4"S" - Seasonal Symptoms Suppression Study

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).

Conditions

• Seasonal Allergic Rhinitis

Interventions

DRUG

Xylometazoline - intranasal application

Applied as needed up to 5 consecutive days when prominent congestion

DRUG

Azelastine - intranasal application

Applied as needed when prominent symptom is rhinorrhea

DRUG

Mometasone furoate - intranasal application

Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment

DRUG

Hydroxyl-propyl-methyl cellulose powder - intranasal application

Applied intranasally immediately after every application other intranasal formulation

OTHER

Placebo - Lactose powder

Applied intranasally immediately after every application other intranasal formulation

DRUG

Bilastine 20 mg

1 tablet per os - as needed

DRUG

Prednisolone 5 mg

Per os - if needed (only in case of broncial obstruction)

Sponsors & Collaborators

• Nasaleze

  collaborator INDUSTRY

• Association Asthma, Bulgaria

  lead OTHER

Principal Investigators

• Todor A Popov, MD, PhD · Medical University of Sofia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2015-10-31

Completion

2015-12-31

Countries

• Bulgaria

Study Locations