Bronchial Asthma
Conditions
Interventions
Will be designed two treatment groups. Group I: The patients will receive treatment with Vimang®, pills of 600mg, oral way, two pills every 12 hours, plus the specific therapy. Group II: The patients
Sponsors
Center of Pharmaceutical Chemistry
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: -Patients of both sexes, between 20 and 45 years of age, non smokers, who are attended in ambulatory clinics, with diagnosis of persistent moderate asthma that they will be classified by the obstruction degree by spirometry according to Gina 2006. -Patient that are of agreement with participating in the clinical trial -Patients have carried out a Respiratory Functional Test (RFT) with test pre and post bronchial dilator before beginning to take the Vimang® and that it expresses a limitation to the air, reversible or partially reversible flow with bronchial dilator(inhaled Salbutamol).
Exclusion criteria
Exclusion criteria: - Smoking Patients. - Pregnancy or nursing. - Patients that have normal RFT. - Patient without antecedents of bronchial asthma. - The patient's negative to fulfill the established dose of the Vimang®. - The patient's negative to carry out the protocolized investigations. - Patient that not fulfill with the measures of systematic control: weekly phone calls that include the control of the asthma, besides the biweekly consultation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main variable of answer is the degree of bronchial obstruction according to the FEV1. It will consider positive answer when the predictive % of FEV1, with regard to the value initial pre or post bronchial dilator, improves even when the relationship FEV1/FVC (FEV1%) doesn't improve. This variable will be measured to the beginning, month and half and three months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clinical improvement 1. The spacing of the day symptoms, dyspnea, thoracic oppression, sibilance. 2. The spacing of the night symptoms (cough, sibilance). - Improvement of anyone of the spirometrics variables: 1) Forced Vital Capacity (FVC) 2) Flow Forced Expriring Flow (FEF) among the 25 to 75% of FVC(FEF25-75) 3) Instantaneous Forced Expiring Flow in 50% of the FVC (FEF50) 4) Maximun Expiring Flow Pick FEFmax (PEF) 5) FEV1/FVC (FEV1%) IgE serum concentrations and the levels of cationic protein of the eosinophile cell, as biological marker of inflammation, decrease. These variables will be measured to the beginning, month and half and three months of treatment. | — |
Countries
Cuba
Contacts
Public ContactDr. Alina Alvarez-Leon
Center of Pharmaceutical Chemistry
Outcome results
None listed