Status:
COMPLETED
Anti-inflammatory Effects of Tiotropium in Patients with Stable COPD
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This study aims to assess the anti-inflammatory effects after 6 weeks treatment with tiotropium compared to placebo in patients with stable COPD
Detailed Description
Rationale: Acetylcholine is the primary parasympathetic neurotransmitter in the airways, and induces bronchoconstriction. Since the cholinergic tone appears to be the major reversible component of obs...
Eligibility Criteria
Inclusion
- • 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
- • 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:
- Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
- Hormonal contraception (implantable, patch, oral, injectable).
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
- Continuous abstinence.
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04061161
Start Date
August 19 2019
End Date
December 31 2023
Last Update
September 25 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center
Groningen, Netherlands, 9713 GZ
2
Medical centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD