E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008841 |
E.1.2 | Term | Chronic bronchitis |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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) |
|
E.5 End points |
E.5.1 | 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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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
|
|
E.5.2.1 | 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
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 65 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |