Anti-inflammatory effects of tiotropium in patients with stable COPD

Anti-inflammatory effects of tiotropium in patients with stable COPD - ANTIOFLAM

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002173-22-NL

Enrollment

Registered

2018-11-01

Start date

2018-12-04

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD)

Interventions

Trade Name: Spiriva respimat 2.5 mcg Product Name: Spiriva respimat Pharmaceutical Form: Inhalation powder Pharmaceutical form of the placebo: Inhalatio

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: •Treatment with long-acting anticholinerigcs 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: 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;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;Timepoint(s) of evaluation of this end point: Baseline and after treatment period of 6 weeks	—

Measure

Time frame

Main Objective: 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;Secondary Objective: 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;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;Timepoint(s) of evaluation of this end point: Baseline and after treatment period of 6 weeks

—

Secondary

Measure	Time frame
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;Timepoint(s) of evaluation of this end point: Baseline and after treatment period of 6 weeks	—

Countries

Netherlands

Contacts

Public ContactBenedikt Ditz

University Medical Center Groningen

l.b.ditz@umcg.nl31625649905

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026