Persistent Allergic RhinitisPhase 4NCT07593898
Oxymetazoline Bridge Therapy With Intranasal Corticosteroids in Pediatric Allergic Rhinitis
A Phase 4 study testing Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg and Oxymetazoline 0.05% nasal solution in people with Persistent Allergic Rhinitis, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Persistent allergic rhinitis in children is commonly treated with intranasal corticosteroids (INS), which are considered first-line therapy. However, the delayed onset of action of INS may reduce patient adherence and delay symptom relief. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Persistent Allergic Rhinitis
- What is being tested?
- Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg and Oxymetazoline 0.05% nasal solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2025to 16 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 4 to 18 years
- Diagnosis of moderate-to-severe persistent allergic rhinitis according to ARIA guidelines
- Ability to comply with study procedures
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Mechanical nasal obstruction (nasal polyposis, severe septal deviation, or adenoid hypertrophy)
- Acute upper respiratory tract infection within the previous 2 weeks
- Active smoking or significant passive smoke exposure
- Current use of allergic rhinitis medications
- Use of intranasal corticosteroids within the previous 3 months
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
Izmir, 35180
About this study
Official title: Short-Term Nasal Decongestant as Bridge Therapy Combined With Intranasal Corticosteroids in Children With Persistent Allergic Rhinitis: A Randomized Controlled Trial
Persistent allergic rhinitis in children is commonly treated with intranasal corticosteroids (INS), which are considered first-line therapy. However, the delayed onset of action of INS may reduce patient adherence and delay symptom relief. This randomized controlled study evaluates whether adding short-term oxymetazoline nasal spray during the first 5 days of INS treatment ("bridge therapy") improves clinical outcomes, nasal airflow, quality of life, nasal inflammation, and medication adherence in children with persistent allergic rhinitis.
Children aged 4-18 years with moderate-to-severe persistent allergic rhinitis were randomized into two parallel groups. One group received mometasone furoate nasal spray alone for 4 weeks, while the other group received mometasone furoate combined with oxymetazoline during the first 5 days of treatment. Clinical symptoms, Peak Nasal Inspiratory Flow (PNIF), Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Nasal Nitric Oxide (nNO), and Medication Adherence Rating Scale (MARS) scores were evaluated.
Read the detailed description
Allergic rhinitis is one of the most common chronic inflammatory diseases in childhood and significantly affects sleep quality, school performance, daily functioning, and quality of life. Intranasal corticosteroids (INS) are recommended as first-line therapy because of their strong anti-inflammatory effects. However, the onset of symptom relief may take several days or weeks, especially in patients with severe nasal congestion. This delayed onset may negatively affect treatment adherence and early treatment satisfaction.
Short-term use of topical nasal decongestants may provide rapid nasal patency and facilitate delivery of intranasal corticosteroids into the nasal cavity. This study investigates whether short-term oxymetazoline therapy added to the initiation of INS treatment can function as a "bridge therapy" in children with persistent allergic rhinitis.
This prospective randomized controlled study enrolled children aged 4-18 years diagnosed with moderate-to-severe persistent allergic rhinitis according to ARIA guidelines. Participants were randomized into two parallel treatment groups:
- Intranasal corticosteroid monotherapy group (mometasone furoate for 4 weeks)
- Combination therapy group (mometasone furoate for 4 weeks plus oxymetazoline during the first 5 days)
Clinical symptom severity was assessed using Total Nasal Symptom Score (TNSS). Objective nasal airflow was evaluated with Peak Nasal Inspiratory Flow (PNIF). Nasal inflammation was assessed using Nasal Nitric Oxide (nNO). Disease-specific quality of life was measured using the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), and treatment adherence was evaluated using the Medication Adherence Rating Scale (MARS).
The primary objective of the study is to determine whether bridge therapy improves symptom control compared with intranasal corticosteroid monotherapy. Secondary objectives include evaluating effects on nasal airflow, quality of life, nasal inflammation, and medication adherence.
- Conditions
- Persistent Allergic Rhinitis
- Being tested
- Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg, Oxymetazoline 0.05% nasal solution
- Keywords
- Allergic Rhinitis, Persistent Allergic Rhinitis, Children, Pediatric, Intranasal Corticosteroids, Oxymetazoline, Medication Adherence, PNIF, Nasal Nitric Oxide, Mometasone Furoate, Nasal Congestion, Bridge Therapy
- Medical subject headings
- Rhinitis, Allergic, Medication Adherence, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcgDrug
Mometasone furoate intranasal spray administered once daily for 4 weeks.
Oxymetazoline 0.05% nasal solutionDrug
Oxymetazoline nasal spray administered twice daily for 5 days in addition to intranasal corticosteroid therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Corticosteroid Monotherapy | Experimental | Participants received mometasone furoate intranasal spray (100 mcg once daily) for 4 weeks. Receives: Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg |
| Bridge Therapy (INS + Oxymetazoline) | Experimental | Participants received mometasone furoate intranasal spray for 4 weeks combined with oxymetazoline nasal spray during the first 5 days of treatment. Receives: Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg; Drug: Oxymetazoline 0.05% nasal solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Nasal Symptom Score (TNSS)
Evaluation of the change in Total Nasal Symptom Score (TNSS) from baseline to Week 4 between treatment groups.
Measured: Baseline and Week 4
Secondary outcomes (1)
Change in Peak Nasal Inspiratory Flow (PNIF)
Change in objective nasal airflow measured by PNIF from baseline to Week 4.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start2 Jan 2025
- Primary completion15 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Allergic RhinitisStudies 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 were randomized into two parallel treatment groups. One group received intranasal corticosteroid monotherapy, while the second group received intranasal corticosteroid therapy combined with short-term oxymetazoline during the first 5 days of treatment.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Behcet Uz Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmi Can Yüksel, MD, Dr. Behcet Uz Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593898
- Sponsor's protocol ID
- GOA-135
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to institutional policies and protection of participant confidentiality.
Publications
Gil-Mata S, Vieira RJ, Borowiack E, Sadowska E, Bognanni A, Cardoso-Fernandes A, Ferreira-Cardoso H, Castro-Teles J, Soprani J, Pinheiro L, Marques-Cruz M, Campos-Lopes M, Lourenco-Silva N, Ferreira-da-Silva R, Bedbrook A, Litynska J, Cherrez-Ojeda I, Klimek L, Pfaar O, Fernandes RM, Fiocchi AG, Giovannini M, Larenas-Linnemann DE, Pham-Thi N, Papadopoulos NG, Roberts G, Valiulis A, Yepes-Nunez JJ, Zuberbier T, Fonseca JA, Schunemann HJ, Bousquet J, Sousa-Pinto B; ARIA 2024 Guideline Panel. Intranasal Treatments for Allergic Rhinitis in Preschool- and School-Age Children: Network Meta-Analysis. J Allergy Clin Immunol Pract. 2025 Oct;13(10):2826-2837. doi: 10.1016/j.jaip.2025.07.004. Epub 2025 Jul 15.
PubMed 40675325Yuksel NC, Sancakli O, Celebi Celik F, Karkiner CS, Can D. Short-term nasal decongestant as bridge therapy with intranasal corticosteroids in children with persistent allergic rhinitis: A randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2026 Sep 29;210:113036. doi: 10.1016/j.ijporl.2026.113036. Online ahead of print.
PubMed 42843159
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Nasal Decongestant as Bridge Therapy Combined With Intranasal Corticosteroids in Children With Persistent Allergic Rhinitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07593898
- Acronym / sponsor ID
- GOA-135
- Conditions
- Persistent Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Persistent Allergic Rhinitis, Children, Pediatric, Intranasal Corticosteroids, Oxymetazoline, Medication Adherence, PNIF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Dr. Behcet Uz Children's HospitalUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 18 May 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.
Persistent allergic rhinitis in children is commonly treated with intranasal corticosteroids (INS), which are considered first-line therapy. However, the delayed onset of action of INS may reduce patient adherence and delay symptom relief. This randomized controlled study evaluates whether adding short-term oxymetazoline nasal spray during the first 5 days of INS treatment ("bridge therapy") improves clinical outcomes, nasal airflow, quality of life, nasal inflammation, and medication adherence in children with persistent allergic rhinitis.
Children aged 4-18 years with moderate-to-severe persistent allergic rhinitis were randomized into two parallel groups. One group received mometasone furoate nasal spray alone for 4 weeks, while the other group received mometasone furoate combined with oxymetazoline during the first 5 days of treatment. Clinical symptoms, Peak Nasal Inspiratory Flow (PNIF), Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Nasal Nitric Oxide (nNO), and Medication Adherence Rating Scale (MARS) scores were evaluated.
Detailed description
Allergic rhinitis is one of the most common chronic inflammatory diseases in childhood and significantly affects sleep quality, school performance, daily functioning, and quality of life. Intranasal corticosteroids (INS) are recommended as first-line therapy because of their strong anti-inflammatory effects. However, the onset of symptom relief may take several days or weeks, especially in patients with severe nasal congestion. This delayed onset may negatively affect treatment adherence and early treatment satisfaction.
Short-term use of topical nasal decongestants may provide rapid nasal patency and facilitate delivery of intranasal corticosteroids into the nasal cavity. This study investigates whether short-term oxymetazoline therapy added to the initiation of INS treatment can function as a "bridge therapy" in children with persistent allergic rhinitis.
This prospective randomized controlled study enrolled children aged 4-18 years diagnosed with moderate-to-severe persistent allergic rhinitis according to ARIA guidelines. Participants were randomized into two parallel treatment groups:
- Intranasal corticosteroid monotherapy group (mometasone furoate for 4 weeks)
- Combination therapy group (mometasone furoate for 4 weeks plus oxymetazoline during the first 5 days)
Clinical symptom severity was assessed using Total Nasal Symptom Score (TNSS). Objective nasal airflow was evaluated with Peak Nasal Inspiratory Flow (PNIF). Nasal inflammation was assessed using Nasal Nitric Oxide (nNO). Disease-specific quality of life was measured using the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), and treatment adherence was evaluated using the Medication Adherence Rating Scale (MARS).
The primary objective of the study is to determine whether bridge therapy improves symptom control compared with intranasal corticosteroid monotherapy. Secondary objectives include evaluating effects on nasal airflow, quality of life, nasal inflammation, and medication adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized into two parallel treatment groups. One group received intranasal corticosteroid monotherapy, while the second group received intranasal corticosteroid therapy combined with short-term oxymetazoline during the first 5 days of treatment.
| Arm | Type | Receives |
|---|---|---|
| Intranasal Corticosteroid Monotherapy | Experimental | Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcgParticipants received mometasone furoate intranasal spray (100 mcg once daily) for 4 weeks. |
| Bridge Therapy (INS + Oxymetazoline) | Experimental | Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg, Drug: Oxymetazoline 0.05% nasal solutionParticipants received mometasone furoate intranasal spray for 4 weeks combined with oxymetazoline nasal spray during the first 5 days of treatment. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children aged 4 to 18 years
- Diagnosis of moderate-to-severe persistent allergic rhinitis according to ARIA guidelines
- Ability to comply with study procedures
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (6 listed)
- Mechanical nasal obstruction (nasal polyposis, severe septal deviation, or adenoid hypertrophy)
- Acute upper respiratory tract infection within the previous 2 weeks
- Active smoking or significant passive smoke exposure
- Current use of allergic rhinitis medications
- Use of intranasal corticosteroids within the previous 3 months
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 (MF) Metered Dose Inhaler (MDI), 100 mcgMometasone furoate intranasal spray administered once daily for 4 weeks. | Drug | Bridge Therapy (INS + Oxymetazoline), Intranasal Corticosteroid Monotherapy |
| Oxymetazoline 0.05% nasal solutionOxymetazoline nasal spray administered twice daily for 5 days in addition to intranasal corticosteroid therapy. | Drug | Bridge Therapy (INS + Oxymetazoline) |
Primary outcome
Change in Total Nasal Symptom Score (TNSS)
Time frame: Baseline and Week 4
Evaluation of the change in Total Nasal Symptom Score (TNSS) from baseline to Week 4 between treatment groups.
1 secondary outcome
Change in Peak Nasal Inspiratory Flow (PNIF)
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 40675325Gil-Mata S, Vieira RJ, Borowiack E, Sadowska E, Bognanni A, Cardoso-Fernandes A, Ferreira-Cardoso H, Castro-Teles J, Soprani J, Pinheiro L, Marques-Cruz M, Campos-Lopes M, Lourenco-Silva N, Ferreira-da-Silva R, Bedbrook A, Litynska J, Cherrez-Ojeda I, Klimek L, Pfaar O, Fernandes RM, Fiocchi AG, Giovannini M, Larenas-Linnemann DE, Pham-Thi N, Papadopoulos NG, Roberts G, Valiulis A, Yepes-Nunez JJ, Zuberbier T, Fonseca JA, Schunemann HJ, Bousquet J, Sousa-Pinto B; ARIA 2024 Guideline Panel. Intranasal Treatments for Allergic Rhinitis in Preschool- and School-Age Children: Network Meta-Analysis. J Allergy Clin Immunol Pract. 2025 Oct;13(10):2826-2837. doi: 10.1016/j.jaip.2025.07.004. Epub 2025 Jul 15.
- Derived from this study: PubMed 42843159Yuksel NC, Sancakli O, Celebi Celik F, Karkiner CS, Can D. Short-term nasal decongestant as bridge therapy with intranasal corticosteroids in children with persistent allergic rhinitis: A randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2026 Sep 29;210:113036. doi: 10.1016/j.ijporl.2026.113036. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to institutional policies and protection of 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (MF) Metered Dose Inhaler (MDI), 100 mcg and Oxymetazoline 0.05% nasal solution in people with Persistent Allergic Rhinitis, run by Dr. Behcet Uz Children's Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 18 May 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Nasal Symptom Score (TNSS) (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07593898, which also lists 2 linked publications.
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 18 May 2026.