Chronic Rhinosinusitis With Nasal PolypsPhase 2/3NCT05931744
The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis
A Phase 2/3 study testing Budesonide, Prednisone and Saline in people with Chronic Rhinosinusitis With Nasal Polyps, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Budesonide, Prednisone and Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Feb 2023
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients with type 2 CRSwNP -
- elevated serum IgE \& high absolute eosinophilia
- with any grade of nasal polyps
- ages between 18 and 60 years old
- patients who didn't have any contraindications of systemic steroids
Who cannot join
- All patients with previous nasal surgeries
- All patients with cystic fibrosis, ciliary dyskinesia, antrochoanal polyp, fungal sinusitis, unilateral nasal polyps, nasal tumors,
- patients who took systemic steroids in the last 6 months before our study
- patients with any previous nasal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis . A Randomized Clinical Trial
To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps
Read the detailed description
this is a randomized controlled clinical trial where 3 groups with nasal polyps will be treated medically, Group A with oral corticosteroids, Group B with budesonide intrapolyp injection, Group C with placebo saline intrapolyp injection
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Budesonide, Prednisone, Saline
- Keywords
- CRSwNP, Intranasal steroid injection, Budesonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
after application of topical vasoconstrictor packs into both nasal cavities, using 1 cc 28 gauge needle sterile syringe, one pack of budesonide ampule 0.5 mg/2ml was injected into visible polyps on both cavities 1 ml in each cavity weekly for 5 consecutive weeks
PrednisoneDrug
patients given oral prednisone 1 mg/ kg with max. dose 70 mg/d divided into two doses for 3 days then tapered gradually for two weeks
SalineDrug
saline intrapolyp injection
| Study group | Role | What they receive |
|---|---|---|
| Oral steroid | Active comparator | patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks Receives: Drug: Prednisone |
| Budesonide Intrapolyp injection | Experimental | patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks Receives: Drug: Budesonide |
| Saline intrapolyp injection | Placebo comparator | patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sino-Nasal Outcome Test "SNOT-22" Score
subjective method to assess the patient's quality of life "QOL" and the severity of the disease before and after treatment, The lower the score, The better the condition
Measured: 6 months
CT Lund Mackay
the radiological evaluation of patients with nasal polyps where each sinus was solitarily assigned a score from (0 to 2), where the Osteomeatal Complex was given only (0 or 2), each side was evaluated on its own and the sum of all sinuses was calculated. A combined score of 24 was the maximum. Investigators asked the patients for a CT scan before starting the treatment and 3 months after the completion of each treatment protocol
Measured: 6 months
Total nasal Polyp score "TNPS"
the clinical assessment of nasal polyps, the total nasal polyp score "TNPS" was used where polyp size was evaluated through endoscopy and given a score from (0 to 3). TNPS was calculated as the sum of the score on each side, and patients were assessed on regular visits before receiving treatment, 1 week after treatment, and after 3 months
Measured: 6 months
Serum IgE
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 May 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim M. Gehad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931744
- Sponsor's protocol ID
- MKSU 50-7-8
- Status last verified
- Jul 2023
- First submitted
- 12 May 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis . A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05931744
- Acronym / sponsor ID
- MKSU 50-7-8
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- CRSwNP, Intranasal steroid injection, Budesonide
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 5 Jul 2023 (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.
To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps
Detailed description
this is a randomized controlled clinical trial where 3 groups with nasal polyps will be treated medically, Group A with oral corticosteroids, Group B with budesonide intrapolyp injection, Group C with placebo saline intrapolyp injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral steroid | Active comparator | Drug: Prednisonepatients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks |
| Budesonide Intrapolyp injection | Experimental | Drug: Budesonidepatients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks |
| Saline intrapolyp injection | Placebo comparator | Drug: Salinepatients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All patients with type 2 CRSwNP -
- elevated serum IgE \& high absolute eosinophilia
- with any grade of nasal polyps
- ages between 18 and 60 years old
- patients who didn't have any contraindications of systemic steroids
Key exclusion criteria (4 listed)
- All patients with previous nasal surgeries
- All patients with cystic fibrosis, ciliary dyskinesia, antrochoanal polyp, fungal sinusitis, unilateral nasal polyps, nasal tumors,
- patients who took systemic steroids in the last 6 months before our study
- patients with any previous nasal surgery
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 |
|---|---|---|
| Budesonideafter application of topical vasoconstrictor packs into both nasal cavities, using 1 cc 28 gauge needle sterile syringe, one pack of budesonide ampule 0.5 mg/2ml was injected into visible polyps on both cavities 1 ml in each cavity weekly for 5 consecutive weeks | Drug | Budesonide Intrapolyp injection |
| Prednisonepatients given oral prednisone 1 mg/ kg with max. dose 70 mg/d divided into two doses for 3 days then tapered gradually for two weeks | Drug | Oral steroid |
| Salinesaline intrapolyp injection | Drug | Saline intrapolyp injection |
Primary outcome
Sino-Nasal Outcome Test "SNOT-22" Score
Time frame: 6 months
subjective method to assess the patient's quality of life "QOL" and the severity of the disease before and after treatment, The lower the score, The better the condition
CT Lund Mackay
Time frame: 6 months
the radiological evaluation of patients with nasal polyps where each sinus was solitarily assigned a score from (0 to 2), where the Osteomeatal Complex was given only (0 or 2), each side was evaluated on its own and the sum of all sinuses was calculated. A combined score of 24 was the maximum. Investigators asked the patients for a CT scan before starting the treatment and 3 months after the completion of each treatment protocol
Total nasal Polyp score "TNPS"
Time frame: 6 months
the clinical assessment of nasal polyps, the total nasal polyp score "TNPS" was used where polyp size was evaluated through endoscopy and given a score from (0 to 3). TNPS was calculated as the sum of the score on each side, and patients were assessed on regular visits before receiving treatment, 1 week after treatment, and after 3 months
Serum IgE
Time frame: 1 month
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 5 Jul 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Budesonide, Prednisone and Saline in people with Chronic Rhinosinusitis With Nasal Polyps, run by Kafrelsheikh University at 1 site in Egypt.
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 5 inclusion and 4 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 5 Jul 2023. 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 Egypt. 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 combined 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.
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?
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?
Sino-Nasal Outcome Test "SNOT-22" Score (time frame: 6 months). The study lists 4 primary outcomes in all. 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 5 Jul 2023.