4"S" - Seasonal Symptoms Suppression Study (4"S")

September 21, 2015 updated by: Prof. Todor Popov, Association Asthma, Bulgaria

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Rationale. Assessment and follow up of specifically sensitized subjects with allergic rhinitis during the pollen season is traditionally based on symptom scores. Accounting for the use of rescue medication on top of symptom scores provides another dimension to the overall clinical characterization of the patients. Thus, using "combined symptom and medication scores" (CSMS) allows thorough characterization of the disease course. Guidelines recommend that CSMS are used for assessment of the effect of allergen specific immunotherapy in subjects with allergic rhinitis. Different allergic rhinitis management strategies can be evaluated and compared by means of CSMS. In the update of the ARIA guidelines of 2010, 24 recommendations have been made in relation to pharmacologic treatment. Special position paper has been devoted to severe chronic upper airway disease (SCUAD), the treatment for which has been earmarked as unmet need.

Consequently, a standardized and universally recognized rescue treatment strategy does not exist. The most common approach for handling nasal complaints in real life consists in using rescue medication for symptoms whenever they appear. This is certainly the case when symptoms appear for the first time ever, or when patients do not want to resort to allergen specific immunotherapy (ASIT) and / or regular oral antihistamine treatment for financial reasons or personal beliefs. Under these circumstances, a long list of pharmacological choices for local or systemic application is possible including antihistamines, corticosteroids, leukotriene antagonists, cromones and antimuscarinic drugs.

Formulations for local application in the nose appeal to patients with their ease of use and immediate relief. They comprise a variety of generic drugs: decongestants, antihistamines, corticosteroids and antimuscarinics. The fact that they are not ingested makes them first choice for people reluctant to take oral medications. In many cases it is possible to control the symptoms of allergic rhinitis with these formulations used per se or as adjunct rescue medication in the course of ASIT.

The question stays whether the effectiveness of nasally applied drugs can further be improved. Despite the good rationale for their mechanism of action, their efficacy is diminished by the cleaning mechanisms of the nose, rhinorrhea in particular. Slowing down of the clearance of the nasal mucosa and prolonging the contact time with the nasal mucosa would enhance their pharmaceutical effects. The investigators have demonstrated by objectively measuring nasal flow rates that "sealing" in place locally applied oxymetazoline in subjects with persistent allergic rhinitis by means of commercially available hydroxyl-propyl-methyl-cellulose (HPMC) significantly enhances the resulting decongestion and that this effect is augmented over a time span of 2 weeks without noticeable tachyphylaxis or adverse events.

The investigators set the aim to investigate whether this beneficial effect of HPMC translates into clinical benefits in a real life clinical trial for other available drug preparations for nasal delivery.

Study design. ASIT naïve patients sensitized to grass pollens will be recruited for the study. All of the patients will be instructed to treat bothersome in-season symptoms when they appear (on as needed, pro re nata basis) with rescue medication. The patients 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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group HPMC
Hydroxyl-propyl-methyl-cellulose (HPMC) powder added immediately after other intranasal treatment options
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
Other Names:
  • Allergodil
Drug: Mometasone furoate - intranasal application
Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment
Other Names:
  • Nasonex
Drug: Hydroxyl-propyl-methyl cellulose powder - intranasal application
Applied intranasally immediately after every application other intranasal formulation
Other Names:
  • Nasaleze
Drug: Bilastine 20 mg
1 tablet per os - as needed
Other Names:
  • Fortecal
Drug: Prednisolone 5 mg
Per os - if needed (only in case of broncial obstruction)
PLACEBO_COMPARATOR: Group Placebo
Lactose powder (placebo) added immediately after other intranasal treatment options
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
Other Names:
  • Allergodil
Drug: Mometasone furoate - intranasal application
Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment
Other Names:
  • Nasonex
Drug: Bilastine 20 mg
1 tablet per os - as needed
Other Names:
  • Fortecal
Drug: Prednisolone 5 mg
Per os - if needed (only in case of broncial obstruction)
Other: Placebo - Lactose powder
Applied intranasally immediately after every application other intranasal formulation
OTHER: Group Immunotherapy
Immunotherapy group with grass allergens sublingually (Staloral #688) and rescue medication
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
Other Names:
  • Allergodil
Drug: Mometasone furoate - intranasal application
Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment
Other Names:
  • Nasonex
Drug: Bilastine 20 mg
1 tablet per os - as needed
Other Names:
  • Fortecal
Drug: Prednisolone 5 mg
Per os - if needed (only in case of broncial obstruction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined Sypmtom and Medication Score
Time Frame: Up to 6 months
The primary outcome will be comparison of total combined symptoms and medication scores (TCSMS) collected from patients' diaries for a fixed period during the pollen season
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Specific Combined Sypmtom and Medication Score
Time Frame: Up to 6 months
Drug specific combined symptoms and medication scores (DsCSMS) will be calculated for each rescue medication and compared between the 3 arms of the trial.
Up to 6 months
Visual Analogue Scale
Time Frame: Up to 6 months
Visual analogue scale (VAS) scores (Scores range from 0 [no symptoms] to 10 [worst possible symptoms]) at each visit and compared between groups.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Asthma, Bulgaria

Collaborators

Nasaleze

Investigators

  • Principal Investigator: Todor A Popov, MD, PhD, Medical University of Sofia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (ESTIMATE)

September 23, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSSS2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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