Chronic bronchitis MedDRA version: 14.1 Level: LLT Classification code 10008841 Term: Chronic bronchitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
OM Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patients of either sex aged = 65 years - chronic bronchitis with at least 3 documented acute infections of the lower respiratory tract in the previous year having a change in regular medication - conscious and not bedridden invalid - able to understand the study purpose - patients having given their written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: - allergic asthma or primary emphysema (Alpha-1 antitrypsin deficiency) - FEV1 2 times upper limit of normal range of serum creatinine - hepatic insufficiency: >2 times upper limit of normal range of SGOT (ASAT) or SGPT (ALAT) - patient treated with the following medications: oral vaccination with live vaccine within 4 weeks before study start, previous and/or concomitant immunosuppressive or immunostimulating therapy (including chemotherapy, radiotherapy) within 6 months before study start, regular oral corticosteroids > 20 mg of prednisolone per day more than 2 weeks - known allergy to bacterial agents - unable to follow instructions, and unreliable patients including non-compliant patients, patients with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol, i.e. unable to complete a patient diary - participation in another clinical trial within the past 4 weeks prior to this trial -patients who do not accept intermediary phone calls (IPCs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess new data about the preventive efficacy of Broncho-Vaxom compared to placebo against acute lower respiratory tract infections in elderly patients with chronic bronchitis.;Secondary Objective: The secondary Efficacy variables are: - Type, severity and duration of the lower respiratory tract infections - Type and duration of prescibed concomitant treatment(s) - Number and duration of hospitalizations and deaths related to respiratory disease - Spirometry with FEV1 and FVC - Global assessment of efficacy;Primary end point(s): Mean rate of acute lower respiratory tract infections up to the end of the treatment period, i. e. mean of the total number of respiratory tract infections per patient.;Timepoint(s) of evaluation of this end point: Visit 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Type, severity and duration of the lower respiratory tract infections • Type and duration of prescribed concomitant treatment(s) • Number and duration of hospitalizations and deaths related to respiratory disease • Spirometry (FEV1 and FVC) at V2 or V3, V4-V8 • Global assessment of efficacy by patient and investigator at V10 ;Timepoint(s) of evaluation of this end point: All along the study for: • Type, severity and duration of the lower respiratory tract infections • Type and duration of prescribed concomitant treatment(s) • Number and duration of hospitalizations and deaths related to respiratory disease • Spirometry (FEV1 and FVC) at V2 or V3, V4-V8 • Global assessment of efficacy by patient and investigator at V10 | — |
Countries
Germany
Contacts
Public ContactAude Chevalier
OM Pharma SA
Outcome results
None listed