Overview

Anti-inflammatory Effects of Tiotropium in Patients With Stable COPD

Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
Summary
This study aims to assess the anti-inflammatory effects after 6 weeks treatment with tiotropium compared to placebo in patients with stable COPD
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Medical Center Groningen
Collaborator:
Boehringer Ingelheim
Treatments:
Anti-Inflammatory Agents
Bromides
Tiotropium Bromide
Criteria
Inclusion Criteria:

- • Men or women, age >= 40 years.

- A diagnosis of COPD according to the criteria of the GOLD organization

- Post-bronchodilator FEV1 / FVC ratio < 70% (ERS equations) and
post-bronchodilator FEV1 < 80%pred.

- A smoking history of > 10 pack years.

- post-bronchodilator FEV1 > 1.5 Litres and ability to produce sputum after
hypertonic saline induction.

- No upper or lower respiratory tract infection in the last 4 weeks necessitating
antibiotic treatment or consisting of quite probable viral etiology.

- Being in a stable phase of COPD, as judged by the investigator. No courses of
systemic steroids or antibiotics for respiratory problems last 4 weeks

- The participant needs to be able to understand the Dutch language

- Signed and dated informed consent obtained before any study related procedures
(including withdrawal of concomitant medication) are conducted.

Exclusion Criteria:

- • Treatment with immune-modulating agents for any disease, including leuktriene
receptor antagonists,

- Treatment with long-acting anticholinergics <4 weeks before the start of the
study.

- Treatment with corticosteroids <4 weeks before the start of the study.

- Targeted lung denervation therapy in the past.

- Concomitant diagnosis of asthma.

- Any significant other pulmonary disease or disorder (e.g. known
alpha1-antitrypsine deficiency, significant bronchiectasis), as judged by the
investigator.

- Narrow angle glaucoma.

- Azithromycine maintenance treatment.

- Active malignant disease (at least 5 years malignant disease-free)

- Other significant disease or disorder (like cardiovascular, gastrointestinal,
liver, renal, neurological, musculoskeletal, endocrine, metabolic (including
diagnosed diabetes), malignant, psychiatric, major physical impairment), which,
in the opinion of the investigators may either put the patient at risk because of
participation in the study, or may influence the results of the study, or the
patient's ability to participate in the study.

- 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:

1. Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).

2. Hormonal contraception (implantable, patch, oral, injectable).

3. Barrier methods of contraception: condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/cream/suppository.

4. Continuous abstinence.