E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease |
|
E.1.1.1 | Medical condition in easily understood language |
A long term condition affecting breathing, typically precipitated by smoking, and gradually progressive over time. It can be diagnosed by airflow obstruction on breathing tests |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 |
Our primary question is whether changes in muscle structure including gene expression occur during normal daily life in patients with COPD that can be corrected by giving oxygen. To do this we will compare the appearance of and genes expressed in muscle of patients after they have received oxygen and after they have been given air to use at home for 12 weeks. |
|
E.2.2 | Secondary objectives of the trial |
We are interested in how changes in muscles and other pathology of COPD is affected by oxygen, and how this impacts on patients lives. We will therefore measure inflammation in the circulation, store blood for gene expression analysis (to be used only if muscle analyses fail), measure quality of life (CAT questionnaire), assess mental health (HADS questionnaire), measure circulatory function (arterial stiffness), assess activity level at home (Actigraph monitor) and assess walking distance (6 minute walk test). These factors will be compared between patients when they take oxygen and when they take air at home. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Spirometry: post bronchodilator FEV1/FVC <0.7 2) 6MWT: desaturation to less than 90% on walking 3) Blood gas: does not meet criteria for LTOT i.e. pO2 >7.3KPa or >8KPa if co-existent cor pulmonale |
|
E.4 | Principal exclusion criteria |
1) Immobile due to other medical conditions 2) On LTOT 3) Unable to understand or retain information 4) Uncontrolled anginal symptoms 5) Evidence of potential harm from oxygen supplementation on previous capillary gases or dejours test - specifically a rise in CO2 after being given oxygen that is of a clinically significant magnitude |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in gene expression patterns between baseline and end of oxygen treatment, as compared to change from baseline to end of medical air |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks from start of intervention, which is either active (oxygen) or placebo (air) |
|
E.5.2 | Secondary end point(s) |
Quality of life (CAT score), 6 minute walk test distance, level of depression and/or anxiety (HADS), lung function (spirometry), home activity level (Actigraph), blood markers of oxidative stress and inflammation, arterial stiffness, respiratory sensitivity |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
The flowchart within the protocol demonstrates these: for the most part all secondary outcome data is collected at the same time as muscle biopsy data, with the exception of quality of life and home activity which is also checked at the mid point of each treatment i.e. 6 weeks into either active or placebo treatment |
|
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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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
|
The last visit of the last subject enrolled in the trial |
|
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 | 29 |
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 | 29 |