E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Obstructive Pulmonary Disease (COPD) |
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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 |
To determine the effect of AER 002 on mucociliary clearance rate of a radiolabeled particle from the lungs of patients with COPD after 5 days of treatment with AER 002 (30 mg bid nebulized) |
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E.2.2 | Secondary objectives of the trial |
To determine the effects of AER 002 on symptoms (cough, breathlessness, sputum production, oxygen use and general feeling), sputum production while in the clinic, spirometry (FEV1, FVC, PEF, small airways resistance as measured by impedance osillometry). |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
(a) Males or females diagnosed with chronic obstructive pulmonary disease; (b) Aged >40 yrs (c) Subjects who have an FEV1 of 75% or less of predicted at time of screening (d) Subjects who, if female, are not currently pregnant or breast feeding and using medically acceptable methods of contraception, or are post-menopausal or surgically sterile. (e) Subjects who have a pre-study medical history, physical examination, 12 Lead ECG acceptable to the Investigator. (f) Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening. (g) Subjects who are negative for drugs of abuse and alcohol tests at screening. (h) Must be willing and able to participate in the whole study and must provide written informed consent;
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E.4 | Principal exclusion criteria |
(a) Subjects who have ever sought advice from a General Practitioner or counselor for abuse or misuse of alcohol, non-medical, medicinal drugs, or other substance abuse e.g. solvents. (b) Positive drugs of abuse test result. (c) Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator. (d) Upper or lower respiratory tract infection (excluding otitis media) within 7 days of the first study day (Day 1 of dosing) (requiring antibiotics for that infection) (e) Subjects who have had a change in their COPD medication in the 4 weeks prior to study entry (f) Any other significant disease or condition which may interfere with the compound or outcome of the study e.g. metabolic conditions, renal, cardiac or hepatic conditions. (g) Participation in a clinical research study in the past 3 months (h) Subjects who use ambulatory oxygen >10 hours per day (i) Subjects who have had past lung surgeries for COPD (excluding routine biopsies) (j) Subjects who are currently taking tiotropium bromide (SPIRIVA®) (k) Subjects who are currently not producing a lot of sputum in the opinion of the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Effects of AER 002 on mucociliary clearance in patients with COPD. |
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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 | Information not present in EudraCT |
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 |
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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 | 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.8.5 | 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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
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 | 5 |