Double treatment with Glycopyrronium and Indacaterol versus single treatment with Glycopyrronium in treatment of lung disease
Phase 4
- Conditions
- pulmonary emphysemapulmonary diseasechronic obstructiveC08.381.495.389.750C08.381.495.389
- Registration Number
- RBR-7k576j
- Lead Sponsor
- Hospital de Clínicas da Universidade Federal do Paraná
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Patients (men and women) with COPD confirmed by spirometry. The diagnosis of the disease will be made by performing spirometry that will confirm the obstruction to the airflow through the result of the relation between forced expiratory volume in the first second (FEV1) and forced vital capacity of less than seventy per cent after use of inhaled bronchodilator. The patient must have stable disease. No need for hospitalization in the thirty days prior to the evaluation. Preserved neurocognitive functions. Be an adult and agree to participate in the study.
Exclusion Criteria
Patients with respiratory tract infection or who have been hospitalized for an exacerbation in the last month.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>The primary endpoint is a greater benefit and therapeutic efficacy when adding a second bronchodilator in the treatment of chronic obstructive pulmonary disease (COPD) in patients with moderate COPD.<br>For this the main outcome will be analyzed through spirometry. The variable analyzed for this is the forced expiratory volume in the first minute (FEV1) pre-bronchodilatation, as seen by the spirometry examination. It is a variable of drug effectiveness.<br>In summary: pre-bronchodilation FEV1 is expected to increase after treatment with double therapy when compared to treatment with monotherapy. This increase should be statistically significant.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are not expected