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 (RCT)
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

D4050169

Study information

Scientific title

An exploratory, randomised, double-blind, placebo controlled, 14 day, two-way crossover, Inhaled Allergen Challenge (IAC) study to evaluate the effects of SMP-028 in subjects with mild to moderate asthma

Acronym

IAC SMP-028

Study hypothesis

Primary:
To evaluate the effect on the late asthmatic response (LAR) to Inhaled Allergen Challenge in mild to moderate asthmatic subjects.

Secondary:
1. To evaluate the effect on the early asthmatic response (EAR), pharmacodynamics and lung function to Inhaled Allergen Challenge in mild to moderate asthmatic subjects
2. To evaluate the effect on bronchial hyper-reactivity as measured by adenosine monophosphate (AMP) challenge
3. To assess the safety and tolerability of treatment with repeat doses of SMP-028 in mild to moderate asthmatic subjects
4. To evaluate the multiple dose pharmacokinetics of SMP-028 and metabolites in subjects with mild to moderate asthma

Ethics approval

Added 21/05/10:
The Royal Free Hospital & Medical School Research Ethics Committee approved on the 1st of October 2009 (ref: D4050169 [IAC])

Study design

Exploratory randomised double-blind placebo-controlled two-way crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

On Days 1 - 13, the dose of SMP-028 will be 80 mg twice a day or placebo. A single morning dose of 80 mg SMP-028 or placebo will be taken on Day 14.

Intervention type

Drug

Phase

Not Specified

Drug names

SMP-028

Primary outcome measures

Mean baseline-corrected area under the forced expiratory volume in 1 second (FEV1) reduction curve from 4 to 10 hours after allergen challenge.

Secondary outcome measures

1. Early Asthmatic Response: FEV1
2. Exhaled NO
3. AMP PC20
4. Induced sputum cell counts
5. induced sputum inflammatory mediators
6. Adverse events
7. Laboratory safety tests
8. Vital signs
9. Physical examinations
10. 12-lead ECGs (electrocardiograms)
11. Pharmacokinetics of SMP-028 and its metabolites

Measured on Day 13/14 as appropriate. In addition, safety is followed up until 10 days +/- 3 days after the last dose on Day 14 of Period 2.

Overall trial start date

01/11/2009

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female (of non childbearing potential) subjects aged between 18 and 65 years who have documented history of bronchial asthma
2. Demonstration of a positive wheal reaction to at least 1 of 3 allergens (house dust mite, grass pollen, cat hair and dander) on skin prick testing
3. Screening allergen challenge demonstrating that the subject experiences both an early and late asthmatic response.
4. Body mass index (BMI) within the range 19.0 - 32.0 kg/m^2 (inclusive)
5. Sensitivity to AMP with a provocative concentration of AMP

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Approximately 24 subjects in order to ensure 20 completed subjects

Participant exclusion criteria

1. Past or present disease which, as judged by the Investigator, may affect the outcome of this study
2. Subject has known history of uncontrolled hypertension or is hypertensive at the Screening visit
3. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study drug
4. Symptomatic allergic rhinitis
5. History of life-threatening asthma

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 (RCT)
London
W1G 8HU
United Kingdom

Sponsor information

Organisation

Dainippon Sumitomo Pharma Europe Ltd (UK)

Sponsor details

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

Publication citations

Additional files

Editorial Notes

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