Perennial Allergic Rhinitis Clinical Trial
— LB1108Official 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
NCT number | NCT04332978 |
Other study ID # | LB1108 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 4, 2014 |
Est. completion date | April 1, 2020 |
Verified date | April 2020 |
Source | Libbs Farmacêutica LTDA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 566 |
Est. completion date | April 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Libbs Farmacêutica LTDA |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
daily records over the 4 weeks of treatment in relation to their baseline value. | |
Secondary | 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. |
over the 4 weeks of treatment | |
Secondary | 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. |
over the 4 weeks of treatment | |
Secondary | 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. |
over the 4 weeks of treatment | |
Secondary | 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 |
over the 4 weeks of treatment | |
Secondary | 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 |
over the 4 weeks of treatment |
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