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

ISRCTN	ISRCTN36587529
DOI	https://doi.org/10.1186/ISRCTN36587529
Secondary identifying numbers	D4050092

Submission date: 21/09/2009
Registration date: 11/11/2009
Last edited: 21/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brian Leaker
Scientific

Respiratory Clinical Trials Ltd (TCT)
Heart Lung Centre
Queen Anne Street Medical Centre
18-20 Queen Anne Street
London
W1G 8HU
United Kingdom

Study information

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
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	NAC SMP-028
Study objectives	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(s)	Added 21/05/10: The Royal Free Hospital & Medical School Research Ethics Committee approved on the 17th of December 2009 (ref: D4050092 [NAC])
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	SMP-028
Primary outcome measure	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 study start date	01/11/2009
Completion date	01/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	Both
Target number of participants	Approximately 40 completed subjects (two groups of 20 subjects)
Key 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
Key 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
Date of first enrolment	01/11/2009
Date of final enrolment	01/04/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Respiratory Clinical Trials Ltd (TCT)

London
W1G 8HU
United Kingdom

Sponsor information

Dainippon Sumitomo Pharma Europe Ltd (UK)
Industry

c/o Ms Eiling Tan
1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom

Website	http://www.ds-pharma.co.jp/english
"ROR"	https://ror.org/03sh4z743

Funders

Funder type

Industry

Dainippon Sumitomo Pharma Co. Ltd (Japan)
Private sector organisation / For-profit companies (industry)

Alternative name(s): Dainippon Sumitomo Pharma Co., Ltd.
Location: Japan

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

21/07/2016: No publications found, verifying study status with principal investigator