Perennial Allergic RhinitisPhase 3LB1108NCT04332978
Topical Nasal Fluticasone Propionate in the Control of Allergic Rhinitis SymptomsPerene
A Phase 3 study testing Fluticasone Propionate in people with Perennial Allergic Rhinitis, run by Libbs Farmacêutica LTDA.
Trial summary
Phase III Study to Demonstrate the non inferiority of PLURAIR® branded nasal topical Fluticasone Propionate (FP) in relation to the FLIXONASE® brand reference drug in the control of nasal symptoms related to perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Fluticasone Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2014to 1 Apr 2020
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Men and women aged ≥ 12 years and <60 years old on the date of the selection visit;
- Clinical history suggestive of perennial allergic rhinitis for at least 02 years;
- Atopy proved through positive evaluation for at least one inhaled allergen (valid positive RAST test performed up to 12 months before the date of the selection visit - or positive Phadiatop® ** performed during the selection period);
- Present the score for reflective nasal symptoms (runny nose, nasal itching, nasal obstruction and sneezing) equal to or greater than the average of 12 points out of a total of 24, during the 4 days preceding the randomization visit OR Present a score of reflective nasal symptoms (runny nose, itchy nose, nasal obstruction and sneezing) at least 12, for at least 4 days, not necessarily consecutive, within a seven-day selection period;
- "Research participant's diary - selection" correctly filled out, considering at least 80% of the completed information regarding nasal and ocular symptoms in the two periods (morning and night);
- Availability of telephone contact for follow-up;
- Signature of the Free and Informed Consent Term and Free and Informed Consent Term, when applicable.
Who cannot join
- Pregnancy or lactation;
- Women who declare that they have the potential to become pregnant and do not want to adopt any contraceptive method, including: sexual abstinence, mechanical barrier, IUD, oral contraceptive, injectable contraceptive, hormonal implant, hormonal transdermal patch, prior sterilization, etc;
- Other clinical forms of rhinitis: seasonal allergic, medication, vasomotor, atrophic, etc;
- History compatible with IVAS or acute sinusitis in the 15 days prior to the selection visit, symptomatic chronic sinusitis, nasal polyposis;
- Concomitant cardiovascular / hepatic / pulmonary / renal / neurological / neoplastic disease and others, which medical criteria may compromise the patient's participation in the study;
- Current smoking or previous smoking for less than 3 months;
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- Cataract, glaucoma, herpes simplex ocular;
- Asthma, with the exception of controlled conditions (GINA Criteria - Global Initiative for Asthma - modified: absence of daytime symptoms, nighttime despair and experiences in experimental activities) without the need for specific medication;
- Previous use of:
- Antihistamine for less than 10 days with the exception of azelastine / astemizole for less than 12 weeks.
- Topical, intranasal and systemic corticosteroids for less than 4 weeks;
- Antileukotriene / anticholinergic / antifungal / antibiotics less than 7 days ago
- Intranasal or systemic decongestant for less than 03 days;
- Non-hormonal anti-inflammatory, including acetylsalicylic acid with use in less than 10 days;
- Use of drugs with the potential to alter cytochrome P450 (eg, ritonavir and ketoconazole, but not exclusively) or with possible clinical influence (eg, tricyclic antidepressants, but not exclusively) or with nasal administration (eg, insulin, but not exclusively);
- History of nasosinusal surgery;
- Results of laboratory selection tests with significant clinical changes (complete blood count, TGO / AST, TGP / ALT, salt, potassium, urea, creatinine, fasting glucose and serum cortisol), which a doctor may compromise the patient's participation in. study;
- Serious illness or condition that the doctor may compromise the patient's participation in the study.
About this study
Official title: Prospective, Comparative, Double-blind, Parallel, Multicentric, Randomized Study Between Two Brands of Fluticasone Propionate Nasal Topic in The Control of Perene Allergic Rhinithis Symptoms
Phase III Study to Demonstrate the non inferiority of PLURAIR® branded nasal topical Fluticasone Propionate (FP) in relation to the FLIXONASE® brand reference drug in the control of nasal symptoms related to perennial allergic rhinitis.
Read the detailed description
This study was conducted to demonstrate the non inferiority of the topical nasal fluticasone propionate of the brand Plurair® in relation to the reference drug Flixonase® in the control of symptoms related to perennial allergic rhinitis. Allergic rhinitis is one of the most common forms of non-infectious rhinitis, characterized mainly by symptoms such as sneezing, runny nose and nasal congestion. Depending on the time of exposure to allergens and the duration of symptoms, allergic rhinitis is classified as perennial (OKUBO, 2009).
Studies for the assessment of perennial allergic rhinitis through symptom analysis used diaries provided to the participants, so that they could describe their symptoms, starting in the screening phase and ending at the end of treatment. In the present study, participants recorded, in the diary, the severity of their rhinitis symptoms (obstruction, runny nose, nasal itching and sneezing) and also associated eye symptoms (watery eyes, itchy eyes and redness) using a four-point scale (0-absent, 1-mild, 2-moderate and 3-severe). For the purpose of analyzing the primary parameter, the total daily reflective nasal symptoms (NRT) was obtained by averaging the total morning and evening scores for each day ([morning NRT + night NRT] / 2) of the individual nasal symptoms - obstruction, itching, runny nose and sneezing - assessed reflexively in the last 12 hours.
This study in its design and analysis of efficacy and safety followed the guidelines of regulatory agencies in the United States of America (FDA, 2000) and Canada (CANADA HEALTH, 2011).
Fluticasone propionate is a potent intranasal corticosteroid with negligible bioavailability, effective in the treatment of nasal symptoms of allergic rhinitis. The onset of the therapeutic effect of fluticasone propionate occurs within 12 hours when 200 μg of the medication is administered once a day (RATNER, 2008).
Following guidelines for the use of fluticasone propionate and guidelines for the assessment of symptoms of perennial allergic rhinitis, the objective of the present clinical study was to evaluate the efficacy and safety of two formulations of fluticasone propionate as a single agent in the treatment of perennial allergic rhinitis through relief of nasal symptoms assessed by recording in the participants' symptom diary.
This study was conducted in accordance with the proposal for the treatment of perennial allergic rhinitis, with local clinical research regulations, with the International Harmonization Conference (ICH) Good Clinical Practices and with the principles of the Declaration Helsinki and their respective revisions.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Fluticasone Propionate
- Keywords
- Plurair, Fluoticasone propionate, topic, nasal
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Drug names: Fluticasone Propionate - PLURAIR® brand Pharmaceutical form: Nasal spray (50mcg / dose) Administration: Topical nasal route Posology 02 jets in each nostril 1 time a day - Single daily topical nasal dose of 200 mcg / day (2 jets / nostril = 100 mcg / nostril), preferably in the morning, upon waking up and at the same time, for 4 weeks.
Manufacturer: Libbs Farmacêutica Ltda. Presentation: Deliver 1 bottle of 120 doses in original packaging Receives: Drug: Fluticasone Propionate |
| Group II | Active comparator | Fluticasone Propionate - FLIXONASE® brand Nasal spray (50mcg / dose) Topical nasal route 02 jets in each nostril once a day - Single daily topical nasal dose of 200 mcg / day (2 jets / nostril = 100 mcg / nostril), preferably in the morning, upon waking up and at the same time, for 4 weeks.
GlaxoSmithKline. Deliver 1 bottle of 120 doses in original packaging Receives: Drug: Fluticasone Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the mean of total reflective nasal symptoms (TSNr)
Patients should be instructed to classify and note the severity of nasal symptoms (itching, sneezing, obstruction and coryza) using the "Research participant's diary", the reflexive way in the last 12 hours, with an assessment in the morning and another at night (twice a day, regardless of specified times), with a 4-point scale below:
0: ABSENT - this symptom is not present.
- Mild - this symptom is present, but does not bother.
- MODERATE - this symptom is present and is substantially received, but it does not get in the way of your daily activities / sleep quality.
- SEVERE - this symptom is present, enters substantially and gets in the way of your daily activities / sleep quality.
Measured: daily records over the 4 weeks of treatment in relation to their baseline value.
Secondary outcomes (5)
Variation of total instant nasal symptoms (TSNi)
Patients should be instructed to classify and note the severity of nasal symptoms (itching, sneezing, obstruction and runny nose) individually in the "Research participant's diary", instantly in the morning (upon waking up and before using the medication, without consideration) specific times), according to the 4-point scale below:
0: ABSENT - this symptom is not present.
- Mild - this symptom is present, but does not bother.
- MODERATE - this symptom is present and substantially bothers, but it does not get in the way of your daily activities / sleep quality.
- SEVERE - this symptom is present, it substantially bothers and gets in the way of your daily activities / sleep quality.
Measured: over the 4 weeks of treatment
Variation of each nasal symptom
Patients should be instructed to classify and note the severity of nasal symptoms (itching, sneezing, obstruction and runny nose) individually in the "Research participant's diary", in a reflexive way in the last 12 hours, with an assessment in the morning and another in the evening (twice a day, regardless of specific times), according to the 4-point scale below:
0: ABSENT - this symptom is not present.
- Mild - this symptom is present, but does not bother.
- MODERATE - this symptom is present and substantially bothers, but it does not get in the way of your daily activities / sleep quality.
- SEVERE - this symptom is present, it substantially bothers and gets in the way of your daily activities / sleep quality.
Measured: over the 4 weeks of treatment
Variation of total ocular symptoms and in each specific ocular symptom
Patients should be instructed to classify and note the severity of eye symptoms individually - tearing, itching and redness - in the "Research participant's diary", in a reflexive way in the last 12 hours, with an assessment in the morning and another at night (two times a day, without considering specific times), according to the 4-point scale below:
0: ABSENT - this symptom is not present.
- Mild - this symptom is present, but does not bother.
- MODERATE - this symptom is present and substantially bothers, but it does not get in the way of your daily activities / sleep quality.
- SEVERE - this symptom is present, it substantially bothers and gets in the way of your daily activities / sleep quality.
Measured: over the 4 weeks of treatment
Patient's overall impression of treatment efficacy at the end of the study
At the end of treatment (4 weeks), each patient should assess their overall satisfaction with the treatment's effectiveness, according to the following scale:
0 = complete improvement of symptoms
- = moderate symptom improvement
- = slight improvement of symptoms
- = no change in symptoms
- = slight worsening of symptoms
- = moderate worsening of symptoms
- = severe worsening of symptoms
Measured: over the 4 weeks of treatment
Researcher's general impression at the end of the study
At the end of the treatment (4 weeks), the researcher will answer about his general impression regarding the effectiveness of the treatment, according to the following scale:
0 = complete improvement of symptoms
- = moderate symptom improvement
- = slight improvement of symptoms
- = no change in symptoms
- = slight worsening of symptoms
- = moderate worsening of symptoms
- = severe worsening of symptoms
Measured: over the 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start4 Jul 2014
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies 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
- Model description
- Phase III, prospective, comparative, double-blind, parallel, multicenter, randomized, non-inferiority clinical study between two brands of nasal topical fluticasone propionate: * Plurair® - Experimental medicine. * Flixonase® - Comparator. Study treatment was allocated by centralized randomization, and each participant remained on the same treatment (dose, dosing regimen and brand) allocated throughout the study period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Libbs Farmacêutica LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332978
- Sponsor's protocol ID
- LB1108
- Acronym
- LB1108
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Comparative, Double-blind, Parallel, Multicentric, Randomized Study Between Two Brands of Fluticasone Propionate Nasal Topic in The Control of Perene Allergic Rhinithis Symptoms
- ClinicalTrials.gov ID
- NCT04332978
- Acronym / sponsor ID
- LB1108 / LB1108
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- Plurair, Fluoticasone propionate, topic, nasal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Libbs Farmacêutica LTDAIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2014
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 3 Apr 2020 (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.
Phase III Study to Demonstrate the non inferiority of PLURAIR® branded nasal topical Fluticasone Propionate (FP) in relation to the FLIXONASE® brand reference drug in the control of nasal symptoms related to perennial allergic rhinitis.
Detailed description
This study was conducted to demonstrate the non inferiority of the topical nasal fluticasone propionate of the brand Plurair® in relation to the reference drug Flixonase® in the control of symptoms related to perennial allergic rhinitis. Allergic rhinitis is one of the most common forms of non-infectious rhinitis, characterized mainly by symptoms such as sneezing, runny nose and nasal congestion. Depending on the time of exposure to allergens and the duration of symptoms, allergic rhinitis is classified as perennial (OKUBO, 2009).
Studies for the assessment of perennial allergic rhinitis through symptom analysis used diaries provided to the participants, so that they could describe their symptoms, starting in the screening phase and ending at the end of treatment. In the present study, participants recorded, in the diary, the severity of their rhinitis symptoms (obstruction, runny nose, nasal itching and sneezing) and also associated eye symptoms (watery eyes, itchy eyes and redness) using a four-point scale (0-absent, 1-mild, 2-moderate and 3-severe). For the purpose of analyzing the primary parameter, the total daily reflective nasal symptoms (NRT) was obtained by averaging the total morning and evening scores for each day ([morning NRT + night NRT] / 2) of the individual nasal symptoms - obstruction, itching, runny nose and sneezing - assessed reflexively in the last 12 hours.
This study in its design and analysis of efficacy and safety followed the guidelines of regulatory agencies in the United States of America (FDA, 2000) and Canada (CANADA HEALTH, 2011).
Fluticasone propionate is a potent intranasal corticosteroid with negligible bioavailability, effective in the treatment of nasal symptoms of allergic rhinitis. The onset of the therapeutic effect of fluticasone propionate occurs within 12 hours when 200 μg of the medication is administered once a day (RATNER, 2008).
Following guidelines for the use of fluticasone propionate and guidelines for the assessment of symptoms of perennial allergic rhinitis, the objective of the present clinical study was to evaluate the efficacy and safety of two formulations of fluticasone propionate as a single agent in the treatment of perennial allergic rhinitis through relief of nasal symptoms assessed by recording in the participants' symptom diary.
This study was conducted in accordance with the proposal for the treatment of perennial allergic rhinitis, with local clinical research regulations, with the International Harmonization Conference (ICH) Good Clinical Practices and with the principles of the Declaration Helsinki and their respective revisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase III, prospective, comparative, double-blind, parallel, multicenter, randomized, non-inferiority clinical study between two brands of nasal topical fluticasone propionate: * Plurair® - Experimental medicine. * Flixonase® - Comparator. Study treatment was allocated by centralized randomization, and each participant remained on the same treatment (dose, dosing regimen and brand) allocated throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Fluticasone PropionateDrug names: Fluticasone Propionate - PLURAIR® brand Pharmaceutical form: Nasal spray (50mcg / dose) Administration: Topical nasal route Posology 02 jets in each nostril 1 time a day - Single daily topical nasal dose of 200 mcg / day (2 jets / nostril = 100 mcg / nostril), preferably in the morning, upon waking up and at the same time, for 4 weeks. Manufacturer: Libbs Farmacêutica Ltda. Presentation: Deliver 1 bottle of 120 doses in original packaging |
| Group II | Active comparator | Drug: Fluticasone PropionateFluticasone Propionate - FLIXONASE® brand Nasal spray (50mcg / dose) Topical nasal route 02 jets in each nostril once a day - Single daily topical nasal dose of 200 mcg / day (2 jets / nostril = 100 mcg / nostril), preferably in the morning, upon waking up and at the same time, for 4 weeks. GlaxoSmithKline. Deliver 1 bottle of 120 doses in original packaging |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Men and women aged ≥ 12 years and <60 years old on the date of the selection visit;
- Clinical history suggestive of perennial allergic rhinitis for at least 02 years;
- Atopy proved through positive evaluation for at least one inhaled allergen (valid positive RAST test performed up to 12 months before the date of the selection visit - or positive Phadiatop® ** performed during the selection period);
- Present the score for reflective nasal symptoms (runny nose, nasal itching, nasal obstruction and sneezing) equal to or greater than the average of 12 points out of a total of 24, during the 4 days preceding the randomization visit OR Present a score of reflective nasal symptoms (runny nose, itchy nose, nasal obstruction and sneezing) at least 12, for at least 4 days, not necessarily consecutive, within a seven-day selection period;
- "Research participant's diary - selection" correctly filled out, considering at least 80% of the completed information regarding nasal and ocular symptoms in the two periods (morning and night);
Key exclusion criteria (18 listed)
- Pregnancy or lactation;
- Women who declare that they have the potential to become pregnant and do not want to adopt any contraceptive method, including: sexual abstinence, mechanical barrier, IUD, oral contraceptive, injectable contraceptive, hormonal implant, hormonal transdermal patch, prior sterilization, etc;
- Other clinical forms of rhinitis: seasonal allergic, medication, vasomotor, atrophic, etc;
- History compatible with IVAS or acute sinusitis in the 15 days prior to the selection visit, symptomatic chronic sinusitis, nasal polyposis;
- Concomitant cardiovascular / hepatic / pulmonary / renal / neurological / neoplastic disease and others, which medical criteria may compromise the patient's participation in the study;
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 |
|---|---|---|
| Fluticasone Propionate | Drug | Group I, Group II |
Primary outcome
Variation of the mean of total reflective nasal symptoms (TSNr)
Time frame: daily records over the 4 weeks of treatment in relation to their baseline value.
Patients should be instructed to classify and note the severity of nasal symptoms (itching, sneezing, obstruction and coryza) using the "Research participant's diary", the reflexive way in the last 12 hours, with an assessment in the morning and another at night (twice a day, regardless of specified times), with a 4-point scale below: 0: ABSENT - this symptom is not present. 1. Mild - this symptom is present, but does not bother. 2. MODERATE - this symptom is present and is substantially received, but it does not get in the way of your daily activities / sleep quality. 3. SEVERE - this symptom is present, enters substantially and gets in the way of your daily activities / sleep quality.
5 secondary outcomes
Variation of total instant nasal symptoms (TSNi)
Time frame: over the 4 weeks of treatment
Variation of each nasal symptom
Time frame: over the 4 weeks of treatment
Variation of total ocular symptoms and in each specific ocular symptom
Time frame: over the 4 weeks of treatment
Patient's overall impression of treatment efficacy at the end of the study
Time frame: over the 4 weeks of treatment
Researcher's general impression at the end of the study
Time frame: over the 4 weeks of treatment
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 8 Apr 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone Propionate in people with Perennial Allergic Rhinitis, run by Libbs Farmacêutica LTDA.
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 7 inclusion and 18 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 8 Apr 2020. 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?
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?
Variation of the mean of total reflective nasal symptoms (TSNr) (time frame: daily records over the 4 weeks of treatment in relation to their baseline value.). 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 8 Apr 2020.