Allergic Rhinitis (AR)Phase 4NCT07532993
Comparison of Antihistamine and Antileukotriene Add-On Therapy to Intranasal Corticosteroid in Allergic Rhinitis
A Phase 4 study testing Mometasone Furoate Nasal spray, Loratadine 10 Mg and Montelukast 10 mg in people with Allergic Rhinitis (AR), run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis (AR)
- What is being tested?
- Mometasone Furoate Nasal spray, Loratadine 10 Mg and Montelukast 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- Sep 2026to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 informed consent.
- Patients not using antihistamines, antileukotrienes, or corticosteroids for at least 2 weeks prior to enrollment.
Who cannot join
- Patients with bronchial asthma, chronic rhinosinusitis, nasal polyps, or significant nasal pathology.
- Known hypersensitivity to study medications.
- Pregnant or lactating women.
- Use of systemic corticosteroids or immunotherapy within the past 4 weeks.
- Active nasal or sinus infection.
- Patients with significant systemic illness or unable to comply with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Liaquat National Hospital and Medical College
Karachi, Sindh, 75400
Raja Muhammad Suleman Qadir, MBBS, +923055992616, isuleman52435@gmail.com
About this study
Official title: Comparison of Intranasal Corticosteroid Plus Oral Antihistamine Versus Intranasal Corticosteroid Plus Oral Antileukotriene in Patients With Allergic Rhinitis
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.
Read more
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.
- Conditions
- Allergic Rhinitis (AR)
- Being tested
- Mometasone Furoate Nasal spray, Loratadine 10 Mg, Montelukast 10 mg
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate Nasal sprayDrug
Also called Nasomet
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.
Loratadine 10 MgDrug
Also called Softin
Loratadine 10 mg will be administered orally once daily as an antihistamine to control symptoms of allergic rhinitis, including sneezing, itching, and rhinorrhea.
Montelukast 10 mgDrug
Also called Myteka
Montelukast 10 mg will be administered orally once daily as an antileukotriene agent to reduce inflammation and improve symptoms in patients with allergic rhinitis.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Corticosteroid + Oral Antihistamine | Active comparator | 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. Receives: Drug: Mometasone Furoate Nasal spray; Drug: Loratadine 10 Mg |
| Intranasal Corticosteroid + Oral Antileukotriene | Active comparator | 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. Receives: Drug: Mometasone Furoate Nasal spray; Drug: Montelukast 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Rhinitis (AR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a parallel manner to one of two treatment groups. One group will receive an intranasal corticosteroid in combination with an oral antihistamine, while the other group will receive an intranasal corticosteroid in combination with an oral antileukotriene. Outcomes will be assessed and compared between the two groups over the study period.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raja Muhammad Suleman Qadir, Liaquat National Hospital & Medical College
- Investigators
- Ahmad Nawaz Ahmad, MBBS, MCPS, FCPS, MHPE, Study director, Liaquat National Hospital and Medical CollegeRaja Muhammad Suleman Qadir, MBBS, Principal investigator, Liaquat National Hospital and Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532993
- Sponsor's protocol ID
- 1309-2025-LNH-ERC
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intranasal Corticosteroid Plus Oral Antihistamine Versus Intranasal Corticosteroid Plus Oral Antileukotriene in Patients With Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT07532993
- Acronym / sponsor ID
- 1309-2025-LNH-ERC
- Conditions
- Allergic Rhinitis (AR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a parallel manner to one of two treatment groups. One group will receive an intranasal corticosteroid in combination with an oral antihistamine, while the other group will receive an intranasal corticosteroid in combination with an oral antileukotriene. Outcomes will be assessed and compared between the two groups over the study period.
| Arm | Type | Receives |
|---|---|---|
| Intranasal Corticosteroid + Oral Antihistamine | Active comparator | Drug: Mometasone Furoate Nasal spray, Drug: Loratadine 10 MgParticipants 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. |
| Intranasal Corticosteroid + Oral Antileukotriene | Active comparator | Drug: Mometasone Furoate Nasal spray, Drug: Montelukast 10 mgParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 informed consent.
- Patients not using antihistamines, antileukotrienes, or corticosteroids for at least 2 weeks prior to enrollment.
Key exclusion criteria (6 listed)
- Patients with bronchial asthma, chronic rhinosinusitis, nasal polyps, or significant nasal pathology.
- Known hypersensitivity to study medications.
- Pregnant or lactating women.
- Use of systemic corticosteroids or immunotherapy within the past 4 weeks.
- Active nasal or sinus infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone Furoate Nasal sprayAlso: NasometMometasone 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. | Drug | Intranasal Corticosteroid + Oral Antihistamine, Intranasal Corticosteroid + Oral Antileukotriene |
| Loratadine 10 MgAlso: SoftinLoratadine 10 mg will be administered orally once daily as an antihistamine to control symptoms of allergic rhinitis, including sneezing, itching, and rhinorrhea. | Drug | Intranasal Corticosteroid + Oral Antihistamine |
| Montelukast 10 mgAlso: MytekaMontelukast 10 mg will be administered orally once daily as an antileukotriene agent to reduce inflammation and improve symptoms in patients with allergic rhinitis. | Drug | Intranasal Corticosteroid + Oral Antileukotriene |
Primary outcome
Change in Total Nasal Symptom Score (TNSS)
Time frame: Baseline to 4 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mometasone Furoate Nasal spray, Loratadine 10 Mg and Montelukast 10 mg in people with Allergic Rhinitis (AR), run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raja Muhammad Suleman Qadir, MBBS (+923055992616, isuleman52435@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Nasal Symptom Score (TNSS) (time frame: Baseline to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.