Chronic obstructive pulmonary disease MedDRA version: 14.1 Level: PT Classification code 10064107 Term: Pneumocystis jiroveci infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Wellvone
Product Name: Wellvone
Pharmaceutical Form: Oral solution
INN or Proposed INN: ATOVAQUONE
CAS Number: 95233-18-4
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
FISEVI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients over 39 years old. ? Patients who have not submitted an exacerbation in the last 4 months. ? Possibility of obtaining a sample of sputum or oropharyngeal wash samples ? Informed consetn form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 23 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: ? Confirmed diagnosis or suspicion of cancer ? Presence of autoimmune diseases or asma ? Patients infected with HIV ? Use of immunosuppressive or treatment with inhaled corticosteroids ? Presence of exacerbation and / or pneumonia ? Patients with other significant diseases that non-COPD. ? Patients with anemia, leukopenia or thrombopenia ? Patients with impaired renal function (serum creatinine 1.5 x upper limit of normal) ? Patients with diagnosis of liver cirrhosis or chronic hepatitis ? Pregnant, nursing or childbearing women who are not using contraception method at least in previous three months of the trial during this. ? Participation in another trial with an IMP in 30 days previous or 6 semividas (the larger of both) ? Hipersensibility to atovaquone ? Lost follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of atovaquone on systemic inflammatory activity in patients with chronic obstructive pulmonary disease colonized by P. jirovecii.;Secondary Objective: 1. To assess the effectiveness of atovaquone in the eradication of P. jirovecii in patients with chronic obstructive pulmonary disease . 2. To evaluate the decrease in systemic inflammatory response after a specific treatment against P. jirovecii in patients with chronic obstructive pulmonary disease.;Primary end point(s): - Over 50% reduction of the values of IL-6 in serum in each patient after treatment. - Over 50% reduction of the values of IL-8 in serum in each patient after treatment. - Over 50% reduction of the values of TNF-a in serum in each patient after treatment. - Over 50% reduction of the values of ICAM-1 in serum in each patient after treatment.;Timepoint(s) of evaluation of this end point: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Over 30% reduction of the values of IL-6 in serum in each patient one month after finishing treatment. - Over 30% reduction of the values of IL-8 in serum in each patient one month after finishing treatment. -Over 30% reduction of the values of TNF-a in serum in each patient one month after finishing treatment. -Over 30% reduction of the values of ICAM-1 in serum in each patient one month after finishing treatment.;Timepoint(s) of evaluation of this end point: 1 month | — |
Countries
Spain
Contacts
Public ContactClara M. Rosso Fernández
UCICEC Hospital Virgen del Rocio
Outcome results
None listed