MedDRA version: 19.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Unacid® PD oral
375mg, Filmtabletten
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of admi
Sponsors
Hannover Medical School represented by Hannover Clinical Trial Center GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adults, either sex, older than 40 years of age • For female patients, the following conditions are to be met: - has been postmenopausal for at least 1 year, or - is surgically incapable of bearing children, or - is of childbearing potential, and the following conditions are met: o has a negative pregnancy test (urine- or serum-based) immediately before study entry (i.e., before the start of treatment or any other study procedure that could potentially harm the fetus), and one or more of following criteria o must agree to abstinence or use an accepted method of contraception .The subject must agree to continue with the same method throughout the study. o having only female sexual partners o sexual relationship with sterile male partners only • Patients diagnosed with COPD stages I-IV as defined by the Global initiative for chronic Obstructive Lung disease (GOLD). and • Doctor's diagnosis of acute (onset =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Severe exacerbation: defined by need for ventilatory support (indicated by severe dyspnea with failure to respond to emergency treatment and/or persistent hypoxemia (PaO2 45mmHg)) or mental confusion or circulatory insufficiency (need of vasopressors) • Fever (>38.5°C) (more than 4 days) • Known impaired hepatic or renal function • Active or suspected tuberculosis infection of the respiratory tract • Acute exacerbation of asthma • Suspected or known hypersensitivity to, or suspected serious adverse reaction to Sultamicillin • Immunosuppression or Immunosuppressive therapy (cytostatic chemotherapy within last 28 days or neutropenia (neutrophils 14 days; HIV-infection; immunosuppression after organ- or bone marrow transplant)- Patients with metastatic or hematological malignancy, splenectomized patients or patients with known hyposplenia or asplenia • Oral/parenteral antibiotic use within 30 days prior to randomization (a singular administration of antibiotics prior to randomization is allowed) • In-patient treatment within the last 30 days days (because of actual respiratory infections as primary or secondary diagnosis) • An antibiotic is clearly indicated for treatment of a known infection • Known MRSA colonization or infection • Patients with known bronchiectasis • Patients with known bacterial airway colonization (>3 positive sputum cultures in the previous year) • Progressively fatal disease, or life expectancy =6 months • Mononucleosis • Lymphatic leukemia • Severe gastro-intestinal disorders with vomiting and diarrhea • Women who are breast feeding • Patients who have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow up phase. • Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate in a clinical study that there is no relevant increase in the “failure-rate” for patients with acute moderate exacerbations of COPD (AE-COPD) treated with placebo instead of antibiotic treatment both on top of standard of care. A patient is classified as treatment failure if additional antibiotic therapy is required during treatment period or until the test of cure visit ; Primary end point(s): Assessment of additional antibiotic therapy during treatment period or until the test of cure visit ; Timepoint(s) of evaluation of this end point: 1. treatment period (during 5 days after start of treatment) 2. Test of cure (TOC) visit:4 weeks after start of treatment ; Secondary Objective: •To evaluate long-term consequences of Placebo treatment -Relapse rate at late follow-up 1 -Time to relapse •To assess patient’s clinical improvement relative to treatment -Clinical cure rate at the EOT visit -Clinical cure rate at the TOC visit To assess additional efficacy endpoints and health outcome evaluations following 5 days treatment with either placebo or oral sultamicillin with either treatment used as a supplement to the standard of care for patients with acute exacerbations of COPD: -Changes in CAT -Changes in EXACT PRO -Changes in relevant systemic biomarkers and their association to mortality -Additional antibiotic therapy -Time to next exacerbation -Number of exacerbations during follow up -Per-subject relapse rate at the LFU visits in the subset of subjects in the CE population who were clinically cured at the TOC visit -Changes in length of stay in hospital for hospitalized patients -All cause mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Relapse rate at late follow-up (LFU-2; 1 year) and time to relapse clinical cure rate at the EOT visit and clinical cure rate at the TOC visit (both determined by patient-centered outcomes (diary cards assessed daily for 4 weeks); Timepoint(s) of evaluation of this end point: 1. Relapse rate: 1 year after the start of treatment (late follow up 2 (LFU-2)) 2. time to relapse clincal cure rate: after 6 days (EOT Visit) 3. clinical cure rate: 4 weeks after start of treatment (TOC visit) | — |
Countries
Germany
Contacts
Public ContactClinical trial information
CAPNETZ FOUNDATION/Hannover Medical School
Outcome results
None listed