| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
- healthy volunteers,
- moderate and severe persistent asthmatic patients,
- moderate and severe COPD patients
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| 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 |
| The primary objective of this study is to evaluate the difference in Inspiratory Capacity (IC) measured by spirometry at rest while breathing each Helium/Oxygen mixture (He/O2 78:22 and He/O2 65:35) compared to medical air in healthy volunteers, in moderate and severe persistent asthmatic patients and in moderate and severe COPD patients, separately. |
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| E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are:
-to measure additional pulmonary function parameters during light bicycling exercise while breathing each Helium/Oxygen mixture compared to medical air,
-to assess the safety of the administration of both Helium/Oxygen mixtures in healthy volunteers and in asthma and COPD patients.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
The criteria for inclusion are:
All subjects/patients:
Male or female aged ≥ 18 and 80 years old,
Willing and able to complete the requirements of this study including the signature of the written informed consent,
Able to complete the study in 5 working days or less,
Able to perform pulmonary function tests
Healthy volunteers:
Never smoker or subject who stopped smoking at least 6 months before selection (strictly less than 10 pack-years),
Having pulmonary function tests within the normal range (according to predicted values for age, sex and height as referenced in “ATS/ERS Task force : standardisation of lung function testing” c.f. Euro respiratory journal 2005;26:948-968)
Patients with moderate / severe persistent asthma:
Documented clinical diagnosis of moderate or severe persistent asthma (according to GINA 2006 guidelines, see Appendix 12.E),
Never smoker or patient who stopped smoking at least 6 months before selection (strictly less than 10 pack-years),
Stable asthma in the 4 weeks prior to selection as evidenced by no change in asthma medication, no treatment for asthma in an emergency, acute care setting and no admission to hospital for acute asthma,
Reversibility with 400 μg salbutamol ≥ 12% increase FEV1 (+ 200 mL) compared to baseline. Should the investigator be able to provide historical information of patient’s response to salbutamol within the last 1 year before selection, then the bronchial reversibility test is not to be carried out,
Patients with moderate / severe COPD:
Aged ≥ 45 and 80 years old,
Documented clinical diagnosis of moderate or severe COPD (according to GOLD 2006 guidelines, see Appendix 12.F),
With a smoking history of 10 pack-years or more,
Stable COPD in the 4 weeks prior to selection as evidenced by no change in COPD medication, no treatment for COPD in an emergency, acute care setting and no admission to hospital for COPD exacerbation.
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| E.4 | Principal exclusion criteria |
The criteria for exclusion are:
Obese subject/patient having a Body Mass Index (BMI) > 30,
Past or present respiratory disease including being free from the common cold and rhinitis for at least 4 weeks before selection except asthma for asthmatic patients and COPD for COPD patients,
Daily need for 12 hours or more of long term oxygenotherapy,
Pregnant or lactating woman, Female patients: pregnant, positive pregnancy test, lactating mother or lack of efficient contraception (according to CPMP/ICH 286/95 note 3 ). Postmenopausal women < 1 year must have efficient contraception. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner. For patients using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
Any contra-indication to perform pulmonary function tests or light exercise,
Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders which may interfere with the study procedures,
Known sensitivity to the investigational products,
Drug abuse or psychic disorders resulting in an inability to fully understand the requirements of the study,
Legal status which prohibits informed consent,
Participation in any interventional clinical trial within 30 days prior to selection (Visit 0) or current participation in another investigational product trial.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy criterion is the Inspiratory Capacity (IC) measured during spirometry at rest while breathing each of the three gas mixtures evaluated (Helium/Oxygen 78:22, Helium/Oxygen 65:35 and medical air). |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Information not present in EudraCT |
| E.6.4 | Safety | Information not present in EudraCT |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Yes |
| 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 | Information not present in EudraCT |
| E.8.1.3 | Single blind | Yes |
| E.8.1.4 | Double blind | Information not present in EudraCT |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| 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 | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| 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
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| 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 | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
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