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Not yet recruitingNCT07532993Updated Apr 16, 2026

Comparison of Antihistamine and Antileukotriene Add-On Therapy to Intranasal Corticosteroid in Allergic Rhinitis

A Phase 4 interventional study of Mometasone Furoate Nasal spray and Loratadine 10 Mg in Allergic Rhinitis (AR), sponsored by Liaquat National Hospital & Medical College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Liaquat National Hospital & Medical College · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
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Study summary

Allergic rhinitis is a very common condition that can cause symptoms such as sneezing, a runny nose, nasal blockage, and itching in the nose. These symptoms can interfere with sleep, daily activities, and overall quality of life. Although several medicines are available to treat allergic rhinitis, it is not always clear which combination of treatments works best for patients in everyday clinical practice.

The purpose of this study is to compare two commonly used treatment combinations for allergic rhinitis in adults. One group of participants will receive an intranasal corticosteroid along with an oral antihistamine. The other group will receive an intranasal corticosteroid along with an oral antileukotriene. Both treatment approaches aim to reduce inflammation and improve symptoms, but they act through different pathways in the body.

This study is designed as a randomized controlled trial. Participants who meet the eligibility criteria will be assigned by chance to one of the two treatment groups. This method helps ensure that the comparison between treatments is fair and unbiased.

The main goal of the study is to find out whether one treatment combination provides better relief of nasal symptoms than the other, or if both treatments are equally effective. To assess this, participants' symptoms will be recorded using a structured symptom scoring system at the start of the study and during follow-up visits.

Participants will be evaluated at baseline and at scheduled follow-up visits. Changes in their symptoms over time will be carefully monitored and compared between the two groups. The results of this study may help doctors choose the most effective treatment approach for adults with allergic rhinitis and support better evidence-based care.

This study has been reviewed and approved by the institutional ethical review committee. Participation in the study is voluntary, and informed consent will be obtained from all participants before enrollment.

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Conditions studied

  • Allergic Rhinitis (AR)

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03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 32 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Liaquat National Hospital & Medical College is the lead sponsor of 33 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-60 years with a clinical diagnosis of allergic rhinitis.
  • Patients with moderate to severe symptoms (nasal obstruction, rhinorrhea, sneezing, itching).
  • Patients willing to participate and provide .
  • Patients not using antihistamines, antileukotrienes, or for at least 2 weeks prior to enrollment.

Exclusion criteria

Exclusion Criteria:

  • Patients with bronchial asthma, chronic rhinosinusitis, nasal polyps, or significant nasal pathology.
  • Known to study medications.
  • Pregnant or lactating women.
  • Use of systemic or immunotherapy within the past 4 weeks.
  • Active nasal or sinus infection.
  • Patients with significant systemic illness or unable to comply with follow-up.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Active comparator
    Intranasal Corticosteroid + Oral Antihistamine

    Participants in this group will receive an intranasal corticosteroid in combination with an oral antihistamine for the treatment of allergic rhinitis. The treatment aims to reduce nasal inflammation and control symptoms such as sneezing, nasal discharge, itching, and nasal obstruction.

    Drug: Mometasone Furoate Nasal spray · Drug: Loratadine 10 Mg

  • Active comparator
    Intranasal Corticosteroid + Oral Antileukotriene

    Participants in this group will receive an intranasal corticosteroid in combination with an oral antileukotriene for the treatment of allergic rhinitis. This treatment approach targets inflammatory pathways to improve nasal symptoms and overall disease control.

    Drug: Mometasone Furoate Nasal spray · Drug: Montelukast 10 mg

Interventions

  • Mometasone furoate nasal spray (50 micrograms per spray) will be administered as two sprays per nostril once daily as an intranasal corticosteroid to reduce nasal mucosal inflammation and improve symptoms of allergic rhinitis.

    Also known as: Nasomet

  • Loratadine 10 mg will be administered orally once daily as an antihistamine to control symptoms of allergic rhinitis, including sneezing, itching, and rhinorrhea.

    Also known as: Softin

  • Montelukast 10 mg will be administered orally once daily as an antileukotriene agent to reduce inflammation and improve symptoms in patients with allergic rhinitis.

    Also known as: Myteka

06

What researchers measure

Primary outcomes

  1. Change in Total Nasal Symptom Score (TNSS)

    Total Nasal Symptom Score (TNSS) will be used to assess symptom severity in patients with allergic rhinitis. TNSS includes four symptoms: nasal obstruction, rhinorrhea, sneezing, and nasal itching, each scored from 0 (no symptoms) to 3 (severe symptoms), with a total score ranging from 0 to 12. The primary outcome will be the change in TNSS from baseline to 4 weeks after initiation of treatment.

    Time frame: Baseline to 4 weeks

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared due to institutional policies and to protect participant confidentiality.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.

Of 34 phase 4 interventional studies under Rhinitis, Allergic, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 38. This study's planned 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2026
First posted
Apr 16, 2026
StartEst.
Sep 2026
Primary completionEst.
Feb 2027
CompletionEst.
May 2027
Last update
Apr 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07532993
Lead sponsor
Liaquat National Hospital & Medical College
Responsible party
Raja Muhammad Suleman Qadir (Dr. Raja Muhammad Suleman Qadir, Liaquat National Hospital & Medical College) — Principal investigator
First posted
Apr 16, 2026
Start date
Sep 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Apr 16, 2026

Study contacts

Raja Muhammad Suleman Qadir, MBBS
Contact
isuleman52435@gmail.com
+923055992616
Ahmad Nawaz Ahmad, MBBS, MCPS, FCPS, MHPE
study director · Liaquat National Hospital and Medical College
Raja Muhammad Suleman Qadir, MBBS
principal investigator · Liaquat National Hospital and Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Loratadine · Montelukast

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