E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We propose a study to examine whether adjuvant magnesium therapy administered via nebuliser is effective in the management of patients with acute exacerbations of COPD. The findings should help to provide the basis for determining the use of magnesium in the management of patients presenting to the Emergency Department with Chronic Obstructive Pulmonary Disease). |
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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 examine whether adjuvant magnesium therapy administered via nebuliser is effective in the management of patients with acute exacerbations of COPD. The primary outcome measure of the trial is FEV1 (spirometry) (Forced Expiratory Volume in 1 second). |
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E.2.2 | Secondary objectives of the trial |
The secondary outcome measures of the trial are: FVC (Forced Vital Capacity) Discharge within 48 hrs Risk of requiring NIV or intubation or escalation of treatment Length of hospital stay Arterial blood gas tensions Modified BORG score
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· 35 to 80 years old · Diagnosis of COPD as defined by the American Thoracic Society · Presentation to the ED with an acute exacerbation of COPD · FEV1 ≤ 70 % · FEV1 / FVC ratio < 70 % · ³ 20 pack year smoking history
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E.4 | Principal exclusion criteria |
· Patients requiring intubation, NIV or too severe to perform spirometry · Arterial pH <7.32 · Clinical history of asthma · Known cardiac disease, chronic renal insufficiency or other serious medical condition · Pregnant women · Clinical or radiographic evidence of pneumonia · Hypotension (systolic blood pressure < 100 mmHg)
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E.5 End points |
E.5.1 | Primary end point(s) |
FEV1 (Forced expiratory volume in one second) |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
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 | Yes |
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) | Information not present in EudraCT |
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.8.5 | 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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The end of the trail is defined as one month after the date of the last treatment visit for the last patient undergoing protocol treatment. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |