E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prevention or attenuation of asthma symptoms caused by respiratory viruses |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the superiority of inhaled SNG001 compared to placebo administered to asthmatic subjects after the onset of a respiratory viral infection for the prevention or attenuation of asthma symptoms caused by respiratory viruses in the modified intention to treat (mITT) population as measured by change from Baseline to Day 8 in the Shortened-Asthma Control Questionnaire (symptoms plus short-acting β2 agonist [Juniper et al, 2005]).
|
|
E.2.2 | Secondary objectives of the trial |
a,b,c,d,e,f) To evaluate the superiority of SNG001 compared with placebo
a) - in the mITT pop as measured by peak score of the Asthma Index in the 14 day period following first administration of study drug
b) - in the per protocol (PP) pop as measured by change from Baseline to Day 8 in the Shortened-ACQ.
c) in the PP pop as measured by peak score of the AI in the 14 day period following first administration of study drug
d) - as measured by the proportion of subjects experiencing a severe exacerbation.
e) - for the prevention or attenuation of decreases in lung function (AUC FEV1 and PEFR) caused by respiratory viruses.
f) - when administered to asthmatic subjects on viral load on Days 4 and 7 in sputum.
g) To evaluate the safety.
h) To compare the frequency of use of concomitant medications compared to placebo.
i) To gain information on the PK/PD profiles of SNG001 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
PRE-TREATMENT PHASE:
1. Male or female aged 18 to 65 years of age at the time of screening.
2. Symptoms of asthma for at least 2 years prior to the Screening Visit, confirmed by a medical history and:
- ≥12% and 200mL bronchodilator reversibility at screening or documented in the past, OR,
- evidence of bronchial hyper-responsiveness at screening or documented in the past, OR,
- a documented hospital admission (including an Accident and Emergency admission) for asthma since the age of 18, OR
- documented evidence that they have attended their GP surgery, out-of-hours clinic (or alternative health care provider) for worsening of asthma symptoms, since the age of 18
3. Must answer ‘Yes’ to the question “Does a cold make your asthma worse?”
4. To have had at least one asthma exacerbation suspected to have been caused by a respiratory virus in the last 24 months which required the use of oral steroids and/or additional treatment with antibiotics on one or more occasion.
5. Must be taking regular inhaled corticosteroids.
6. Pre-bronchodilator FEV1 ≥ 40 % predicted at screening.
7. Post-bronchodilator FEV1 ≥ 50 % predicted at screening.
8. Provide written informed consent.
9. Females of childbearing potential must be using a medically acceptable adequate form of birth control and agree to maintain this usage throughout the duration of and four weeks post the Treatment Phase of the study.
10. Motivation (in the Investigator’s opinion) 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.
TREATMENT PHASE:
Subjects must meet all of the following Inclusion Criteria to be eligible for enrolment into the Treatment Phase of the study:
1. The subject is currently experiencing respiratory virus symptoms that have developed within the last 24 hours, which may be either:
cold symptoms (specifically a blocked or runny nose, and a sore or scratchy throat)
or
influenza-like illness (fever >37.8C plus two of the following symptoms: headache, cough, sore throat, and myalgia).
2. The subject thinks that they have a cold or influenza.
3. The subject has continued to use inhaled steroids (as per usual for this subject) since the Screening Visit.
4. The subject has a post-bronchodilator FEV1 ≥35% predicted.
5. The subject is motivated (in the Investigator’s opinion) and available to complete all study visits, and has 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.
6. Females of childbearing potential must be using an effective form of birth control and agree to maintain this usage throughout the duration of and four weeks post the Treatment Phase of the study.
|
|
E.4 | Principal exclusion criteria |
PRE-TREATMENT PHASE:
1. Any condition, including findings in the medical history or in the pre-study assessments that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation.
2. History of lung disease other than asthma.
3. Current smokers (or ex-smokers who have given up smoking in the last 12 months).
4. Ex-smokers with >10 pack year smoking history.
5. Current participation in another clinical trial or participation in a clinical trial where the subject has received a dose of a test 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. If the subject has had a recent asthma exacerbation and/or upper or lower respiratory tract infection or exhibits signs and/or symptoms of a respiratory illness, there should be at least 4 weeks between the resolution of the illness and the subject entering the study.
7. Subjects with significant underlying medical conditions that could impact interpretation of results should be excluded (e.g. infection, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease including arrhythmias, endocrinological or gastrointestinal disease) within the previous 3 months.
8. History of hypersensitivity to natural or recombinant IFN-β or to any of the drug preparation excipients.
9. Significant history of depressive disorder or suicidal ideation.
10. History of epilepsy or seizures after the age of 5 years.
11. Recent history of drug or alcohol abuse.
12. Subjects who have hepatic serum enzyme levels ≥ 2.5 times the normal range.
13. Female who is breast-feeding, pregnant or intends to become pregnant.
TREATMENT PHASE:
1. The subject had an asthma exacerbation and/or upper or lower respiratory tract infection in the past 4 weeks.
2. The subject has a pre-bronchodilator FEV1 <30% predicted.
3. The subject has been diagnosed with any further lung disease since the Screening Visit.
4. The subject has already started taking, or has increased their oral steroids for an
asthma exacerbation.
5. The subject has any condition, including findings in the medical history which 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 during the Treatment Phase.
6. Since the Screening Visit, the subject has taken or started to take any medication other than their asthma medications that the Investigator deems as not suitable for inclusion into the Treatment Phase.
7. The subject is breast feeding or pregnant. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is defined as the comparion of the mean change from Baseline to Day 8 of the Shortened - ACQ in the mITT population.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
compare frequency of use of concomitant medications |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Provided in the protocol. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |