4"S" - Seasonal Symptoms Suppression Study
4"S"
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
1 other identifier
interventional
60
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 23, 2015
September 1, 2015
5 months
July 17, 2015
September 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined Sypmtom and Medication Score
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 Outcomes (2)
Drug Specific Combined Sypmtom and Medication Score
Up to 6 months
Visual Analogue Scale
Up to 6 months
Study Arms (3)
Group HPMC
ACTIVE COMPARATORHydroxyl-propyl-methyl-cellulose (HPMC) powder added immediately after other intranasal treatment options
Group Placebo
PLACEBO COMPARATORLactose powder (placebo) added immediately after other intranasal treatment options
Group Immunotherapy
OTHERImmunotherapy group with grass allergens sublingually (Staloral #688) and rescue medication
Interventions
Applied as needed up to 5 consecutive days when prominent congestion
Applied as needed when prominent symptom is rhinorrhea
Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment
Applied intranasally immediately after every application other intranasal formulation
Applied intranasally immediately after every application other intranasal formulation
1 tablet per os - as needed
Per os - if needed (only in case of broncial obstruction)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Association Asthma, Bulgarialead
- Nasalezecollaborator
Study Sites (1)
Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma
Sofia, 1431, Bulgaria
Related Publications (5)
Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, Durham SR, Jacobsen L, Malling HJ, Mosges R, Papadopoulos NG, Rak S, Rodriguez del Rio P, Valovirta E, Wahn U, Calderon MA; European Academy of Allergy and Clinical Immunology. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014 Jul;69(7):854-67. doi: 10.1111/all.12383. Epub 2014 Apr 25.
PMID: 24761804BACKGROUNDCalderon MA, Bernstein DI, Blaiss M, Andersen JS, Nolte H. A comparative analysis of symptom and medication scoring methods used in clinical trials of sublingual immunotherapy for seasonal allergic rhinitis. Clin Exp Allergy. 2014 Oct;44(10):1228-39. doi: 10.1111/cea.12331.
PMID: 24773171BACKGROUNDBrozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.
PMID: 20816182BACKGROUNDBousquet J, Bachert C, Canonica GW, Casale TB, Cruz AA, Lockey RJ, Zuberbier T; Extended Global Allergy and Asthma European Network, World Allergy Organization and Allergic Rhinitis and its Impact on Asthma Study Group. Unmet needs in severe chronic upper airway disease (SCUAD). J Allergy Clin Immunol. 2009 Sep;124(3):428-33. doi: 10.1016/j.jaci.2009.06.027. Epub 2009 Aug 5.
PMID: 19660803BACKGROUNDValerieva A, Popov TA, Staevska M, Kralimarkova T, Petkova E, Valerieva E, Mustakov T, Lazarova T, Dimitrov V, Church MK. Effect of micronized cellulose powder on the efficacy of topical oxymetazoline in allergic rhinitis. Allergy Asthma Proc. 2015 Nov-Dec;36(6):e134-9. doi: 10.2500/aap.2015.36.3879. Epub 2015 Jun 29.
PMID: 26133030BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todor A Popov, MD, PhD
Medical University of Sofia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 17, 2015
First Posted
September 23, 2015
Study Start
May 1, 2015
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
September 23, 2015
Record last verified: 2015-09