| 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
|
|
|
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
|
|
|
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.
|