E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease (COPD) |
Chronisch obsructieve longziekte (COPD) |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic obstructive pulmonary disease (COPD)
Pulmonary emphysema |
Chronisch obsructieve longziekte (COPD
Longemfyseem
"rek uit de longen" |
|
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 |
A decrease of leukotriene B4 in induced sputum will be the main parameter for assessing the anti-inflammatory effects of 6 week treatment with tiotropium in patients with stable COPD |
De primaire uitkomstmaat is de afname van leukotriene B4 in geinduceerd sputum i.v.m. het bepalen van anti-inflammatoire effecten na 6 weken behandeling met tiotropium. |
|
E.2.2 | Secondary objectives of the trial |
Additionally, changes in sputum cell differentials and other cytokine parameters (protein, mRNA), blood cell differentials, CRP, and cytokine parameters, health related quality of life (CCQ, CAT) will be assessed as well as changes in post-bronchdilator FEV1 |
Verder, worden verandering in sputum cell differentials en cytokine (eiwitten, mRNA), bloed cell differentials, CRP en bloed cytokine parameters, kwaliteit van leven (CCQ, CAT vragenlijsten) en verandering in post-bronchodilator FEV1. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Men or women, age >= 40 years
•post-bronchodilator FEV1 >= 1.5 Litres
•smoking history of > 10 pack years.
•Being in a stable phase of COPD, as judged by the investigator. No courses of systemic steroids last 4 weeks
•Post-bronchodilator FEV1 / FVC ratio < 70% and post-bronchodilator FEV1 < 80%pred |
-leeftijd >= 40 jaar
-post-bronchodilatore FEV1 >= 1.5 Litres
-Rookhistorie van > 10 pack years.
-stabiele COPD. Geen systemische steroide gedurende 4 weken
-post-bronchodilatore FEV1 / FVC ratio < 70% en post-bronchodilatore FEV1 < 80%pred. |
|
E.4 | Principal exclusion criteria |
•Treatment with long-acting anticholinerigcs <4 weeks before the start of the study.
•Treatment with corticosteroids <4 weeks before the start of the study.
•Concomitant diagnosis of asthma.
•Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
a) Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
b) Hormonal contraception (implantable, patch, oral, injectable).
c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
d) Continuous abstinence. |
-behandeling met langwerkend anicholinergicum <4 weken voor studie begin
-behandeling met corticosteroïden < 4 weken voor studie begin
-asthma diagnose
-vruchtbare vrouwen zonder effectieve anticoncenptie tenzij ze post-menopauzaal zijn: 12 maanden natuurlijke/spontane amenorrhoe van 6 manden of 6 maanden spontane amenorrhoe met serum FSH >40 mIU/mL of het gebruik van 1 of meerdere van de volgende middelen van anticonceptie:
a) chirurgische sterilizatie (bilaterale tubulaire ligatie, hysterectomie)
b) hormonale anticonceptie (implanteerbaar, oraal, injecteerbaar).
c) Barriere methode van anticonceptie (condoom of afsluitende kap) met spermicide foam/gel/zetpil.
d)continue abstinentie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is leukotriene B4 decrease in induced sputum for assessing the anti-inflammatory effects of 6 week treatment with tiotropium in patients with stable COPD |
De primaire uitkomstmaat is de afname van leukotriene B4 in geinduceerd sputum i.v.m. het bepalen van anti-inflammatoire effecten na 6 weken behandeling met tiotropium. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and after treatment period of 6 weeks |
Baseline en na 6 weken behandeling |
|
E.5.2 | Secondary end point(s) |
Changes in sputum cell differentials and other cytokine parameters (protein, mRNA), blood cell differentials, CRP, and cytokine parameters, health related quality of life (CCQ, CAT) will be assessed as well as changes in post-bronchdilator FEV1 |
Verandering in sputum cell differentials en cytokine (eiwitten, mRNA), bloed cell differentials, CRP en bloed cytokine parameters, kwaliteit van leven (CCQ, CAT vragenlijsten) en verandering in post-bronchodilator FEV1. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and after treatment period of 6 weeks |
Baseline en na 6 weken behandeling |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | 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) | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | 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
|
Last visit of the last subject |
Laatste bezoek van de laatste persoon in de studie |
|
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 |