4"S" - Seasonal Symptoms Suppression Study

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

ASIT naïve patients sensitized to grass pollens will be recruited for the study. All of them will be instructed to treat bothersome in-season symptoms when they appear (on as needed, pro re nata basis) with rescue medication. They will be given 5 different options and will be informed about the effects of each of them in order to make their optimal choice for different symptoms and their combination: local decongestant (xylomethazoline, when congestion is leading), local antihistamine (azelastine, when itching, sneezing and rhinorhea a predominant), nasal corticosteroid (momethasone, when all nasal symptoms are pressing and no adequate relief is obtained form the other 2 local treatments), oral antihistamine (bilastine, when itching and sneezing persist despite the local treatments) and oral corticosteroid (prednisolone, when any or all symptoms become unbearable despite the other suggested treatments). Patients who are reluctant to use immunotherapy or who are too late to initiate it will be randomized to be treated with the listed medications on as needed basis, the nasally applied formulations will be followed by either HPMC to prolong and enhance their effect (Group HPMC) or placebo (lactose powder) (Group Placebo) to serve as control. Patients indicated and willing to carry out ASIT will be treated according to the standard protocol with grass allergens sublingually (Staloral #688) and will receive rescue medication (Group Immunotherapy).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association Asthma, Bulgaria
• Collaborator: Nasaleze
• Treatments: Azelastine; Mometasone Furoate; Prednisolone; Xylometazoline

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