Broncho-Vaxom in Elderly Patients with Chronic Bronchitis

Conditions: Chronic bronchitis
MedDRA version: 14.1Level: LLTClassification code 10008841Term: Chronic bronchitisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2007-005637-11-DE

Lead Sponsor: OM Pharma SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

- allergic asthma or primary emphysema (Alpha-1 antitrypsin deficiency)
- FEV1 < 50% predicted
- history of cancer in the last year
- cardiovascular heart failure with NYHA stage III or IV
- renal insufficiency: >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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- Type, severity and duration of the lower respiratory tract infections<br>- Type and duration of prescibed concomitant treatment(s)<br>- Number and duration of hospitalizations and deaths related to respiratory disease<br>- Spirometry with FEV1 and FVC <br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): •Type, severity and duration of the lower respiratory tract infections<br>•Type and duration of prescribed concomitant treatment(s)<br>•Number and duration of hospitalizations and deaths related to respiratory disease<br>•Spirometry (FEV1 and FVC) at V2 or V3, V4-V8<br>•Global assessment of efficacy by patient and investigator at V10<br>;Timepoint(s) of evaluation of this end point: All along the study for: <br>•Type, severity and duration of the lower respiratory tract infections<br>•Type and duration of prescribed concomitant treatment(s)<br>•Number and duration of hospitalizations and deaths related to respiratory disease<br><br>•Spirometry (FEV1 and FVC) at V2 or V3, V4-V8<br>•Global assessment of efficacy by patient and investigator at V10<br>