Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
D4050092
Study information
Scientific title
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
Acronym
NAC SMP-028
Study hypothesis
Primary:
To assess the pharmacodynamic (PD) response to a standardised nasal allergen challenge (NAC) with timothy grass pollen following multiple doses of SMP-028 in subjects with allergic rhinitis out of season.
Secondary:
1. To evaluate the effects of multiple doses of SMP-028 on allergic rhinitis symptoms after NAC
2. To evaluate the safety and tolerability of 14 days of dosing of SMP-028
3. To evaluate the multiple dose pharmacokinetics (PK) of SMP-028
Ethics approval
Added 21/05/10:
The Royal Free Hospital & Medical School Research Ethics Committee approved on the 17th of December 2009 (ref: D4050092 [NAC])
Study design
Exploratory randomised double-blind placebo-controlled crossover study, followed by an open label 1 day period
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Allergic rhinitis
Intervention
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-028 160 mg once daily and placebo once daily
Group B: SMP-028 10 mg twice daily, SMP-028 80 mg twice daily and placebo twice daily
On Day 14: Only a single dose will be administered in the morning. Any remaining dose for that day will not be taken by the subject (e.g. Group B subjects).
Intervention type
Drug
Phase
Not Specified
Drug names
SMP-028
Primary outcome measures
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.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2009
Overall trial end date
01/04/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Approximately 40 completed subjects (two groups of 20 subjects)
Participant 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
Recruitment start date
01/11/2009
Recruitment end date
01/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Respiratory Clinical Trials Ltd (TCT)
London
W1G 8HU
United Kingdom
Sponsor information
Organisation
Dainippon Sumitomo Pharma Europe Ltd (UK)
Sponsor details
c/o Ms Eiling Tan
1st Floor
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dainippon Sumitomo Pharma Co. Ltd (Japan)
Alternative name(s)
Dainippon Sumitomo Pharma Co., Ltd.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Japan
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary