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.