E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients enrolled will have a diagnosis of restrictive lung disease diagnosed by a High Resolution CT scan, reduced gas transfer result (obtained from pulmonary function tests) and low lung volumes (obtained from pulmonary function tests). |
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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 | 10033318 |
E.1.2 | Term | Oxygen saturation decreased |
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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 | 10050322 |
E.1.2 | Term | Oxygen supplementation |
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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 aim is to examine if patients walking distance change, measured by a 6 minute walk test, and/or perceive their symptoms to change, measured using a quality of life questionnaire after an 8 week course of ambulatory oxygen compared to a group of patients with the same disease that don't receive oxygen. |
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E.2.2 | Secondary objectives of the trial |
Quality of life measurements associated with this treatment measured using the validated SF-36 quality of life questionnaire. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
− Patients must have a CT confirmed diagnosis of restrictive lung disease as this is the current standard for diagnosing these disorders. − Patients must have an abnormal gas transfer PFT as this is confirmation of the extent of damage to the patients lungs. − Patients must be mobile as this is neccessary to complete a 6 minute walk test. |
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E.4 | Principal exclusion criteria |
− Patients who are not mobile, as they need to complete a six minute walk test. − Patients with poor comprehension, as they will not understand the instructions. − Patients who would be unable to carry or push around an oxygen cylinder. - Patients who are already prescribed long term oxygen therapy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The aim of this study is to investigate the benefit of an 8 week course of ambulatory oxygen on patients with DPLD, both physiologically, measured using a 6 minute walk test, and psychologically, using a quality of life score. Any change in the distance walked during the 6 minute walk test both pre and post oxygen trial, and any change in teh quality of life score will be examined. |
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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 | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The comparator is no oxygen treatment |
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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 | Information not present in EudraCT |
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
|
it is 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 | 2 |
E.8.9.1 | In the Member State concerned days | 14 |