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 measure
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 (if study stopped)
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
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
For-profit companies (industry)
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
Basic results (scientific)
Publication list