Ignite Creation Date:
2024-05-06 @ 7:32 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02557269
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2015-07-17
Brief Title:
4S - Seasonal Symptoms Suppression Study
Sponsor:
Association Asthma Bulgaria
Organization:
Association Asthma Bulgaria
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
4S
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None