An Inhaled Allergen Challenge (IAC) study to evaluate the effects of SMP-028 in subjects with mild to moderate asthma

ISRCTN	ISRCTN29389604
DOI	https://doi.org/10.1186/ISRCTN29389604
Protocol serial number	D4050169
Sponsor	Dainippon Sumitomo Pharma Europe Ltd (UK)
Funder	Dainippon Sumitomo Pharma Co. Ltd (Japan)

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 (RCT)
Heart Lung Centre
Queen Anne Street Medical Centre
18-20 Queen Anne Street
London
W1G 8HU
United Kingdom

Study information

Primary study design	Interventional
Study design	Exploratory randomised double-blind placebo-controlled two-way crossover trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	IAC SMP-028
Study objectives	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(s)	Added 21/05/10: The Royal Free Hospital & Medical School Research Ethics Committee approved on the 1st of October 2009 (ref: D4050169 [IAC])
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	SMP-028
Primary outcome measure(s)	Mean baseline-corrected area under the forced expiratory volume in 1 second (FEV1) reduction curve from 4 to 10 hours after allergen challenge.
Key secondary outcome measure(s)	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.
Completion date	01/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	24
Key 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
Key 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
Date of first enrolment	01/11/2009
Date of final enrolment	01/04/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Respiratory Clinical Trials Ltd (RCT)

London
W1G 8HU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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