A Nasal Allergen Challenge (NAC) study to evaluate the effects of SMP-028 on the release of inflammatory mediators in subjects with allergic rhinitis out of season

An exploratory, randomised, double-blind, placebo-controlled, 14-day, three-way crossover study, followed by an open label 1 day period when subjects will be dosed with intranasal fluticasone, nasal allergen challenge (NAC) study to evaluate the effects of SMP-028 on the release of inflammatory mediators after NAC with timothy grass pollen in subjects with allergic rhinitis out of season

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN36587529

Enrollment

Registered

2009-11-11

Start date

2009-11-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis Respiratory

Interventions

Subjects will be randomly assigned to one of two treatment groups. Within each group the subjects will receive two oral dosing regimens of SMP-028 and placebo. Group A: SMP-028 40 mg once daily, SMP-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female (non-child bearing potential) subjects aged 18 to 55 years old with atopy to timothy grass pollen 2. Asymptomatic as characterised by a normal appearing nasal mucosa with no active allergic rhinitis at screening and on day 1 of each treatment period 3. An eosinophilic nasal response after NAC with timothy grass pollen at the screening visit 4. Body mass index (BMI) within the range 19.0 - 32.0 kg/m^2 (inclusive) 5. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) greater than 90% of predicted at screening

Exclusion criteria

Exclusion criteria: 1. Past or present disease which, as judged by the Investigator, may affect the outcome of this study 2. Past or present nasal condition which may affect the outcome of the study 3. Bacterial or viral infection of the upper/lower airways, sinus, or ear 4. History of being unable to tolerate or complete NAC tests 5. Subject is undergoing or has undergone desensitisation therapy

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic endpoints: 1. Post-NAC nasal filter paper levels of chemical mediators and cytokines 2. Nasal lavage fluid eosinophil, neutrophil and monocyte counts (number/mm^3) Clinical and PK endpoints: 3. Total nasal symptom score after NAC 4. Multiple dose PK of SMP-028 Safety endpoints: 5. Adverse events 6. Standard laboratory safety tests 7. Vital signs 8. Physical examinations 9. 12-lead electrocardiogram (ECG) 10. Hormone laboratory tests All endpoints are followed up to day 14 apart from safety which will be followed up until 10 days +/- 3 days after the last treatment period.	—

Measure

Time frame

Pharmacodynamic endpoints: 1. Post-NAC nasal filter paper levels of chemical mediators and cytokines 2. Nasal lavage fluid eosinophil, neutrophil and monocyte counts (number/mm^3) Clinical and PK endpoints: 3. Total nasal symptom score after NAC 4. Multiple dose PK of SMP-028 Safety endpoints: 5. Adverse events 6. Standard laboratory safety tests 7. Vital signs 8. Physical examinations 9. 12-lead electrocardiogram (ECG) 10. Hormone laboratory tests All endpoints are followed up to day 14 apart from safety which will be followed up until 10 days +/- 3 days after the last treatment period.

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Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026