Chronic SinusitisPhase 2NCT05369039
Roflumilust in Chronic Rhinosinusitis With Nasal Polyposis.
A Phase 2 study testing Roflumilust and Prednisolone in people with Chronic Sinusitis, run by Menoufia University at 1 site in Egypt.
Trial summary
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Roflumilust and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Mar 2023
- 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
- chronic rhinosinusitis with nasal polyposis,
- No history of systemic steroid administration over the last three months
Who cannot join
- History of previous nasal surgery,
- Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
- Hypersensitivity to Roflumilust
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Menoufia Faculty of Medicine
Shibīn al Kawm, Menoufia, 32511
Ahmad Hamdan, MD, 00201008993175, Ahmed.Hamdan@med.menofia.edu.eg
About this study
Official title: The Potential Therapeutic Effect of Roflumilust (a Selective Phosphodiesterase 4inhibitor) on Chronic Rhinosinusitis With Nasal Polyposis.
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. The patients of this study will be randomly and equally distributed among case and control groups to compare the effect of Roflumilust administration with the effect of systemic and local corticosteroids on patients with chronic rhinosinusitis with nasal polyposis
Read the detailed description
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. The patients of this study will be randomly and equally distributed among case and control groups.
To be included in the study, patients should be more than 18 years old, have chronic rhinosinusitis with nasal polyposis, and have no history of systemic steroid administration over the last three months. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Roflumilust were the exclusion criteria for this study.
Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily. The Control group will receive a 10 days course of systemic steroids in the form of oral prednisolone in a dose of 40 mg per day.
Assessment protocol:
Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria and to assess the burden of nasal symptoms using SNOT-22 scale. Endoscopic examination of the nasal cavity will be performed to confirm the presence of bilateral nasal polyposis and to assess the degree of nasal polyposis using the Lund Kennedy score. Serum IL17 and periostin will be assessed using ELISA technique before and after treatment to assess the anti-inflammatory effects of the drug.
Outcome measures:
Primary outcome measures will include a comparison between the pre and post treatment values of SNOT-22 and Lund Kennedy scores, serum IL17, and serum priostin in both case and control groups. Another outcome measure will be the comparison between the case and control groups regarding the posttreatment and posttreatment values of the previous indices. Secondary outcome measures will include an assessment of the side effects of Roflumilust among the case group.
- Conditions
- Chronic Sinusitis
- Being tested
- Roflumilust, Prednisolone
- Keywords
- Roflumilust, Chronic Sinusitis with nasal polyposis, Phosphodiesterase inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilustDrug
A selective phosphodiesterase 4 Inhibitor
PrednisoloneDrug
Systemic corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Experimental | The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily. Receives: Drug: Roflumilust |
| Control group | Active comparator | The Control group will receive a 10 days course of systemic steroids in the form of oral prednisolone in a dose of 40 mg per day. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between pretreatment and posttreatment SNOT-22 score in both groups
Post-treatment SNOT-22 scores will be compared with pretreatment scores in both groups
Measured: 2 weeks after start of treatment
Comparison between pretreatment and posttreatment Lund Kennedy scores in both groups
Post-treatment Lund Kennedy scores will be compared with pretreatment scores in both groups
Measured: Two weeks after start of treatment
Comparison between pretreatment and posttreatment Serum periostin levels in both groups
Post-treatment Serum periostin level in pg/ml will be compared with pretreatment levels in both group
Measured: Two weeks after start of treatment
Comparison between case and control groups regarding SNOT 22 score
Case and control groups are compared regarding post-treatment SNOT-22 score
Measured: Two weeks after start of treatment
Comparison between case and control groups regarding Lund Kennedy score
Case and control groups are compared regarding post-treatment Lund Kennedy score
Measured: Two weeks after start of treatment
Comparison between case and control groups regarding serum periostin level
Case and control groups are compared regarding post-treatment serum periostin level in pg/ml
Measured: Two weeks after start of treatment
Secondary outcomes (1)
Assessment of the side effects of Roflumilust
The side effects of Roflumilust will be assessed among the case group
Measured: Two weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study startJun 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mahmoud Hamdan, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369039
- Sponsor's protocol ID
- 1/2022 ENT
- Status last verified
- May 2022
- First submitted
- 3 Mar 2022
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available on request from the authors
Publications
Hulse KE, Stevens WW, Tan BK, Schleimer RP. Pathogenesis of nasal polyposis. Clin Exp Allergy. 2015 Feb;45(2):328-46. doi: 10.1111/cea.12472.
PubMed 25482020Ryu G, Bae JS, Kim JH, Kim EH, Lyu L, Chung YJ, Mo JH. Role of IL-17A in Chronic Rhinosinusitis With Nasal Polyp. Allergy Asthma Immunol Res. 2020 May;12(3):507-522. doi: 10.4168/aair.2020.12.3.507.
PubMed 32141263Maxfield AZ, Landegger LD, Brook CD, Lehmann AE, Campbell AP, Bergmark RW, Stankovic KM, Metson R. Periostin as a Biomarker for Nasal Polyps in Chronic Rhinosinusitis. Otolaryngol Head Neck Surg. 2018 Jan;158(1):181-186. doi: 10.1177/0194599817737967. Epub 2017 Oct 17.
PubMed 29040053Janosova V, Calkovsky V, Pedan H, Behanova E, Hajtman A, Calkovska A. Phosphodiesterase 4 Inhibitors in Allergic Rhinitis/Rhinosinusitis. Front Pharmacol. 2020 Jul 22;11:1135. doi: 10.3389/fphar.2020.01135. eCollection 2020.
PubMed 32792957Inagaki N, Miura T, Daikoku M, Nagai H, Koda A. Inhibitory effects of beta-adrenergic stimulants on increased vascular permeability caused by passive cutaneous anaphylaxis, allergic mediators, and mediator releasers in rats. Pharmacology. 1989;39(1):19-27. doi: 10.1159/000138567.
PubMed 2479953
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Therapeutic Effect of Roflumilust (a Selective Phosphodiesterase 4inhibitor) on Chronic Rhinosinusitis With Nasal Polyposis.
- ClinicalTrials.gov ID
- NCT05369039
- Acronym / sponsor ID
- 1/2022 ENT
- Conditions
- Chronic Sinusitis
- Keywords
- Roflumilust, Chronic Sinusitis with nasal polyposis, Phosphodiesterase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 11 May 2022 (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.
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. The patients of this study will be randomly and equally distributed among case and control groups to compare the effect of Roflumilust administration with the effect of systemic and local corticosteroids on patients with chronic rhinosinusitis with nasal polyposis
Detailed description
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. The patients of this study will be randomly and equally distributed among case and control groups.
To be included in the study, patients should be more than 18 years old, have chronic rhinosinusitis with nasal polyposis, and have no history of systemic steroid administration over the last three months. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Roflumilust were the exclusion criteria for this study.
Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily. The Control group will receive a 10 days course of systemic steroids in the form of oral prednisolone in a dose of 40 mg per day.
Assessment protocol:
Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria and to assess the burden of nasal symptoms using SNOT-22 scale. Endoscopic examination of the nasal cavity will be performed to confirm the presence of bilateral nasal polyposis and to assess the degree of nasal polyposis using the Lund Kennedy score. Serum IL17 and periostin will be assessed using ELISA technique before and after treatment to assess the anti-inflammatory effects of the drug.
Outcome measures:
Primary outcome measures will include a comparison between the pre and post treatment values of SNOT-22 and Lund Kennedy scores, serum IL17, and serum priostin in both case and control groups. Another outcome measure will be the comparison between the case and control groups regarding the posttreatment and posttreatment values of the previous indices. Secondary outcome measures will include an assessment of the side effects of Roflumilust among the case group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | Experimental | Drug: RoflumilustThe case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily. |
| Control group | Active comparator | Drug: PrednisoloneThe Control group will receive a 10 days course of systemic steroids in the form of oral prednisolone in a dose of 40 mg per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic rhinosinusitis with nasal polyposis,
- No history of systemic steroid administration over the last three months
Key exclusion criteria (3 listed)
- History of previous nasal surgery,
- Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
- Hypersensitivity to Roflumilust
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 |
|---|---|---|
| RoflumilustA selective phosphodiesterase 4 Inhibitor | Drug | Case Group |
| PrednisoloneSystemic corticosteroid | Drug | Control group |
Primary outcome
Comparison between pretreatment and posttreatment SNOT-22 score in both groups
Time frame: 2 weeks after start of treatment
Post-treatment SNOT-22 scores will be compared with pretreatment scores in both groups
Comparison between pretreatment and posttreatment Lund Kennedy scores in both groups
Time frame: Two weeks after start of treatment
Post-treatment Lund Kennedy scores will be compared with pretreatment scores in both groups
Comparison between pretreatment and posttreatment Serum periostin levels in both groups
Time frame: Two weeks after start of treatment
Post-treatment Serum periostin level in pg/ml will be compared with pretreatment levels in both group
Comparison between case and control groups regarding SNOT 22 score
Time frame: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment SNOT-22 score
Comparison between case and control groups regarding Lund Kennedy score
Time frame: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment Lund Kennedy score
Comparison between case and control groups regarding serum periostin level
Time frame: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment serum periostin level in pg/ml
1 secondary outcome
Assessment of the side effects of Roflumilust
Time frame: Two weeks after start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Background: PubMed 25482020Hulse KE, Stevens WW, Tan BK, Schleimer RP. Pathogenesis of nasal polyposis. Clin Exp Allergy. 2015 Feb;45(2):328-46. doi: 10.1111/cea.12472.
- Background: PubMed 32141263Ryu G, Bae JS, Kim JH, Kim EH, Lyu L, Chung YJ, Mo JH. Role of IL-17A in Chronic Rhinosinusitis With Nasal Polyp. Allergy Asthma Immunol Res. 2020 May;12(3):507-522. doi: 10.4168/aair.2020.12.3.507.
- Background: PubMed 29040053Maxfield AZ, Landegger LD, Brook CD, Lehmann AE, Campbell AP, Bergmark RW, Stankovic KM, Metson R. Periostin as a Biomarker for Nasal Polyps in Chronic Rhinosinusitis. Otolaryngol Head Neck Surg. 2018 Jan;158(1):181-186. doi: 10.1177/0194599817737967. Epub 2017 Oct 17.
- Background: PubMed 32792957Janosova V, Calkovsky V, Pedan H, Behanova E, Hajtman A, Calkovska A. Phosphodiesterase 4 Inhibitors in Allergic Rhinitis/Rhinosinusitis. Front Pharmacol. 2020 Jul 22;11:1135. doi: 10.3389/fphar.2020.01135. eCollection 2020.
- Background: PubMed 2479953Inagaki N, Miura T, Daikoku M, Nagai H, Koda A. Inhibitory effects of beta-adrenergic stimulants on increased vascular permeability caused by passive cutaneous anaphylaxis, allergic mediators, and mediator releasers in rats. Pharmacology. 1989;39(1):19-27. doi: 10.1159/000138567.
- Individual participant dataSharing planned: Yes. Data is available on request from the authors
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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.
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 Roflumilust and Prednisolone in people with Chronic Sinusitis, run by Menoufia 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 2 inclusion and 3 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 11 May 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmad M Hamdan, MD (00201008993175, Ahmed.Hamdan@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between pretreatment and posttreatment SNOT-22 score in both groups (time frame: 2 weeks after start of treatment). The study lists 6 primary outcomes in all. 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 NCT05369039, which also lists 5 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 11 May 2022.