4"S" - Seasonal Symptoms Suppression Study

• Register: ClinicalTrials.gov
• Last refreshed on: 6 October 2015
• Main ID: NCT02557269
• Date of registration: 17/07/2015
• Prospective Registration: No
• Primary sponsor: Association Asthma, Bulgaria
• Public title: 4"S" - Seasonal Symptoms Suppression Study 4"S"
• Scientific title: Real Life Proof-of-Concept Study to Assess the Effect of Methylcellulose as add-on "Seal" to the In-season Pharmacologic Rescue Treatment in Subjects With Allergic Rhinitis
• Date of first enrolment: May 2015
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02557269
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Bulgaria

Contacts

• Name: Todor A Popov, MD, PhD
• Affiliation: Medical University of Sofia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female patients

- Age = 18 and = 55 years

- Personal history of rhinitis during the pollen season

- Moderately severe / severe seasonal allergic rhinitis (grass)

- Positive skin prick test for grass/cereals

Exclusion Criteria:

- Subjects with arterial hypertension, arrhythmia or evidence of heart ischemia

- Subjects with other serious chronic comorbidities and bad therapeutic control

- Subjects with nasal polyposis

- Any contraindications for xylometazoline

- Any contraindications for HPMC

- Any contraindications for azelastine

- Any contraindications for bilastine

- Any contraindications for mometasone

- Any contraindications for prednisolone

- Subjects unable to give informed consent

- Pregnant or lactating women



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Seasonal Allergic Rhinitis

Intervention(s)

Drug: Bilastine 20 mg

Drug: Hydroxyl-propyl-methyl cellulose powder - intranasal application

Drug: Azelastine - intranasal application

Drug: Xylometazoline - intranasal application

Drug: Mometasone furoate - intranasal application

Other: Placebo - Lactose powder

Drug: Prednisolone 5 mg

Primary Outcome(s)

Combined Sypmtom and Medication Score [Time Frame: Up to 6 months]

Secondary Outcome(s)

Drug Specific Combined Sypmtom and Medication Score [Time Frame: Up to 6 months]

Visual Analogue Scale [Time Frame: Up to 6 months]

Secondary ID(s)

SSSS2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nasaleze