Condition category
Respiratory
Date applied
21/09/2009
Date assigned
11/11/2009
Last edited
21/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Brian Leaker

ORCID ID

Contact details

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

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

http://www.ds-pharma.co.jp/english

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

Publication citations

Additional files

Editorial Notes

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