SinusitisPhase 3NCT02799446
Effect of Reslizumab in Chronic Rhinosinusitis
A Phase 3 study testing Reslizumab in people with Sinusitis, run by Joshua S. Jacobs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- Reslizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jul 2019
- Phase
- Phase 3
- 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
- Written informed consent
- Willingness and ability to comply with the requirements of the study
- Female or male patients ages 18-75 at the time of screening
- A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
- Elevated blood eosinophils
- Significant findings on computed tomography (CT) scan
Who cannot join
- Unable to sign informed consent form
- A woman that is pregnant or nursing a child
- Known hypersensitivity to Reslizumab
- Active cigarette smoking in the year prior to screening
- Known underlying immunodeficiency
- History of alcohol or drug abuse in the year prior to screening
- Other criteria may apply. Please contact the investigator for more information
Trial locations and contacts
1 site in 1 country.
Study Coordinator contact
United States1 site, 1 recruiting
- Recruiting
Allergy and Asthma Clinical Research
Walnut Creek, California, 94598
925-935-2599
About this study
Official title: Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial
The purpose of this study is to determine whether Reslizumab is effective for the treatment of chronic sinusitis.
- Conditions
- Sinusitis
- Being tested
- Reslizumab, Placebo
- Keywords
- sinusitis, rhinitis, rhinosinusitis, chronic
- Medical subject headings
- Sinusitis, Rhinitis, Rhinosinusitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReslizumabDrug
Reslizumab 3mg/kg intravenous (IV)
PlaceboDrug
Matching Placebo intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Reslizumab | Experimental | Reslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg. Receives: Drug: Reslizumab |
| Placebo | Placebo comparator | Matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in computed tomography (CT) score
Measured: 24 weeks
Secondary outcomes (4)
Quality of life questionnaire
Measured: 24 weeks
Smell test
Measured: 24 weeks
Endoscopy score
Measured: 24 weeks
Adverse events by body system
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joshua S. Jacobs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua S. Jacobs, Allergy and Asthma Clinical Research Inc.
- Investigators
- Joshua Jacobs, MD, Principal investigator, Allergy and Asthma Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799446
- Sponsor's protocol ID
- AACR-01
- Status last verified
- Jan 2018
- First submitted
- 10 Jun 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial
- ClinicalTrials.gov ID
- NCT02799446
- Acronym / sponsor ID
- AACR-01
- Conditions
- Sinusitis
- Keywords
- sinusitis, rhinitis, rhinosinusitis, chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Joshua S. JacobsUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 14 Jun 2016 (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 whether Reslizumab is effective for the treatment of chronic sinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reslizumab | Experimental | Drug: ReslizumabReslizumab will be administered intravenously every 4 weeks at a dose of 3mg/kg. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- Willingness and ability to comply with the requirements of the study
- Female or male patients ages 18-75 at the time of screening
- A diagnosis of chronic rhinosinusitis according to the clinical practice guideline (update) of the American academy of otolaryngology - head and neck surgery
- Elevated blood eosinophils
Key exclusion criteria (7 listed)
- Unable to sign informed consent form
- A woman that is pregnant or nursing a child
- Known hypersensitivity to Reslizumab
- Active cigarette smoking in the year prior to screening
- Known underlying immunodeficiency
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 |
|---|---|---|
| ReslizumabReslizumab 3mg/kg intravenous (IV) | Drug | Reslizumab |
| PlaceboMatching Placebo intravenous (IV) | Drug | Placebo |
Primary outcome
Change in computed tomography (CT) score
Time frame: 24 weeks
4 secondary outcomes
Quality of life questionnaire
Time frame: 24 weeks
Smell test
Time frame: 24 weeks
Endoscopy score
Time frame: 24 weeks
Adverse events by body system
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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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.
Study Coordinator contact
Joshua Jacobs, MD principal investigator
Allergy and Asthma Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reslizumab in people with Sinusitis, run by Joshua S. Jacobs 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 7 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (925-935-2599), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in computed tomography (CT) score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2018.