Protocol summary

Study aim
Evaluation and comparison of the efficacy of Cromolyn sodium , Mometazone, and Azelastin in improving nasal symptoms in patients with moderate to severe persistent Allergic Rhinitis.
Design
A Phase 2, randomized, double blind, parallel-group, controlled clinical trial involving 108 patients; Random Allocation software was used for randomization.
Settings and conduct
Patient symptoms are assessed and scored using the Total Nasal Symptom Score (TNSS). This questionnaire comprises four components nasal congestion, rhinorrhea, sneezing, and nasal itching each scored from 0 to 3 based on symptom severity, resulting in a total score ranging from 0 to 12. Patients will be evaluated on two occasions: day one (prior to initiating medication) and day twenty-eight (after starting medication); necessary information will be collected from the patients and recorded on data forms. Matching for age and sex will be performed, and the study will be conducted in a double-blind manner using identical spray containers prepared by a pharmacist and assigned to three groups ;ensuring that neither the administrator nor the patient is aware of the specific spray type. The study will be conducted at the Al-Zahra ENThospital in Zahedan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with a confirmed diagnosis of Allergic Rhinitis; age 18–50 years; moderate-to-severe Allergic Rhinitis based on symptom severity; and provision of written informed consent to participate in the study.
Intervention groups
For Sodium Cromoglicate, the dosage is one spray in each nostril, four times daily; For Azelastin, is one spray in each nostril, twice daily; For Mometazone is one spray in each nostril, twice daily.
Main outcome variables
Recipients of mometasone spray in the control group are compared with recipients of azelastine and cromolyn sodium sprays regarding their response to treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260919071117N1
Registration date: 2026-10-02, 1405/07/10
Registration timing: prospective

Last update: 2026-10-02, 1405/07/10
Update count: 0
Registration date
2026-10-02, 1405/07/10
Registrant information
Name
Elham Jannesari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3232 6423
Email address
e.jannesari@zaums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-23, 1405/08/01
Expected recruitment end date
2027-05-20, 1406/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Cromolyn Sodium Mometasone and Azelastine Nasal Sprays' in Improving Nasal Symptoms in Patients with Moderate to Severe Persistent Allergic Rhinitis.
Public title
Effectiveness of Cromolyn Sodium Mometasone and Azelastine Nasal Sprays' in Allergic Rhinitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with definite diagnosis of Persistent Allergic Rhinitis based on ARIA criteria, whose symptoms are present more than 3 days a week and for more than 3 consecutive weeks. Age between 18 and 50 years Suffering from moderate to severe allergic rhinitis based on the severity of symptoms which include:Sleep disorder caused by symptoms.Disruption in daily activities including work, education, sports and leisure time. Existence of annoying and chronic symptoms including rhinorrhea (runny nose), congestion, sneezing and itchy nose. Informed written consent to participate in the research.
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
They are placed randomly in a block way (using Random Allocation software) in three equal spheres. With box unit.
Blinding (investigator's opinion)
Double blinded
Blinding description
A pharmacist has coded three spray medications—packaged in containers identical in color, shape, and volume as Code 1, Code 2, and Code 3, with each code corresponding to a specific drug. A clinical caregiver hands one of the coded sprays to each patient for use, while neither the patient nor the caregiver knows which drug corresponds to which code. Ultimately, following an analysis by the researchers, the specific drug associated with each code is revealed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences.
Street address
Zahedan university of medical science, Daneshgah street.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2026-08-24, 1405/06/02
Ethics committee reference number
IR.ZAUMS.REC.1405.171

Health conditions studied

1

Description of health condition studied
Allergic Rhinitis.
ICD-10 code
J30.8
ICD-10 code description
Other allergic rhinitis

Primary outcomes

1

Description
Nasal symptoms.
Timepoint
Day 1 before starting the medication and Day 28 after administration.
Method of measurement
Total nasal symptom score Questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Cromolyn spray
Category
Treatment - Drugs

2

Description
Intervention group: Azelastin Spray
Category
Treatment - Drugs

3

Description
Intervention group: Mometasone spray group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Zahra hospital
Full name of responsible person
Elham Jannesari
Street address
Motahari hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3321 9917
Email
e.jannesari@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Elham Jannesari
Street address
Daneshgah street Zahedan City.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 913 209 6994
Email
e.jannesari@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan medical center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Elham Jannesari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Al zahra hospital;Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 905 027 6994
Email
e.jannesari@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Elham Jannesari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Al zahra hospital Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 905 027 6994
Email
e.jannesari@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Elham Jannesari
Position
Doctor/resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Al zahra hospital; Motahari Blvd;Zahedan city
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 905 027 6994
Email
e.jannesari@zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No information exist.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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