Phase I study to assess the safety and tolerability of inhaled interferon-beta (IFN-beta1a) in controlled asthmatic male and female subjects
- Conditions
- AsthmaRespiratory
- Registration Number
- ISRCTN83107787
- Lead Sponsor
- Synairgen Research Limited (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
To be eligible for inclusion into this study, each subject must fulfil the following criteria:
1. Diagnosis of controlled asthma requiring regular inhaled corticosteroids (ICS). Subjects must have been taking the same dose of ICS regularly for six weeks prior to Screening Visit one.
2. Forced expiratory volume in one second (FEV1) is equal to or greater than 80% predicted and diffusing capacity of the lung for carbon monoxide (DLCO/TLCO) equal to or greater than 80% predicted (pre-bronchodilator)
3. Presence of bronchial hyperresponsiveness as measured by a methacholine challenge which results in a provocative concentration causing a 20% fall in FEV1 (PC20) equal to or less than 16 mg/ml
4. Stable asthma, indicated by asthma symptoms and bronchodilator usage equal to or less than three times a week when needed to relieve symptoms. In addition to this, bronchodilator usage equal to or less than once a day if taken as a preventative prior to exercise will be allowed.
5. Male or female aged 18 to 55 years
6. Non-smoker or an ex-smoker who has stopped smoking for more than one year and has a smoking history of less than 10 pack-years
7. Written informed consent
8. Vital signs in the following normal range:
8.1. Oral body temperature: 35.0 - 37.5°C
8.2. Blood pressure:
8.2.1. After at least 3 minutes of rest, measured in the supine position:
Systolic blood pressure: 90 - 140 mmHg
Diastolic blood pressure: 50 - 90 mmHg
8.2.2. Then, after 3 minutes standing:
Systolic blood pressure: no more than a 20 mmHg drop
Diastolic blood pressure: no more than 10 mmHg drop
8.3. Pulse rate: after at least 3 minutes of rest, measured in supine position: 40 - 90 beats per minute (bpm)
8.4. Pulse oximetry greater then or equal to 95%
9. Motivation to complete all study visits, the ability to communicate well with the Investigator and be capable of understanding the nature of the research and its treatment including its risks and benefits
Any condition, including findings in the medical history or in the pre-study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the subject into the study or that could interfere with the study objectives, conduct or evaluation. In particular:
1. Use of long acting bronchodilators
2. A change in dose of asthma medication during the past six weeks
3. Any clinically significant abnormality in the results of the pre-study safety laboratory tests
4. History of any lung disease other than asthma
5. Current participation in another clinical trial or participation in a clinical trial where the subject has received a dose of the test product (investigational medicinal product [IMP]) within 12 weeks prior to entry into the study (for small molecules) and within 6 months prior to entry into the study (for biologicals)
6. Any clinically significant abnormality on the 12 lead resting electrocardiogram
7. History or presence of hypertension or other significant cardiovascular abnormality
8. Occurrence of any acute infection or disease within the last six weeks prior to screening
9. History of asthma exacerbation and/or upper/lower respiratory tract infection within six weeks prior to screening
10. History of hypersensitivity to natural or recombinant interferon-beta or to any of the drug preparation excipients
11. History of severe depressive disorders and/or suicidal ideation
12. History of liver disease or liver blood test abnormalities other than Gilbert's syndrome
13. History of epilepsy or seizures
14. Definite or suspected personal history of adverse drug reaction or hypersensitivity to drugs with a similar chemical structure to interferon
15. History or presence of drug or alcohol abuse
16. Loss or donation of more than 400 ml of blood within 12 weeks prior to entry into the study
17. Subjects who have taken any prescription drugs within 6 weeks, other than medication for the treatment of asthma and drugs used for the treatment of atopic dermatitis, atopic rhinitis and other allergic conditions. All other concomitant medications will be at the discretion of the Investigator.
18. Subjects who have taken over-the-counter medication, with the exception of multi-vitamins and paracetamol, within 1 week before drug administration. All other concomitant medications will be allowed at the discretion of the Investigator.
19. Subjects will undergo training during the screening phase to ensure their ability to use the I-neb® device. If subjects do not show sufficient proficiency in the use of the device, they will not be eligible for inclusion in the study.
20. Pregnancy either current or planned over the next 12 weeks. For those who are sexually active precautions are to be advised to both male and female subjects to avoid pregnancy during the trial and follow-up period. These precautions include pregnancy testing at screening, baseline and follow up, as well as the use of a highly effective method of birth control (i.e. the oral contraceptive pill or IUD and the use of condoms) or after surgical sterilisation (i.e. hysterectomy). Continued testing and monitoring will take place during the trial if required.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method