Chronic Rhinosinustis With PolypsPhase 3NCT02665806
Ciclesonide vs Fluticasone Nasal Sprays in Nasal Poplyposis
A Phase 3 study testing Ciclesonide and Fluticasone in people with Chronic Rhinosinustis With Polyps, run by Tehran University of Medical Sciences.
Trial summary
This study is designed to compare ciclesonide nasal spray once daily with fluticasone propionate aquas nasal spray BD, which is commonly prescribed in patients with nasal polyposis, in order to relieve symptoms of these patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Rhinosinustis With Polyps
- What is being tested?
- Ciclesonide and Fluticasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals with the diagnosis of symptomatic nasal polyposis included.
- Objective confirmation of chronic rhinosinusitis with polyps was done by paranasal sinuses CT scan and Endoscopy.
Who cannot join
- Administration of systemic corticosteroids during last 3 months Administration of antihistamines, nasal steroids 15 days prior the including to the study.
- History of surgical treatment during last 3 month.
- History of septal deviation, severe epistaxis, cystic fibrosis, severe or non-controlled asthma, current purulent nasal infection, allergic rhinitis.
- Hypersensitivity or contraindication to steroids.
- Any positive history that was suspected to influence study parameters.
- NP requiring systemic corticosteroids or daily use of saline irrigations.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ciclesonide vs Fluticasone Propionate Nasal Sprays in Patients With Nasal Poplyposis; a Randomized Clinical Trial
This study is designed to compare ciclesonide nasal spray once daily with fluticasone propionate aquas nasal spray BD, which is commonly prescribed in patients with nasal polyposis, in order to relieve symptoms of these patients.
Read the detailed description
The study will be conducted in a tertiary ENT center in Tehran. Endoscopic severity grades for patients will be determined for polyps on the basis of 3 point classification system: 1, confined to middle meatus; 2, below level of middle turbinate; 3, causing total obstruction. Also, patients will be undergone paranasal sinus CT scan to determine Lund-Mackay stage which defined by sum of scores of each of 12 paranasal sinuses (0 for a completely lucent, 1 for a partially opaque and 2 for a completely opaque sinus). Patients will be randomized to treat in one of two groups: 1 month of therapy with fluticasone propionate aqueous nasal spray (FPANS) 200 µg twice a day or 1 month of therapy with intranasal ciclesonide spray 200 µg once daily. All patients will be given written, easy to understand instruction about how to use nasal sprays. All included patients are asked to answer the disease specific Persian language validated SNOT20 quality of life questionnaire to evaluate symptom severity before starting the treatment. SNOT20 is a symptom severity and health related quality of life measure in sinonasal diseases that contains 20 questions about CRS related symptoms. Symptoms severity is scored 0, indicating no problem to 5, indicating worst possible symptom. Then scores of each of 20 items will be added to produce a total score ranging from 0 to 100. After one month of treatment patients will be visited by a blind physician to assess the symptoms. Then patients will answer the SNOT20 questionnaire again. Patients will be given a chance to report any problem during drug administration and enquired about adverse effects at the end of 1 month of treatment by the physician. Withdrawals is defined as any drug or study discontinuation due to adverse effects or lack of efficacy.
By considering 5% level of significance, to have 90% power to detect a clinically important difference of 0.6 points between two groups in improving total score of SNOT20 assuming a standard deviation (SD) of 0.6, we should include 22 cases in each study arm. To address a 10% probable loss to follow up, we would recruit 24 cases in each arm.
The continuous variables will be shown as mean ± SD. The categorical variables will be presented as frequency and percentage. The normality of measure outcome variables will be tested graphically as well as statistically with the Shapiro-Wilk test. In case of normal distribution we would use parametric t-test to compare the mean values between two groups. Otherwise we would use non-parametric Mann-Whitney test. Chi-squared or Fischer-exact tests will be used to compare categorical variables. All the statistical analyses will be conducted using IBM SPSS statistics for Windows, version 23.0, (Armonk, NY: IBM Corp.).
- Conditions
- Chronic Rhinosinustis With Polyps
- Being tested
- Ciclesonide, Fluticasone
- Keywords
- Ciclesonide, Fluticasone propionate, Nasal Polyposis, Chronic Sinuitis, Chronic rhinosinusitis
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclesonideDrug
intranasal ciclesonide spray 200 µg once daily
FluticasoneDrug
fluticasone propionate aqueous nasal spray 200 µg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Ciclesonide | Experimental | Not described Receives: Drug: Ciclesonide |
| Fluticasone | Active comparator | Not described Receives: Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT20 score difference
The change from the baseline in SNOT20 total score after the treatment period
Measured: 1 Month
Secondary outcomes (2)
SNOT20 score difference in variuos endoscopic grades
The change from the baseline in SNOT20 total score after the treatment period in patients with various endoscopic grades
Measured: 1 Month
SNOT20 score difference in variuos Lund-Mackay score
The change from the baseline in SNOT20 total score after the treatment period in patients with various paranasanl sinus CT Scan's Lund-Mackay scores
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 posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinustis With PolypsStudies 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Naraghi, Tehran University of Medical Sciences
- Investigators
- Mohsen Naraghi, MD, Principal investigator, Tehran University of Medical Sciences, Department of Otolaryngology-Head and Neck Surgery, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665806
- Sponsor's protocol ID
- IR.TUMS.REC.1394.1586
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciclesonide vs Fluticasone Propionate Nasal Sprays in Patients With Nasal Poplyposis; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02665806
- Acronym / sponsor ID
- IR.TUMS.REC.1394.1586
- Conditions
- Chronic Rhinosinustis With Polyps
- Keywords
- Ciclesonide, Fluticasone propionate, Nasal Polyposis, Chronic Sinuitis, Chronic rhinosinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 28 Jan 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.
This study is designed to compare ciclesonide nasal spray once daily with fluticasone propionate aquas nasal spray BD, which is commonly prescribed in patients with nasal polyposis, in order to relieve symptoms of these patients.
Detailed description
The study will be conducted in a tertiary ENT center in Tehran. Endoscopic severity grades for patients will be determined for polyps on the basis of 3 point classification system: 1, confined to middle meatus; 2, below level of middle turbinate; 3, causing total obstruction. Also, patients will be undergone paranasal sinus CT scan to determine Lund-Mackay stage which defined by sum of scores of each of 12 paranasal sinuses (0 for a completely lucent, 1 for a partially opaque and 2 for a completely opaque sinus). Patients will be randomized to treat in one of two groups: 1 month of therapy with fluticasone propionate aqueous nasal spray (FPANS) 200 µg twice a day or 1 month of therapy with intranasal ciclesonide spray 200 µg once daily. All patients will be given written, easy to understand instruction about how to use nasal sprays. All included patients are asked to answer the disease specific Persian language validated SNOT20 quality of life questionnaire to evaluate symptom severity before starting the treatment. SNOT20 is a symptom severity and health related quality of life measure in sinonasal diseases that contains 20 questions about CRS related symptoms. Symptoms severity is scored 0, indicating no problem to 5, indicating worst possible symptom. Then scores of each of 20 items will be added to produce a total score ranging from 0 to 100. After one month of treatment patients will be visited by a blind physician to assess the symptoms. Then patients will answer the SNOT20 questionnaire again. Patients will be given a chance to report any problem during drug administration and enquired about adverse effects at the end of 1 month of treatment by the physician. Withdrawals is defined as any drug or study discontinuation due to adverse effects or lack of efficacy.
By considering 5% level of significance, to have 90% power to detect a clinically important difference of 0.6 points between two groups in improving total score of SNOT20 assuming a standard deviation (SD) of 0.6, we should include 22 cases in each study arm. To address a 10% probable loss to follow up, we would recruit 24 cases in each arm.
The continuous variables will be shown as mean ± SD. The categorical variables will be presented as frequency and percentage. The normality of measure outcome variables will be tested graphically as well as statistically with the Shapiro-Wilk test. In case of normal distribution we would use parametric t-test to compare the mean values between two groups. Otherwise we would use non-parametric Mann-Whitney test. Chi-squared or Fischer-exact tests will be used to compare categorical variables. All the statistical analyses will be conducted using IBM SPSS statistics for Windows, version 23.0, (Armonk, NY: IBM Corp.).
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 |
|---|---|---|
| Ciclesonide | Experimental | Drug: Ciclesonide |
| Fluticasone | Active comparator | Drug: Fluticasone |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with the diagnosis of symptomatic nasal polyposis included.
- Objective confirmation of chronic rhinosinusitis with polyps was done by paranasal sinuses CT scan and Endoscopy.
Key exclusion criteria (6 listed)
- Administration of systemic corticosteroids during last 3 months Administration of antihistamines, nasal steroids 15 days prior the including to the study.
- History of surgical treatment during last 3 month.
- History of septal deviation, severe epistaxis, cystic fibrosis, severe or non-controlled asthma, current purulent nasal infection, allergic rhinitis.
- Hypersensitivity or contraindication to steroids.
- Any positive history that was suspected to influence study parameters.
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 |
|---|---|---|
| Ciclesonideintranasal ciclesonide spray 200 µg once daily | Drug | Ciclesonide |
| Fluticasonefluticasone propionate aqueous nasal spray 200 µg twice a day | Drug | Fluticasone |
Primary outcome
SNOT20 score difference
Time frame: 1 Month
The change from the baseline in SNOT20 total score after the treatment period
2 secondary outcomes
SNOT20 score difference in variuos endoscopic grades
Time frame: 1 Month
SNOT20 score difference in variuos Lund-Mackay score
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Individual participant dataSharing planned: No
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.
Mohsen Naraghi, MD principal investigator
Tehran University of Medical Sciences, Department of Otolaryngology-Head and Neck Surgery, Tehran, Iran
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciclesonide and Fluticasone in people with Chronic Rhinosinustis With Polyps, run by Tehran University of Medical Sciences.
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 6 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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 Salar Tofighi, MD (+989124109390, dr.salar.tofighi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNOT20 score difference (time frame: 1 Month). 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 28 Jan 2016.