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CTRI Number  CTRI/2025/04/083804 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 29/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nasal spray]  
Study Design  Other 
Public Title of Study   To assess the effect and safety of fluticasone nasal spray in allergic rhinitis  
Scientific Title of Study   A Prospective Randomized Comparative study - To Asses the Effect and Safety of single daily dose of Fluticasone nasal spray against alternate day regimen in allergic rhinitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikhat Anjum 
Designation  Post Graduate Student 
Affiliation  Adichunchanagiri Institute of Medical Sciences 
Address  Department of ENT, Adichunchanagiri Institute of Medical Sciences, B.G Nagara.

Mandya
KARNATAKA
571448
India 
Phone  8618652770  
Fax    
Email  nikhat08472@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kiran M Naik 
Designation  Professor and HOD 
Affiliation  Adichunchanagiri Institute of Medical Sciences 
Address  Department of ENT, Adichunchanagiri Institute of Medical Sciences, B.G Nagara.

Mandya
KARNATAKA
571448
India 
Phone  9731341027  
Fax    
Email  drkirannaikenthns@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nikhat Anjum 
Designation  Post Graduate Student 
Affiliation  Adichunchanagiri Institute of Medical Sciences 
Address  Department of ENT, Adichunchanagiri Institute of Medical Sciences, B.G Nagara.

Mandya
KARNATAKA
571448
India 
Phone  8618652770  
Fax    
Email  nikhat08472@gmail.com  
 
Source of Monetary or Material Support  
Adichunchanagiri Hospital and Research Centre 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikhat Anjum  Adichunchanagiri Hospital and Research Centre  Department of ENT, Adichunchanagiri Hospital and Research Centre, B.G Nagara -571 448.
Mandya
KARNATAKA 
8618652770

nikhat08472@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Adichunchanagiri Institute of Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fluticasone nasal spray  Single dose daily in allergic rhinitis for 12 weeks 
Comparator Agent  Fluticasone Nasal spray  Single dose in alternative day in allergic rhinitis for 12 weeks 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of both genders belonging to age group 6-60 years having clinical diagnosis on the basis of history and examination of allergic rhinitis symptoms.
2. Both seasonal and perennial allergic rhinitis . 
 
ExclusionCriteria 
Details  1. Patients who have undergone nasal surgery and immunotherapy for the purpose of treating AR.
2. Patients with nasal diseases, like nasal polyp, ear deviated nasal septum, infectious diseases like acute rhinitis, chronic rhinitis, congestive sinusitis, atrophic rhinitis, chronic rhinosinusitis flu associated rhinitis, membrane perforations.
3.Patients with diabetes mellitus, asthma, hypertension and women who wanted to become pregnant or pregnant women or breast feeding women.
4. Patients with psychaitric illness.
5. Patients aged below the 6 years.
6. Patients aged above the 60 years.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison between daily and alternate day regimen of fluticasone intranasal spray for allergic rhinitis.  Daily and alternate day regimen of fluticasone intranasal spray for allergic rhinitis in baseline 8 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of symptom relief in both therapy regimens.  Daily & alternate day symptom relief in both therapy regimens in baseline 8 weeks 12 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

NEED FOR STUDY:

 

o   Allergic rhinitis poses a considerable health concern, with prevalence estimates ranging between 15% to 20%. It affects a significant portion of the population across all age groups, including infants. Over the last four decades, there has been a notice able rise in the incidence of allergic rhinitis, attributed to factors such as industrialization and urbanization, leading to increased exposure to allergens. Additionally, pollution, irritants, lifestyle changes, dietary alterations reducing protective nutrients, decreased infection rates resulting in diminished Th1-type immune response, and stress contribute to this trend. (1)

 

o   AR and MR are overlapping conditions that until recently have been classified as AR. It is becoming clearer that these conditions may behave differently with respect to clinical presentation, comorbidities, and response to treatment. There is ample evidence in the medical literature that shows a synergistic interaction between specific Ig E-mediated responses and air pollutants such as diesel exhaust particulate and ozone.26 –29 Further investigation is required to determine whether MR represents a continuum from AR that develops over time as a result of an enhanced immunologic response secondary to continued exposure to chemicals and/or particulate matter in the home or work environment or merely represents the development of NAR independently of the patient’s atopic status. Regardless, it is important for the clinician not to trivialize the distinction between these two CR conditions because it is clear that the clinical management of MR can be more challenging, leading to increased morbidity and health care costs and decreased quality of life. (2)

o   The findings of this study suggest that the prevalence of self-reported allergic rhinitis (AR) varies significantly across different cities in Mainland China.(3) 

o   The reported prevalence rates ranged from less than 10% to more than 20% among participants surveyed in 11 cities. Additionally, the study identified that 26% of individuals self-reporting AR were categorized as experiencing persistent allergic rhinitis. These results highlight the importance of understanding regional differences in AR prevalence and the substantial proportion of individuals experiencing persistent symptoms, which could have implications for healthcare planning and resource allocation in China.Top of Form(4)

o   This study aims to know the effect and safety of daily versus alternate day regimen of fluticasone nasal spray to maximize efficacy, minimize potential systemic side effects, and improve patient adherence.

 

 
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