Double treatment with Glycopyrronium and Indacaterol versus single treatment with Glycopyrronium in treatment of lung disease

Dual therapy with Glycopyrronium and Indacaterol versus monotherapy with Glycopyrronium in treatment of Copd patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-7k576j

Enrollment

Unknown

Registered

2018-10-04

Start date

2018-10-12

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary emphysema

Interventions

This study is a cross-over clinical trial. The study is primary, analytical, longitudinal (with follow-up of approximately 3 months) and prospective, randomized, double-blind and interventional. That

Drug

D27.505.696.663.050.110

D27.505.519.625.050.100.200.200

D12.776.543.750.695.475.100

D12.776.543.750.695.475.200

D12.776.543.750.695.475.300

Eligibility

Age

18 Years to 90 Years

Inclusion criteria

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

Exclusion criteria: Patients with respiratory tract infection or who have been hospitalized for an exacerbation in the last month.

Design outcomes

Primary

Measure	Time frame
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. 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. 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.	—

Measure

Time frame

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. 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. 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

Measure	Time frame
Secondary outcomes are not expected	—

Countries

Brazil

Contacts

Public ContactEmanuelle Ferreira

Hospital de Clínicas da Universidade Federal do Paraná

emanuelleleonelelf@gmail.com+55-41-998130445

Outcome results

None listed

Source: REBEC (via WHO ICTRP)