E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease COPD |
chronische obstructieve longaandoening COPD |
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E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
E.1.2 | System Organ Class | 100000004855 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010953 |
E.1.2 | Term | COPD exacerbation |
E.1.2 | System Organ Class | 100000004855 |
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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 |
To assess the time to first exacerbation of COPD, measured from the time of randomization |
Het bepalen van de tijd tot eerste exacerbatie, gemeten vanaf moment van randomisatie |
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E.2.2 | Secondary objectives of the trial |
To evaluate the improvement of quality of life by Saint George’s Respiratory Questionnaire; · To evaluate pulmonary function (FEV1) · To evaluate the frequency of exacerbation requiring an intervention with systemic corticosteroids and antibiotics (oral/intravenous [i.v.]) in subjects with COPD. · To assess the microbiology of sputum production · To assess the safety and tolerability of long term azithromycin · To assess the inflammatory response measured by the following inflammatory markers: high-sensitivity C-reactive protein, the erythrocyte sedimentation rate, polymorphonuclear leukocytes, neutrophils; eosinophils; interleukin-6, interleukin-8, and myeloperoxidase;
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Om de verbetering van de kwaliteit van leven te evalueren met behulp van de SGRQ vragenlijst · De longfunctie evalueren (FEV1) · Om de frequentie van exacerbatie te evalueren die een interventie met systemische corticosteroïden en antibiotica (oraal / intraveneus [i.v.]) vereist bij personen met COPD. · Om de microbiologie van sputumproductie te beoordelen · Om de veiligheid en verdraagbaarheid van azithromycine op lange termijn te beoordelen · Om de ontstekingsreactie te meten gemeten met de volgende ontstekingsmarkers: C-reactief eiwit met hoge gevoeligheid, de bezinkingssnelheid van erytrocyten, polymorfonucleaire leukocyten, neutrofielen; eosinofielen; interleukine-6, interleukine-8 en myeloperoxidase; |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
COPP patients with azithromycin maintenance therapy for at least 12 montsh and who have a stable exacerbation rate (2 or less exacerbations a year). The initial indication for azithromycin maintenance therapy should be frequent exacerbations (>3 exacerbations a year) |
COPD patienten met azitromycine onderhoudsantibiotica voor reeds minimaal 12 maanden gebruikt en die een lage exacerbatiefrequentie hebben (2 of minder exacerbaties per jaar). De indicatie voor het starten van de azitromycine onderhoudsbehandeling moet een hoog aantal exacerbaties zijn. |
|
E.4 | Principal exclusion criteria |
Bronchiectasis Asthma Antibiotics and prednisolon treatment because of an exacerbation in the last month prednisolone maintenance more than 5mg a day |
bronchiëctasieën astma antibiotica of prednisonkuur voor een exacerbatie in de afgelopen maand vooraf aan inclusie prednison onderhoud meer dan 5mg per dag |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to first exacerbation |
Tijd tot eerste exacerbatie |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
end of the study |
eind van de studie |
|
E.5.2 | Secondary end point(s) |
Quality of life Lungfunction parameters Exacerbation frequency Sputum microbiology Systemic inflammation Safety of prolonged azithromycin usage |
Kwaliteit van leven Longfunctie parameters Exacerbatiefrequentie Sputum microbiologie Systemische Ontstekingsreactie Veiligheid langdurig azitromycine gebruik |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
end of study |
eind van de studie |
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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 | 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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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
|
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |