Advanced Immunological Approach in COPD Exacerbation

NCT02417649 | Completed Phase 4 DMC

• 1 other identifier: PIRRI/CT/001
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 13

Brief Summary

Chronic obstructive pulmonary disease (COPD) are characterized by frequent relapses, often resulting from common bacterial infections. Enhancing the immune response in these patients may decrease the frequency of these relapses. The use of a mechanic Polyvalent Bacterial Lysate (PMBL, Ismigen, 13 bacterial strains)may enhance the immune response and therefore help significantly to the control of relapse in these patients. In the current study the effect of the administration of the PBML to patients older than 40 years, with moderate, severe or very severe COPD, in good or discrete physical condition on the number of relapses in an observation period of 12 months. In addition, the effect of the PMBL on the duration of the interval between relapses, on relapse symptoms, on the use of other drugs, on the number of days of absence of work, on the number of hospitalizations and duration thereof and on potential toxicity of the treatment.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• To demonstrate the clinical efficacy of Ismigen in patients with moderate, severe and very severe COPD (M/S/VS-COPD) according to GOLD classification, in terms of reduction of the number of exacerbations in a 12 month observation period.

  1 year

Secondary Outcomes (9)

• Effect of Ismigen on the interval between each exacerbation.

  1 year

• Effect of Ismigen on disease symptoms (fever, dyspnoea).

  1 year

• Ability of Ismigen to reduce the use of other drugs (antibiotics, antinflammatory drugs, bronchodilators, mucolytics, etc.) in patients with documented M/S/VS-COPD.

  1 year

• Ability of Ismigen to reduce the number of days of absence from work in patients with documented M/S/VS-COPD.

  1 year

• Number of patients with adverse events as a measure of safety and tolerabiity.

  1 year

Study Arms (2)

Ismigen

EXPERIMENTAL

Treatment over 3 successive months. One sublingual tablet every day on the first ten days of each month, followed by twenty days of rest.

Biological: Ismigen

Placebo

PLACEBO COMPARATOR

Treatment over 3 successive months. One sublingual tablet every day on the first ten days of each month, followed by twenty days of rest.

Biological: Placebo

Interventions

Placebo BIOLOGICAL

1. The placebo will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical. 2. Three months of rest, according to the indications, will be allowed. 3. A second cycle (the same as point 1.) will be performed 4. A second three month rest (according to point 2.) will be provided.

Placebo

Ismigen BIOLOGICAL

1. The tablet will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical. 2. Three months of rest, according to the indications, will be allowed. 3. A second cycle (the same as point 1.) will be performed 4. A second three month rest (according to point 2.) will be provided.

Ismigen

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented moderate, severe and very severe COPD
• Age greater than or equal to 40 years.
• Female patient must be non-lactating and of non-childbearing potential, surgically sterile, or using effective contraception.
• Patients must have WHO performance status of 0, 1 or 2.
• Patients must have adequate hematological, renal and liver function as defined by laboratory values below performed within 14 days, inclusive, prior to study randomization.
• Smokers, ex-smokers can be included but the smoking status is acquired and accurately recorded
• Absolute neutrophil count (ANC) ≥ 2.0 x 109/l.
• Platelet count ≥ 100 x 109/l.
• Hemoglobin ≥ 10 g/dl (\> 6.2 mmol/l).
• Urea and serum creatinine \<1.5 times upper limit of laboratory normal (ULN).
• Total serum bilirubin \<1.5 times ULN.
• ALAT or ASAT \<5 times ULN.
• Alkaline phosphatase \<5 times ULN.
• Gammaglutamyltransferase (GGT) \<5 times ULN.
• LDH \<5 times ULN.

You may not qualify if:

• Patients who had received any prior antineoplastic drug therapy or immunosuppressive drugs.
• Patients under continuous treatment with systemic steroids.
• Presence of severe cardiac disease including uncontrolled angina pectoris and myocardial infarction within 6 months, uncontrolled high blood pressure.
• Presence of severe respiratory disease as identified from spirometry and/or chest X ray.
• Presence of any other uncontrolled severe medical condition including active gastroduodenal ulcer, alcohol disorders ( hepatitis, Korsakoff syndrome..), diabetes, active or uncontrolled infection, evolutive intracranial hypertension"
• Patients pregnant or nursing at the beginning of the study.
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Sponsors & Collaborators

• Lallemand Pharma AG: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (13)

Pneumology Department - San Paolo Hospital

Milan, Milan, 20142, Italy

Location

Respiratory Physiopatology and Pneumology Unit, Di Circolo Predabissi-Melegnano hospital

Vizzolo Predabissi, MI, Italy

Location

Respiratory and Pulmonary desease Unit - IRCCS San Matteo

Pavia, Pavia, 27100, Italy

Location

Specialistic Rehabilitation (Pneumolgi Unit),"Carlo Mira" hospital

Casorate Primo, PV, Italy

Location

Rehabilitation Pneumology Unit, IRCCS San Raffaele Pisana

Rome, RM, Italy

Location

Respiratory Clinical Pharmacology, Department of Internal Medicine, Tor Vergata Hospital

Rome, RM, Italy

Location

Broncopneumology and Allergology Unit, Abbiategrasso hospital

Abbiategrasso, Italy

Location

Respiratory Physiopatology Unit, Mellino Mellini hospital

Chiari, Italy

Location

Pneumology Unit, Cremona hospital

Cremona, Italy

Location

Allergy and Respiratory Diseases Clinic, San Martino hospital

Genova, Italy

Location

Pneumology Unit, San Gerardo hospital

Monza, Italy

Location

Complex structure of Pulmonary Allergy, Cardarelli hospital

Naples, Italy

Location

Complex structure of Pulmonary Rehabilitation, Cardarelli hospital

Naples, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giorgio Walter Canonica, Prof. MD

  University of Genova, Genova, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: April 15, 2015
• Study Start: September 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

IT (13)