Chronic obstructive pulmonary disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
Conditions
Sponsors
Inmunotek S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Written informed consent. ? Both gender ? Age between 35 and 85. ? Must be able to follow the treatment regimen ? Diagnosis of moderate COPD according to GOLD criteria: Post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: ? Subject outside of age range ? Subject unable to offer cooperation and / or have severe psychiatric disorders ? Pregnant women, breastfeeding or wishing to become pregnant during the study (including assisted reproductive processes), or to reject the use of contraception during the study (including barrier). Women who become pregnant will have to discontinue their participation in this clinical trial. ? Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion ? Subject diagnosed with asthma according to American Thoracic Society and European Respiratory Society.guidelines ? The presence of another diagnosis other than COPD that makes the subject unstable or has a life expectancy <3 years ? Subject who has had an exacerbation 4 weeks before starting the trial. ? Subject that have needed inhaled corticosteroids in the last 4 weeks before starting the trial ? Subject who has received systemic corticosteroids (vo, im, iv) in the last 4 weeks. ? Subject diagnosed with Primary or Secondary Immunodeficiency (ESID criteria) 12 months prior to inclusion in the trial ? Subjects with chronic lymphoproliferative disease ? Subjects with chronic infectious disease (TB, HCV, HIV, HBV) ? Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators. ? Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa ? Subject with COPD and bronchiectasis diagnosed by CT image before age 40 ? Subject with severe COPD ? ? Subject requiring home O2 or Noninvasive Mechanical Ventilation ? Subject with a history of hypersensitivity to any component of the vaccine ? Subject outside of age range ? Subject unable to offer cooperation and / or have severe psychiatric disorders ? Pregnant women, breastfeeding or wishing to become pregnant during the study (including assisted reproductive processes), or to reject the use of contraception during the study (including barrier). Women who become pregnant will have to discontinue their participation in this clinical trial. ? Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion ? Subject diagnosed with asthma according to American Thoracic Society and European Respiratory Society.guidelines ? The presence of another diagnosis other than COPD that makes the subject unstable or has a life expectancy <3 years ? Subject who has had an exacerbation 4 weeks before starting the trial. ? Subject that have needed inhaled corticosteroids in the last 4 weeks before starting the trial ? Subject who has received systemic corticosteroids (vo, im, iv) in the last 4 weeks. ? Subject diagnosed with Primary or Secondary Immunodeficiency (ESID criteria) 12 months prior to inclusion in the trial ? Subjects with chronic lymphoproliferative disease ? Subjects with chronic infectious disease (TB, HCV, HIV, HBV) ? Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators. ? Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa ? Subject with COPD and bronchiectasis diagnosed by CT image before age 40 ? Subject with severe COPD ? ? Subject requiring home O2 or Noninvasive Mechanical Ventilation ? Subject with a history of hypersensitivity to any component of the vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the eficacy of a bacterial vaccine administered sublingually, compared with placebo in subjects with moderate COPD based on the number of exacerbations of COPD ;Primary end point(s): To evaluate the eficacy of a bacterial vaccine administered sublingually, compared with placebo in subjects with moderate COPD based on the number of exacerbations of COPD ;Timepoint(s) of evaluation of this end point: The baseline and the end of the study;Secondary Objective: - Severity of COPD exacerbations - Time from start of treatment until the first exacerbation of COPD. - Use of drugs (antibiotics, steroids, etc) - Number of doctor visits due to COPD exacerbations - Number of ER Visits: resulting in hospitalization or not resulting in hospitalization - Number of hospitalizations due to COPD exacerbations - Days of hospitalization due to COPD exacerbations - Quality of life related to health, as determined using an adapted version of: Questionnaires on quality of life: COPD Assessment Test (CAT) - Health costs during COPD exacerbations occurring during the trial period. -Changes in the immunological parameters - Safety Variables: adverse events, and evaluation of the local tolerability-reactions at the site of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - Baseline - Visit 1 (first IMP intake) - Visit 2 (3 months after visit 1) - Visit 3 (6 months after visit 1) - Visit 4 (12 months after visit 1) -Visit 5 (18 months after visit 1);Secondary end point(s): - Severity of COPD exacerbations - Time from start of treatment until the first exacerbation of COPD. - Use of drugs (antibiotics, steroids, etc) - Number of doctor visits due to COPD exacerbations - Number of ER Visits: resulting in hospitalization or not resulting in hospitalization - Number of hospitalizations due to COPD exacerbations - Days of hospitalization due to COPD exacerbations - Quality of life related to health, as determined using an adapted version of: Questionnaires on quality of life: COPD Assessment Test (CAT) - Health costs during COPD exacerbations occurring during the trial period. -Changes in the immunological parameters - Safety Variables: adverse events, and evaluation of the local tolerability-reactions at the site of administration | — |
Countries
Spain
Contacts
Public ContactMiguel Casanovas; Medical Director
Inmunotek S.L.
Outcome results
None listed