COPD- Chronic Obstructive Pulmonary Disease MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Avelox
Product Name: Avelox (Moxifloxacin)
Product Code: N/A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: moxifloxacin
CAS Number: 354812-41-2
Current Sponsor code: N/A
Oth
Sponsors
University College London (UCL)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Confirmed COPD diagnosis * Informed Consent: Patients must give their signed and dated written informed consent to participate * Gender: Male or female patients * Age: = 45 years of age at screening * Produce sputum regularly (produce sputum in at least 3 months of a year) * Able to complete questionnaires for health status and symptoms and considered able to comply with the dosing regimen. * Severity of disease: Patients with a measured FEV1=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: •Patients with Tuberculosis, other chronic respiratory disease (e.g. chronic asthma, bronchiectasis, pulmonary fibrosis), patients with hepatic or renal impairment and patients with prolonged QT interval and other cardiac abnormalities. •Patients with known hypersensitivity to the antibiotics under evaluation. •Patients on long term antibiotics for other conditions. •Patients with uncontrolled hypertension. •Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding. •Patients with a history of long QT syndrome or whose QTc measured at Visit 1 is prolonged (>450 msec for males and females) as confirmed by the ECG assessor. •Clinically relevant abnormal laboratory values at the screening assessment that could interfere with the objectives of the trial or safety of the volunteer. •Patient taking clinically significant contraindicated medication, as per the SmPCs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research question/objective is to identify the most effective antibiotic regime at reducing airway bacterial numbers in stable COPD patients in a developmental 13 week study, using three different antibiotic regimes together with a placebo. Safety outcomes will include bacterial resistance patterns, adverse events and tolerability of the regimes.;Secondary Objective: The secondary research questions/objectives of this study are to understand the following: To measure changes in spirometry (lung function measure), health status (by St. Georges Respiratory Questionnaire (SGRQ) and daily diary cards, and exacerbations (using daily diary cards). To assess patient adherence to 13 weeks antibiotic/placebo treatment.;Primary end point(s): The primary outcome for this study is the 3 month fall in sputum bacterial load in patients with stable COPD. Sputum will be analysed for bacterial numbers by routine culture methods, and quantitative bacterial detection will be performed using PCR which provides a more accurate estimate of bacterial numbers. Safety outcomes will include bacterial resistance patterns, adverse events and tolerability of the regimes.;Timepoint(s) of evaluation of this end point: Analysis of bacterial numbers will be evaluated at week 14 (i.e. at the end of the trial) and compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end point include: •The number of exacerbations recorded from date of drug issue until date of end of treatment visit (week 14) (measured from daily diary cards/ recorded on CRFs) •Total and individual components separately (Symptoms, activity, impact) of St George’s Respiratory Questionnaire (SGRQ) score to measure health status, ranging from zero (no impairment) to 100 (maximum impairment). • EQ5D (A standardised instrument for use as a measure of health outcome in Work Package 5 (a future work package (study) investigating the cost-effectiveness of antibiotics in COPD patients) •Lung function (spirometry). • Antibiotic resistance measured from sputum based on standard NHS procedures (severe, intermediate, resistant) • Adherence (pill counts) Spirometry, resistance, SGRQ and EQ5D* will be measured and assessed at the end of the trial and compared to baselines taken prior to treatment. Adherence, including MAQ4 and MAQ8, will be measured and will form part of two inter-related studies in the future (WP5 and WP6).;Timepoint(s) of evaluation of this end point: Secondary end points will be evaluated at week 14 (i.e. at the end of the trial) and compared to baseline. | — |
Countries
United Kingdom
Contacts
Public ContactAlison Evans
University College London (UCL)
Outcome results
None listed