E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Mild to moderate persistent asthma, steroid-free patients | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10003553 | E.1.2 | Term | Asthma | |
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 assess the efficacy and safety of multiple doses of QAV680 (500 mg BID over 14 days) compared to placebo in mild to moderate persistent steroid free asthma patients | |
E.2.2 | Secondary objectives of the trial | • To assess the pharmacokinetics of multiple doses of QAV680 in asthma patients. • To assess the pharmacodynamic effect of multiple doses of QAV680 on exhaled NO in asthma patients. • To assess the effect of QAV680 on asthma control using assessments such as Asthma Control Questionnaire (ACQ) score, FEV1 variability data captured by PIKO-1 home monitoring device and the extent of inhaled salbutamol use as rescue medication. | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | 1. Male and female patients aged 18 to 65 years with symptomatic mild to moderate persistent asthma for ≥ 6 months 2. Patients should be steroid naive or off steroids and chromoglycate (by any route) for at least 4 weeks before randomisation. Only use of short-acting β2-agonists is permissible as rescue medication. 3. Patients should have pre-bronchodilator FEV1 ≥60% predicted with ≥12% or 200 mL improvement post short acting β2-agonist (200µg inhaled Salbutamol). • Patients who are NOT on ICS during screening need to demonstrate reversibility during screening visit • Patients who are on steroids need to demonstrate reversibility during the first baseline AFTER their steroid-withdrawal 4. Women must be postmenopausal or surgically sterilized at the time of participation as defined in the protocol. 5. Male subjects must be using a two acceptable methods of contraception as defined in the protocol up to the Study Completion visit and refrain from fathering a child in the 3 months following the last study drug administration. 6. Subjects must weigh at least 45 kg and have a body mass index (BMI) within the range of 20 to 30 kg/m2. 7. Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent. | |
E.4 | Principal exclusion criteria | 1. Smokers (defined as history of smoking in the previous 2 months) 2. Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing other than short acting inhaled beta-agonists and paracetamol is acceptable but must be documented in the Concomitant CRF. 3. Participation in any clinical investigation within 4 weeks prior to initial dosing. 4. Donation or loss of 400 ml or more of blood within 8) weeks prior to initial dosing. Hemoglobin levels below 12.0 g/dl at screening. 5. Significant illness within 2 weeks prior to initial dosing. 6. Patients with positive stool examination at screening for helminthic, ova or parasitic infections. 7. Past medical history of clinically significant ECG abnormalities, or recent history of hypertension or autonomic dysfunction 8. Recent history (within past three months) of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures. 9. Use of theophylline or long acting β2 agonists in the last 2 weeks prior to dosing 10. Pregnant or lactating women. 11. Any disease or illness, other than asthma, that may require the use of systemic corticosteroids during the study period. 12. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication. Patients with other serious underlying diseases as defined in protocol. 13. History of multiple allergies to drugs or allergy to the investigational compound/compound class being used in this study. 17. Vulnerable patients (e.g. patients kept in detention) ---REFER TO STUDY PROTOCOL FOR FULL LIST OF EXCLUSION CRITERIA--- | |
E.5 End points |
E.5.1 | Primary end point(s) | Trough FEV1 on Day 15 of each treatment period | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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 | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description | Third period with open-label fluticasone propionate | |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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 | 2 |
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 | No |
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 | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 15 |