilumab in treating symptoms of chronic rhinosinusitis.
All subjects will be treated with the FDA-approved and the commercially available dose for adult atopic dermatitis of 300 mg every 2 weeks administered subcutaneously, based on the observed efficacy and safety of this dose. In addition to atopic dermatitis, this dose has also been shown to be efficacious in adult asthma.15 Patients will not be treated with a loading dose since other studies of dupilumab in asthma and chronic rhinosinusitis with nasal polyposis have not used a loading dose.
There will be a one month screening period to determine the patient's eligibility and establish symptom control and baseline parameters.
Patients will continue their background medications for chronic rhinosinusitis with nasal polyposis and asthma. These medications may include nasal corticosteroids, nasal antihistamines, systemic antihistamines, leukotriene receptor antagonists, 5 lipo-oxygenase inhibitors, inhaled corticosteroids, long-acting beta agonists, and long acting muscarinic antagonists. These controller medications will not be dispensed or supplied by the sponsor.
- Conditions
- Aspirin-exacerbated Respiratory Disease
- Being tested
- Dupilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Matching placebo
dupilumab 300 mg subcutaneous injection every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Single-blinded, Dupilumab or matching placebo will be administered to the patients at the study visits. At each study visit, a single dose of dupilumab or placebo will be dispensed to the patients to be administered at home.
300 mg/2 ml solution in a single-dose pre-filled syringe with needle shield given once every 2 weeks in a subcutaneous injection Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT 22 Score
This is a patient-reported outcome score for chronic rhinosinusitis with or without nasal polyposis
Measured: From baseline to completion of study(7 months total)
Secondary outcomes (14)
UPSIT
Univ. of Pennsylvania smell identification test
Measured: From baseline to completion of study( 7 months total)
Lund Mackay score
Objective score for CT sinus imaging, this is a widely used method for radiologic staging of chronic rhinosinusitis.
Measured: From baseline to completion of study( 7 months total)
ACT score
Validated asthma control test, a series of 5 questions related to patient's asthma control over the previous 4 weeks.
Measured: From baseline to completion of study( 7 months total)
Asthma Mini-AQLQ, 15 questions to assess quality of life. This assessment takes approximately 4-5 minutes to complete the questions.
Validated asthma quality of life score
Measured: From baseline to completion of study( 7 months total)
Change in FEV1
Forced expiratory volume in first second from spirometry
Measured: From baseline to completion of study( 7 months total)
Change in FeNO
Exhaled nitric oxide
Measured: From baseline to completion of study( 7 months total)
Eosinophil count
Absolute eosinophil count
Measured: From baseline to completion of study( 7 months total)
Total serum IgE
Total IgE
Measured: From baseline to completion of study( 7 months total)
Serum tryptase
Biomarker
Measured: From baseline to completion of study( 7 months total)
Serum TARC (thymus and activation regulated cytokine)
Biomarker
Measured: From baseline to completion of study( 7 months total)
Serum prostaglandin D2
Biomarker
Measured: From baseline to completion of study( 7 months total)
24 hour urinary leukotriene E4
Biomarker
Measured: From baseline to completion of study( 7 months total)
To assess the safety and tolerability of dupilumab
Adverse events
Measured: From baseline to completion of study( 7 months total)
To assess cumulative dose of systemic steroids
Impact on systemic steroids
Measured: From baseline to completion of study( 7 months total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start5 Sep 2018
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Aspirin-exacerbated Respiratory DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rochester General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S. Shahzad Mustafa, Rochester General Hospital
- Investigators
- S Shahzad Mustafa, MD, Principal investigator, Lead Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595488
- Sponsor's protocol ID
- 1828-A-18
- Status last verified
- Aug 2020
- First submitted
- 29 Jun 2018
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajan JP, Wineinger NE, Stevenson DD, White AA. Prevalence of aspirin-exacerbated respiratory disease among asthmatic patients: A meta-analysis of the literature. J Allergy Clin Immunol. 2015 Mar;135(3):676-81.e1. doi: 10.1016/j.jaci.2014.08.020. Epub 2014 Oct 3.
PubMed 25282015Mullol J, Picado C. Rhinosinusitis and nasal polyps in aspirin-exacerbated respiratory disease. Immunol Allergy Clin North Am. 2013 May;33(2):163-76. doi: 10.1016/j.iac.2012.11.002. Epub 2012 Dec 23.
PubMed 23639706Ta V, White AA. Survey-Defined Patient Experiences With Aspirin-Exacerbated Respiratory Disease. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):711-8. doi: 10.1016/j.jaip.2015.03.001. Epub 2015 Apr 7.
PubMed 25858054Berges-Gimeno MP, Simon RA, Stevenson DD. Long-term treatment with aspirin desensitization in asthmatic patients with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2003 Jan;111(1):180-6. doi: 10.1067/mai.2003.7.
PubMed 12532116Stevenson DD, Pleskow WW, Simon RA, Mathison DA, Lumry WR, Schatz M, Zeiger RS. Aspirin-sensitive rhinosinusitis asthma: a double-blind crossover study of treatment with aspirin. J Allergy Clin Immunol. 1984 Apr;73(4):500-7. doi: 10.1016/0091-6749(84)90361-0.
PubMed 6368649Swierczynska-Krepa M, Sanak M, Bochenek G, Strek P, Cmiel A, Gielicz A, Plutecka H, Szczeklik A, Nizankowska-Mogilnicka E. Aspirin desensitization in patients with aspirin-induced and aspirin-tolerant asthma: a double-blind study. J Allergy Clin Immunol. 2014 Oct;134(4):883-90. doi: 10.1016/j.jaci.2014.02.041. Epub 2014 Apr 24.
PubMed 24767875Fruth K, Pogorzelski B, Schmidtmann I, Springer J, Fennan N, Fraessdorf N, Boessert A, Schaefer D, Gosepath J, Mann WJ. Low-dose aspirin desensitization in individuals with aspirin-exacerbated respiratory disease. Allergy. 2013;68(5):659-65. doi: 10.1111/all.12131. Epub 2013 Mar 7.
PubMed 23464577Esmaeilzadeh H, Nabavi M, Aryan Z, Arshi S, Bemanian MH, Fallahpour M, Mortazavi N. Aspirin desensitization for patients with aspirin-exacerbated respiratory disease: A randomized double-blind placebo-controlled trial. Clin Immunol. 2015 Oct;160(2):349-57. doi: 10.1016/j.clim.2015.05.012. Epub 2015 Jun 14.
PubMed 26083948Waldram JD, White AA. A survey of aspirin desensitization practices among allergists and fellows in training in the United States. J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1253-1255. doi: 10.1016/j.jaip.2016.06.016. Epub 2016 Jul 21. No abstract available.
PubMed 27452889Samuelsson B, Dahlen SE, Lindgren JA, Rouzer CA, Serhan CN. Leukotrienes and lipoxins: structures, biosynthesis, and biological effects. Science. 1987 Sep 4;237(4819):1171-6. doi: 10.1126/science.2820055.
PubMed 2820055Laidlaw TM, Boyce JA. Aspirin-Exacerbated Respiratory Disease--New Prime Suspects. N Engl J Med. 2016 Feb 4;374(5):484-8. doi: 10.1056/NEJMcibr1514013. No abstract available.
PubMed 26840139Bachert C, Zhang N. Chronic rhinosinusitis and asthma: novel understanding of the role of IgE 'above atopy'. J Intern Med. 2012 Aug;272(2):133-43. doi: 10.1111/j.1365-2796.2012.02559.x.
PubMed 22640264Patou J, Gevaert P, Van Zele T, Holtappels G, van Cauwenberge P, Bachert C. Staphylococcus aureus enterotoxin B, protein A, and lipoteichoic acid stimulations in nasal polyps. J Allergy Clin Immunol. 2008 Jan;121(1):110-5. doi: 10.1016/j.jaci.2007.08.059. Epub 2007 Nov 5.
PubMed 17980412Wenzel S, Ford L, Pearlman D, Spector S, Sher L, Skobieranda F, Wang L, Kirkesseli S, Rocklin R, Bock B, Hamilton J, Ming JE, Radin A, Stahl N, Yancopoulos GD, Graham N, Pirozzi G. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455-66. doi: 10.1056/NEJMoa1304048. Epub 2013 May 21.
PubMed 23688323Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016 Jul 2;388(10039):31-44. doi: 10.1016/S0140-6736(16)30307-5. Epub 2016 Apr 27.
PubMed 27130691
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dupilumab as add-on Therapy for Aspirin-exacerbated Respiratory Disease (AERD)
- ClinicalTrials.gov ID
- NCT03595488
- Acronym / sponsor ID
- 1828-A-18
- Conditions
- Aspirin-exacerbated Respiratory Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Rochester General HospitalUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 23 Jul 2018 (actual)
- 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.
Subjects with physician-diagnosed aspirin-exacerbated respiratory disease (AERD) who remain unacceptably symptomatic with a SNOT 22 score > 18 despite routine medical therapy will be enrolled in this single center, single-blinded study assessing the efficacy of dupilumab in AERD.
Detailed description
This is a single blind, placebo controlled trial to be conducted in adult patients with AERD to determine the efficacy and safety of dupilumab in treating symptoms of chronic rhinosinusitis.
All subjects will be treated with the FDA-approved and the commercially available dose for adult atopic dermatitis of 300 mg every 2 weeks administered subcutaneously, based on the observed efficacy and safety of this dose. In addition to atopic dermatitis, this dose has also been shown to be efficacious in adult asthma.15 Patients will not be treated with a loading dose since other studies of dupilumab in asthma and chronic rhinosinusitis with nasal polyposis have not used a loading dose.
There will be a one month screening period to determine the patient's eligibility and establish symptom control and baseline parameters.
Patients will continue their background medications for chronic rhinosinusitis with nasal polyposis and asthma. These medications may include nasal corticosteroids, nasal antihistamines, systemic antihistamines, leukotriene receptor antagonists, 5 lipo-oxygenase inhibitors, inhaled corticosteroids, long-acting beta agonists, and long acting muscarinic antagonists. These controller medications will not be dispensed or supplied by the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: DupilumabSingle-blinded, Dupilumab or matching placebo will be administered to the patients at the study visits. At each study visit, a single dose of dupilumab or placebo will be dispensed to the patients to be administered at home. 300 mg/2 ml solution in a single-dose pre-filled syringe with needle shield given once every 2 weeks in a subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years and older with a physician diagnosis of aspirin-exacerbated respiratory disease, as defined by a physician diagnosis of asthma, chronic rhinosinusitis with nasal polyposis, and a convincing clinical history of NSAID sensitivity
- All subjects must have a SNOT 22 score ≥ 19 despite standard medical therapy. This minimal SNOT 22 was calculated by taking the range of SNOT 22 scores in studies of normal controls plus 8.9, which is the minimal clinically meaningful improvement in SNOT 22 score detected by patients.
- Able to understand and willingness to sign informed consent
- Able to comply with study procedures
Key exclusion criteria (8 listed)
- Patient < 18 years of age
- Pregnancy or breast feeding
- Current tobacco use
- Significant, uncontrolled medical conditions
- Ongoing malignancy or history of malignancy in remission within the past 12 months
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 |
|---|---|---|
| DupilumabAlso: Matching placebodupilumab 300 mg subcutaneous injection every 2 weeks | Drug | Treatment arm |
Primary outcome
SNOT 22 Score
Time frame: From baseline to completion of study(7 months total)
This is a patient-reported outcome score for chronic rhinosinusitis with or without nasal polyposis
14 secondary outcomes
UPSIT
Time frame: From baseline to completion of study( 7 months total)
Lund Mackay score
Time frame: From baseline to completion of study( 7 months total)
ACT score
Time frame: From baseline to completion of study( 7 months total)
Asthma Mini-AQLQ, 15 questions to assess quality of life. This assessment takes approximately 4-5 minutes to complete the questions.
Time frame: From baseline to completion of study( 7 months total)
Change in FEV1
Time frame: From baseline to completion of study( 7 months total)
Change in FeNO
Time frame: From baseline to completion of study( 7 months total)
Eosinophil count
Time frame: From baseline to completion of study( 7 months total)
Total serum IgE
Time frame: From baseline to completion of study( 7 months total)
Serum tryptase
Time frame: From baseline to completion of study( 7 months total)
Serum TARC (thymus and activation regulated cytokine)
Time frame: From baseline to completion of study( 7 months total)
Serum prostaglandin D2
Time frame: From baseline to completion of study( 7 months total)
24 hour urinary leukotriene E4
Time frame: From baseline to completion of study( 7 months total)
To assess the safety and tolerability of dupilumab
Time frame: From baseline to completion of study( 7 months total)
To assess cumulative dose of systemic steroids
Time frame: From baseline to completion of study( 7 months total)
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 26 Aug 2020.
- Background: PubMed 25282015Rajan JP, Wineinger NE, Stevenson DD, White AA. Prevalence of aspirin-exacerbated respiratory disease among asthmatic patients: A meta-analysis of the literature. J Allergy Clin Immunol. 2015 Mar;135(3):676-81.e1. doi: 10.1016/j.jaci.2014.08.020. Epub 2014 Oct 3.
- Background: PubMed 23639706Mullol J, Picado C. Rhinosinusitis and nasal polyps in aspirin-exacerbated respiratory disease. Immunol Allergy Clin North Am. 2013 May;33(2):163-76. doi: 10.1016/j.iac.2012.11.002. Epub 2012 Dec 23.
- Background: PubMed 25858054Ta V, White AA. Survey-Defined Patient Experiences With Aspirin-Exacerbated Respiratory Disease. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):711-8. doi: 10.1016/j.jaip.2015.03.001. Epub 2015 Apr 7.
- Background: PubMed 12532116Berges-Gimeno MP, Simon RA, Stevenson DD. Long-term treatment with aspirin desensitization in asthmatic patients with aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2003 Jan;111(1):180-6. doi: 10.1067/mai.2003.7.
- Background: PubMed 6368649Stevenson DD, Pleskow WW, Simon RA, Mathison DA, Lumry WR, Schatz M, Zeiger RS. Aspirin-sensitive rhinosinusitis asthma: a double-blind crossover study of treatment with aspirin. J Allergy Clin Immunol. 1984 Apr;73(4):500-7. doi: 10.1016/0091-6749(84)90361-0.
- Background: PubMed 24767875Swierczynska-Krepa M, Sanak M, Bochenek G, Strek P, Cmiel A, Gielicz A, Plutecka H, Szczeklik A, Nizankowska-Mogilnicka E. Aspirin desensitization in patients with aspirin-induced and aspirin-tolerant asthma: a double-blind study. J Allergy Clin Immunol. 2014 Oct;134(4):883-90. doi: 10.1016/j.jaci.2014.02.041. Epub 2014 Apr 24.
- Background: PubMed 23464577Fruth K, Pogorzelski B, Schmidtmann I, Springer J, Fennan N, Fraessdorf N, Boessert A, Schaefer D, Gosepath J, Mann WJ. Low-dose aspirin desensitization in individuals with aspirin-exacerbated respiratory disease. Allergy. 2013;68(5):659-65. doi: 10.1111/all.12131. Epub 2013 Mar 7.
- Background: PubMed 26083948Esmaeilzadeh H, Nabavi M, Aryan Z, Arshi S, Bemanian MH, Fallahpour M, Mortazavi N. Aspirin desensitization for patients with aspirin-exacerbated respiratory disease: A randomized double-blind placebo-controlled trial. Clin Immunol. 2015 Oct;160(2):349-57. doi: 10.1016/j.clim.2015.05.012. Epub 2015 Jun 14.
- Background: PubMed 27452889Waldram JD, White AA. A survey of aspirin desensitization practices among allergists and fellows in training in the United States. J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1253-1255. doi: 10.1016/j.jaip.2016.06.016. Epub 2016 Jul 21. No abstract available.
- Background: PubMed 2820055Samuelsson B, Dahlen SE, Lindgren JA, Rouzer CA, Serhan CN. Leukotrienes and lipoxins: structures, biosynthesis, and biological effects. Science. 1987 Sep 4;237(4819):1171-6. doi: 10.1126/science.2820055.
- Background: PubMed 26840139Laidlaw TM, Boyce JA. Aspirin-Exacerbated Respiratory Disease--New Prime Suspects. N Engl J Med. 2016 Feb 4;374(5):484-8. doi: 10.1056/NEJMcibr1514013. No abstract available.
- Background: PubMed 22640264Bachert C, Zhang N. Chronic rhinosinusitis and asthma: novel understanding of the role of IgE 'above atopy'. J Intern Med. 2012 Aug;272(2):133-43. doi: 10.1111/j.1365-2796.2012.02559.x.
- Individual participant dataSharing planned: No
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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.
S Shahzad Mustafa, MD principal investigator
Lead Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab in people with Aspirin-exacerbated Respiratory Disease, run by Rochester General Hospital 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 4 inclusion and 8 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 26 Aug 2020. 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. 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?
SNOT 22 Score (time frame: From baseline to completion of study(7 months total)). 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 NCT03595488, which also lists 27 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 26 Aug 2020.