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

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ClinicalTrials.gov Identifier: NCT02557269
Recruitment Status : Unknown
Verified September 2015 by Prof. Todor Popov, Association Asthma, Bulgaria.
Recruitment status was:  Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Nasaleze
Information provided by (Responsible Party):
Prof. Todor Popov, Association Asthma, Bulgaria

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).

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Xylometazoline - intranasal application Drug: Azelastine - intranasal application Drug: Mometasone furoate - intranasal application Drug: Hydroxyl-propyl-methyl cellulose powder - intranasal application Other: Placebo - Lactose powder Drug: Bilastine 20 mg Drug: Prednisolone 5 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 Name: Allergodil

Drug: Mometasone furoate - intranasal application
Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment
Other Name: Nasonex

Drug: Hydroxyl-propyl-methyl cellulose powder - intranasal application
Applied intranasally immediately after every application other intranasal formulation
Other Name: Nasaleze

Drug: Bilastine 20 mg
1 tablet per os - as needed
Other Name: 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 Name: Allergodil

Drug: Mometasone furoate - intranasal application
Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment
Other Name: Nasonex

Other: Placebo - Lactose powder
Applied intranasally immediately after every application other intranasal formulation

Drug: Bilastine 20 mg
1 tablet per os - as needed
Other Name: Fortecal

Drug: Prednisolone 5 mg
Per os - if needed (only in case of broncial obstruction)

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 Name: Allergodil

Drug: Mometasone furoate - intranasal application
Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment
Other Name: Nasonex

Drug: Bilastine 20 mg
1 tablet per os - as needed
Other Name: Fortecal

Drug: Prednisolone 5 mg
Per os - if needed (only in case of broncial obstruction)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557269


Locations
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Bulgaria
Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Association Asthma, Bulgaria
Nasaleze
Investigators
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Principal Investigator: Todor A Popov, MD, PhD Medical University of Sofia
Publications:

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Responsible Party: Prof. Todor Popov, Professor, Association Asthma, Bulgaria
ClinicalTrials.gov Identifier: NCT02557269    
Other Study ID Numbers: SSSS2015
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Keywords provided by Prof. Todor Popov, Association Asthma, Bulgaria:
Pollenosis
Congestion
Mucoadhesive Treatment
Nasal Decongestant
Nasal Antihistamine
Nasal Corticosteroid
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Azelastine
Prednisolone
Xylometazoline
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Dermatologic Agents
Anti-Allergic Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Lipoxygenase Inhibitors