Chronic Rhinosinusitis (Diagnosis)CRSNCT05541419
Use of Budesonide Diluted to Maximum Clinical Treatment of Patients With Chronic Rhinosinusitis With Polyoposis.
A study testing Budesonide Nasal in people with Chronic Rhinosinusitis (Diagnosis), run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
This is a double-blind, randomized, double-blind, randomized, double-blind, randomized block design with two intervention groups of 30 patients each. Patients not recruited at the otorhinolaryngology outpatient clinic of the Regional University Hospital of the North of Paraná and the University Hospital Specialties… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Budesonide Nasal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Aug 2018to 10 Aug 2025
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A minimum nasal polyp score (NPS) of 5 of a maximum of 8 for both nostrils (with at least a score of 2 for each nostril).
- Presence of at least two of the following symptoms prior to screening: nasal blockage / obstruction / congestion or rhinorrhea (anterior or posterior); facial / pressure pain; reduction or loss of smell.
Who cannot join
- A patient under the age of 18, or over 55;
- SNOT-22 with sum of less than 7;
- Patients who have used drugs or therapies that interfere with the results of this clinical trial within 2 months prior to screening: treatment with immunosuppressants; anti-immunoglobulin and within two months prior to screening.
- Initiation of allergen immunotherapy within 3 months prior to first consultation or plan to initiate therapy during the screening period or randomized treatment period;
- Patients who underwent any nasal surgery;
- Patients on anti-leukotrienes and antihistamines
- Asthmatic patients will be excluded if: forced expiratory volume (FEV1) is 60% predicted or lower; an exacerbation requiring systemic (oral and / or parenteral) or hospitalization for more than 24 hours for the treatment of asthma has occurred within 3 months prior to screening; use of a dose greater than 1000 μg of inhaled fluticasone or equivalent;
- Patients with a short life expectancy (less than 6 months);
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Marco Aurelio Fornazieri
Londrina, Paraná, 86010-160
Marco A Fornazieri, 4330291436, marcofornazieri@gmail.com
About this study
Official title: Efficacy of Addition of High-volume Nasal Wash With Budesonide Diluted to Maximum Clinical Treatment of Patients With Chronic Rhinosinusitis With Polyoposis: Double, Randomized, Controlled Double Study
This is a double-blind, randomized, double-blind, randomized, double-blind, randomized block design with two intervention groups of 30 patients each. Patients not recruited at the otorhinolaryngology outpatient clinic of the Regional University Hospital of the North of Paraná and the University Hospital Specialties Ambulatory will be included in the study of chronic rhinosinusitis with polyposis are randomly divided with stratification for the presence of two groups of patients. 30 patients, with 9 asthmatics in each). Of the nasal nasal with 2mg budesonide diluted in high daily volume added to the corticosteroid injectable injectable and the topic for 16 weeks compared to placebo. The Polyp Score (NPS), Sono-Nasal Outcome Test-22 (SNOT-22), University of Pennsylvania Olfactory Identification Test (UPSIT), peak nasal inspiratory flow (PNIF), visual scales preoperative tomography, acoustic rhinometry, computerized rhinomanometry and nasal endoscopy before and after the treatments. Position Paper on Nasal Rhinosinusitis and Nasal Polyps 2012; A bilateral nasal pole score is 5 and a maximum of 8 for both nostrils (with less than a score of 2 for each nostril).
Read the detailed description
INTRODUTION: According to the European Position Paper on Rhinosinusitis and Nasal Polyps 2012, chronic rhinosinusitis in adults can be defined as an inflammation of the nasal mucosa and paranasal sinuses lasting 12 weeks or more , associated or not with nasal polyposis. As to the origin of the polyps, these are typically related to the eosinophilic inflammation of the upper airways and result in obstructions in different degrees of the nasal cavities. Maximum clinical treatment - a combination of several classes of drugs to optimize therapy - often proves to be the first choice in the management of this disease. There is, however, no consensus on the composition or duration of maximal clinical treatment, and success rates are extremely variable. If there is no improvement in the condition, surgical treatment is usually instituted and, if necessary, supplemented with topical post-operative treatment. Recent studies have led to the perception that sprays and aerosols can not adequately reach the paranasal sinuses resulting in a better effect of the medication, if possible, such methods should be replaced by nasal cavity lavages using high volume solutions. OBJECTIVES: The present study aims to compare, through validated tests, the impact of the inclusion of nasal lavage with budesonide diluted in high volume in relation to placebo, in the improvement of the symptoms, signs, and quality of life of patients with chronic rhinosinusitis with polyposis. If effective, this therapy may decrease surgical indications and, consequently, health expenditures for the government. METHODOLOGY: Parallel, randomized, placebo-controlled, parallel type clinical trial. Patients with chronic rhinosinusitis with polyposis will be divided randomly with stratification for the presence of asthma in two groups (two blocks of 30 patients, 9 asthmatics each). It will evaluate the effectiveness of nasal lavage with 2mg budesonide diluted in high volume daily added to the initial systemic corticosteroid injectable and the topic for 16 weeks compared to placebo. EXPECTED RESULTS: It is expected that diluted budesonide improvement in the symptoms, signs, and quality of life of patients with chronic rhinosinusitis with polyposis.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Budesonide Nasal, Placebos
- Keywords
- Rhinosinusitis, Quality of life
- Medical subject headings
- Disease, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide NasalDrug
Also called Busonid
The patient performed a lavage once daily with 2mg dilute budesonide. The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril.
PlacebosDrug
Also called placebo effect
Composed of 1% glycerin diluted in water. The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril.
| Study group | Role | What they receive |
|---|---|---|
| Maximum clinical treatment + Budesonide diluted | Experimental | The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril.
In this study, the investigator wishes to add to the maximum clinical treatment a daily wash with high volume diluted budesonide. Receives: Drug: Budesonide Nasal |
| Maximum clinical treatment + Placebo | Placebo comparator | To compare the efficacy of adding diluted budesonide lavage to maximal clinical treatment, the placebo group is used. The placebo formula is composed of 1% glycerin diluted in water. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the improvement in the Nasal Polyp Score
To verify, from the change in the Nasal Polyp Score (NPS, range from 0 to 8, higher score indicates larger polyp size), the impact of maximum clinical treatment - intramuscular injection of Dispropan in intramuscular injectable suspension and budesonide in nasal spray, two sprays of 50 mcg in each nostril - plus high-volume diluted budesonide nasal lavage, compared to the same maximum clinical treatment plus high-flow placebo nasal lavage in patients with chronic rhinosinusitis with polyposis without previous nasal surgery for a period of 16 weeks.
Measured: 16 weeks
Secondary outcomes (3)
Improves olfactory ability through the University of Pennsylvania Smell Identification Test
UNIVERSITY OF PENNSYLVANIA SMELL IDENTIFICATION TEST (UPSIT) - This instrument consists of four cards of 10 odors, with one odor per page. The stimuli are embedded in plastic microcapsules present in a brown band at the bottom of each page. The examiner directs the person being examined to scrape this strip with a pencil, which causes the odor to be released. After that, the patient answers a multiple choice question to describe what the odor looks like. Based on the score obtained, the individual's olfactory function can be classified into normosmia, microsmia (mild, moderate and severe) and anosmia (Fornazieri et al., 2010). This test has been validated for the Brazilian population (Fornazieri et al., 2015).
Measured: 16 weeks
Sino-Nasal Outcome Test - 22 (SNOT-22)
The Sino-Nasal Outcome Test - 22 consists of a questionnaire consisting of 22 questions that assess the severity of nasal symptoms reported by the patient on a scale from 0 to 5 in each question, with a score of 5 being the greatest discomfort to the patient. The questions that make up the SNOT-22 refer to rhinological, otological, facial symptoms (12 questions) and their impact on quality of life (10 questions), which cover sleep function and psychological impairment. The questionnaire, as a whole, includes symptoms such as the need to blow nose, sneezing, rhinorrhea, cough, posterior rhinorrhea, thick rhinorrhea, ear fullness, dizziness, otalgia, facial pain or pressure, difficulty initiating sleep, fatigue on awakening, reduced of productivity and concentration, frustration, sadness and irritability (Piccirillo, Merritt and Richards, 2002; Hopkins et al., 2009).
Measured: 16 weeks
Analogic visual scale (VAS)
The visual analogue scale for chronic rhinosinusitis is used to assess the severity of symptoms and their impact on the patient's quality of life, based on the question: "How problematic are your symptoms of rhinosinusitis?". The patient should mark, on a 10 centimeter line graduated on a scale from zero to ten, the severity of the symptoms reported, with zero representing no discomfort, and ten representing the greatest possible discomfort (Fokkens, Lund and Mullol, 2007) (Bachert et al., 2016).
The disease can be divided into:
Mild = patient scores between 0 and 3; Moderate = patient scores between 3 and 7; Severe = patient scores between 7 and 10.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start10 Aug 2018
- Primary completion25 Aug 2022
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Aurélio Fornazieri, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541419
- Sponsor's protocol ID
- MFornazieri
- Acronym
- CRS
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Addition of High-volume Nasal Wash With Budesonide Diluted to Maximum Clinical Treatment of Patients With Chronic Rhinosinusitis With Polyoposis: Double, Randomized, Controlled Double Study
- ClinicalTrials.gov ID
- NCT05541419
- Acronym / sponsor ID
- CRS / MFornazieri
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Rhinosinusitis, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 15 Sep 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.
This is a double-blind, randomized, double-blind, randomized, double-blind, randomized block design with two intervention groups of 30 patients each. Patients not recruited at the otorhinolaryngology outpatient clinic of the Regional University Hospital of the North of Paraná and the University Hospital Specialties Ambulatory will be included in the study of chronic rhinosinusitis with polyposis are randomly divided with stratification for the presence of two groups of patients. 30 patients, with 9 asthmatics in each). Of the nasal nasal with 2mg budesonide diluted in high daily volume added to the corticosteroid injectable injectable and the topic for 16 weeks compared to placebo. The Polyp Score (NPS), Sono-Nasal Outcome Test-22 (SNOT-22), University of Pennsylvania Olfactory Identification Test (UPSIT), peak nasal inspiratory flow (PNIF), visual scales preoperative tomography, acoustic rhinometry, computerized rhinomanometry and nasal endoscopy before and after the treatments. Position Paper on Nasal Rhinosinusitis and Nasal Polyps 2012; A bilateral nasal pole score is 5 and a maximum of 8 for both nostrils (with less than a score of 2 for each nostril).
Detailed description
INTRODUTION: According to the European Position Paper on Rhinosinusitis and Nasal Polyps 2012, chronic rhinosinusitis in adults can be defined as an inflammation of the nasal mucosa and paranasal sinuses lasting 12 weeks or more , associated or not with nasal polyposis. As to the origin of the polyps, these are typically related to the eosinophilic inflammation of the upper airways and result in obstructions in different degrees of the nasal cavities. Maximum clinical treatment - a combination of several classes of drugs to optimize therapy - often proves to be the first choice in the management of this disease. There is, however, no consensus on the composition or duration of maximal clinical treatment, and success rates are extremely variable. If there is no improvement in the condition, surgical treatment is usually instituted and, if necessary, supplemented with topical post-operative treatment. Recent studies have led to the perception that sprays and aerosols can not adequately reach the paranasal sinuses resulting in a better effect of the medication, if possible, such methods should be replaced by nasal cavity lavages using high volume solutions. OBJECTIVES: The present study aims to compare, through validated tests, the impact of the inclusion of nasal lavage with budesonide diluted in high volume in relation to placebo, in the improvement of the symptoms, signs, and quality of life of patients with chronic rhinosinusitis with polyposis. If effective, this therapy may decrease surgical indications and, consequently, health expenditures for the government. METHODOLOGY: Parallel, randomized, placebo-controlled, parallel type clinical trial. Patients with chronic rhinosinusitis with polyposis will be divided randomly with stratification for the presence of asthma in two groups (two blocks of 30 patients, 9 asthmatics each). It will evaluate the effectiveness of nasal lavage with 2mg budesonide diluted in high volume daily added to the initial systemic corticosteroid injectable and the topic for 16 weeks compared to placebo. EXPECTED RESULTS: It is expected that diluted budesonide improvement in the symptoms, signs, and quality of life of patients with chronic rhinosinusitis with polyposis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximum clinical treatment + Budesonide diluted | Experimental | Drug: Budesonide NasalThe maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril. In this study, the investigator wishes to add to the maximum clinical treatment a daily wash with high volume diluted budesonide. |
| Maximum clinical treatment + Placebo | Placebo comparator | Drug: PlacebosTo compare the efficacy of adding diluted budesonide lavage to maximal clinical treatment, the placebo group is used. The placebo formula is composed of 1% glycerin diluted in water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A minimum nasal polyp score (NPS) of 5 of a maximum of 8 for both nostrils (with at least a score of 2 for each nostril).
- Presence of at least two of the following symptoms prior to screening: nasal blockage / obstruction / congestion or rhinorrhea (anterior or posterior); facial / pressure pain; reduction or loss of smell.
Key exclusion criteria (8 listed)
- A patient under the age of 18, or over 55;
- SNOT-22 with sum of less than 7;
- Patients who have used drugs or therapies that interfere with the results of this clinical trial within 2 months prior to screening: treatment with immunosuppressants; anti-immunoglobulin and within two months prior to screening.
- Initiation of allergen immunotherapy within 3 months prior to first consultation or plan to initiate therapy during the screening period or randomized treatment period;
- Patients who underwent any 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 |
|---|---|---|
| Budesonide NasalAlso: BusonidThe patient performed a lavage once daily with 2mg dilute budesonide. The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril. | Drug | Maximum clinical treatment + Budesonide diluted |
| PlacebosAlso: placebo effectComposed of 1% glycerin diluted in water. The maximum clinical treatment consists of intramuscular injection of Dispropan® in intramuscular injectable suspension and busonid in nasal spray, two sprays of 50mcg in each nostril. | Drug | Maximum clinical treatment + Placebo |
Primary outcome
Evaluate the improvement in the Nasal Polyp Score
Time frame: 16 weeks
To verify, from the change in the Nasal Polyp Score (NPS, range from 0 to 8, higher score indicates larger polyp size), the impact of maximum clinical treatment - intramuscular injection of Dispropan in intramuscular injectable suspension and budesonide in nasal spray, two sprays of 50 mcg in each nostril - plus high-volume diluted budesonide nasal lavage, compared to the same maximum clinical treatment plus high-flow placebo nasal lavage in patients with chronic rhinosinusitis with polyposis without previous nasal surgery for a period of 16 weeks.
3 secondary outcomes
Improves olfactory ability through the University of Pennsylvania Smell Identification Test
Time frame: 16 weeks
Sino-Nasal Outcome Test - 22 (SNOT-22)
Time frame: 16 weeks
Analogic visual scale (VAS)
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide Nasal in people with Chronic Rhinosinusitis (Diagnosis), run by Universidade Estadual de Londrina at 1 site in Brazil.
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 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: status not confirmed, as of the sponsor's last update on 15 Sep 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 Brazil. 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.
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 Marco Aurélio Fornazieri (+55 43 99813-3812, marcofornazieri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the improvement in the Nasal Polyp Score (time frame: 16 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 15 Sep 2022.