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Randomized study of ketotifen nasal spray (0.025% and 0.050%) versus sodium cromoglicate nasal spray in patients with rhinitis

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What is this study about?

People with Rhinitis experience a runny or blocked nose, sneezing and itchy eyes caused by inflammation of the nasal passages. This study looks at three types of nasal spray: two different strengths of a spray containing ketotifen (a medication that helps reduce allergic reactions), a spray containing sodium cromoglicate (another allergy‑relief medicine), and a placebo spray that does not contain an active drug.

The purpose of the trial is to explore how well the new ketotifen sprays work and how well they are tolerated compared with the existing cromoglicate spray and the placebo. Participants will use the assigned spray in each nostril every day for up to 12 weeks. They will have a visit before starting treatment, a check‑in after about 4 weeks, and a final visit at 12 weeks to see how symptoms have changed.

Symptoms are measured using a simple rating line called a VAS score, where a person marks how severe their nose problems feel from “no trouble” to “worst possible.” Changes in this score and other symptom counts help show whether the spray makes a noticeable difference. All procedures are designed to be safe and easy to follow.

1 baseline visit and randomization

you attend the first clinic visit after joining the study. the study staff confirm that you meet the eligibility criteria for rhinitis and record your initial symptom scores using a visual analog scale (vas), the intranasal total nasal symptom score (itnss), and the allergic rhinitis score (ars).

based on a computer-generated random list, you are assigned to one of four groups: ketotifen 0.025% nasal spray, ketotifen 0.050% nasal spray, sodium cromoglicate nasal spray, or placebo nasal spray. you receive the assigned spray together with written instructions on how to use it.

2 start of treatment

you begin using the nasal spray immediately after the baseline visit. the spray is for nasal use only. the ketotifen sprays contain either 0.025% (0.25 mg/ml) or 0.050% (0.50 mg/ml) ketotifen, each delivering a dose of 4 mg/ml. the sodium cromoglicate spray contains 2% sodium cromoglicate, corresponding to 6 mg/ml. the placebo spray contains no active ingredient.

you follow the dosing schedule provided by the study staff, which typically involves applying the spray once or twice daily for a total treatment period of twelve weeks.

3 week 4 follow‑up visit

four weeks after starting the spray, you return to the clinic for a follow‑up visit. the study staff again measure your symptom scores with vas, itnss, and ars to assess any changes from baseline.

the medication you are using is checked to ensure correct use, and you continue the same spray for the remaining treatment period.

4 week 12 final visit and end of treatment

twelve weeks after the baseline visit, you attend the final clinic visit. the same symptom scores (vas, itnss, ars) are recorded to compare with the baseline and week‑4 results.

the study medication is stopped, and any remaining spray is returned to the study staff. you receive a summary of your participation and are thanked for completing the trial.

Who Can Join the Study?

  • Male or female, any race, and at least 12 years old.
  • Have a diagnosis of rhinitis (allergic or non‑allergic), which can be chronic (lasting 12 weeks or more) or not chronic.
  • Show at least one symptom of rhinitis right now, such as a blocked nose, runny nose, sneezing, or itching.
  • If you are a woman, you must be postmenopausal (no periods for more than 12 months), have had surgical sterilization, or be using an effective birth‑control method. Effective methods include combined hormonal pills, patches or rings; progestogen‑only pills, implants or injections; an intrauterine device or hormone‑releasing system; permanent tubal blockage; a partner who has had a vasectomy; or agreed sexual abstinence.
  • Be able to understand what the trial involves and agree to return for the required follow‑up visits.
  • Be willing to sign a voluntary written informed consent form and a data‑protection declaration before any study procedures begin.

Who Cannot Join the Study?

  • You have received a long‑acting steroid injection (depot corticosteroids) within the last 8 weeks, or taken the study drug (ketotifen) within the last 2 weeks, or used short‑acting steroids (taken by mouth, injection, or spray) or allergy medicines such as sodium cromoglycate or nedocromil sodium within the last week.
  • You are currently taking tricyclic antidepressants, which are a type of medicine for depression.
  • Any whole‑body (systemic) medicine that could change your nose symptoms has been changed in the past 30 days.
  • You have a known allergy or poor tolerance to any part of the study drug (IMP – investigational medicinal product) used in this trial.
  • You are pregnant, breastfeeding, or could become pregnant and are not using a highly effective contraceptive method (very reliable birth control).
  • You are currently part of another clinical trial, or you finished another trial less than 30 days ago.
  • You are unwilling or unable to follow the study’s procedures.
  • You do not agree to let the study keep and share your de‑identified medical information for research purposes.
  • You are legally unable to make decisions for yourself (legally incapacitated).
  • You are legally detained in an official institution (such as a prison or secured psychiatric facility).
  • You have received anti‑allergy immunotherapy (a treatment that gradually desensitises you to allergens) in the past two years or are still receiving it.
  • You have asthma that requires regular use of inhaled or whole‑body (systemic) steroids; using inhaled bronchodilators (medicines that open the airways) is allowed.
  • You have had a sinus or upper‑airway infection that needed antibiotics in the past 2 weeks, or a common cold (viral upper respiratory infection (URI)) in the past 7 days.
  • You have a significant disease of metabolism, blood, liver (hepatic), nerves (neurologic), mind (psychiatric), kidneys (renal), or other major organ that could put you at risk or affect the study results.
  • You have recent nasal ulcers, erosion of the lining inside the nose, or nose injury that could interfere with the study.
  • You had nasal surgery (operations on the nose) within the past 6 months.
  • You have structural problems in the nose, such as large non‑cancerous growths (nasal polyps) or a severely crooked nasal wall (septal deviation), that block airflow.
  • You are dependent on nasal, oral, or eye decongestants (medicines that shrink swollen nasal passages) or on nasal spray antihistamines (topical antihistamines) that relieve allergies.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
General University Hospital Of Larissa Larissa Greece
Asklepieion Voulas General Hospital Voula Greece
General Hospital Of Larissa Koutlibaneio And Triantafylleio Larissa Greece
Exdhafhwvh Knpoxcy Sxyzqtp Thessaloniki Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Not yet recruiting
01.05.2026

Trial locations

Investigated Drugs:

Ketotifen nasal spray is a medication that is sprayed into the nose to help relieve symptoms of rhinitis, such as runny nose, sneezing, and nasal itching. In this trial, two different strengths of the spray are being tested to see which works better and is more comfortable for patients. The spray works by stabilizing certain cells in the nose that release substances causing allergy symptoms, which can reduce the overall allergic response.

Sodium cromoglicate nasal spray (known as cromoglycate) is an existing nasal spray that is also used to treat rhinitis symptoms. In the study, it is used as a comparison to the ketotifen sprays to see how well the new formulation works relative to this established treatment. The spray helps prevent the release of chemicals that cause inflammation and allergy symptoms in the nasal passages.

Rhinitis – Rhinitis is an inflammation of the lining of the nose that leads to a runny or blocked nose, sneezing, and itching. It often starts after exposure to allergens, irritants, or infections and may appear as a single episode or in repeated bouts. As the condition continues, the nasal lining can become more sensitive, making symptoms appear more easily and last longer. Changes in seasons or ongoing exposure to triggers can cause the severity of symptoms to vary over time. The condition mainly affects comfort and daily activities without implying serious health risks.

Trial ID:
2026-525419-16-00
Protocol code:
BECRO/PS/NASUS
Trial Phase:
Therapeutic exploratory (Phase II)

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