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 |
| Secondary identifying numbers | D4050169 |
- 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
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
| Study design | Exploratory randomised double-blind placebo-controlled two-way crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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, 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 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 | 65 Years |
| Sex | Both |
| Target number of participants | Approximately 24 subjects in order to ensure 20 completed subjects |
| 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
- England
- United Kingdom
Study participating centre
Respiratory Clinical Trials Ltd (RCT)
London
W1G 8HU
United Kingdom
W1G 8HU
United Kingdom
Sponsor information
Dainippon Sumitomo Pharma Europe Ltd (UK)
Industry
Industry
1st Floor, Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
"ROR" |
https://ror.org/03sh4z743 |
|---|
Funders
Funder type
Industry
Dainippon Sumitomo Pharma Co. Ltd (Japan)
Private sector organisation / For-profit companies (industry)
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
