A randomized, double-blind, parallel group, multi-center study to evaluate the long-term safety of salbutamol rescue medication when administered via metered dose inhalers containing the propellant HFA-152a or reference HFA-134a.

Conditions

Asthma

Brief summary

Incidence of AEs throughout the 3 months treatment period

Detailed description

Incidence of SAEs, Minimum serum potassium, Absolute values for serum potassium at each assessed visit, Change from baseline for serum potassium at each assessed visit., Absolute values for clinical laboratory assessments at each assessed visit., Change from baseline for clinical laboratory assessments at each assessed visit, Absolute values for vital signs parameters (systolic blood pressure, diastolic blood pressure, pulse rate) at each assessed visit, Change from baseline for vital signs parameters (systolic blood pressure, diastolic blood pressure, pulse rate) at each assessed visit., Absolute values for 12 Lead ECGs in QTc and heart rate at each assessed visit, Change from baseline for 12 Lead ECGs in QTc and heart rate at each assessed visit., Change from baseline for ACQ-6 score at each assessed visit., Change from baseline for pre-bronchodilator FEV1 at each assessed visit

Related papers

No related papers found yet.

Interventions

DRUGVentolin 100 microgramos/inhalación suspensión para inhalación en envase a presión* (*) sin CFC

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Incidence of AEs throughout the 3 months treatment period	—

Secondary

Measure	Time frame
Incidence of SAEs, Minimum serum potassium, Absolute values for serum potassium at each assessed visit, Change from baseline for serum potassium at each assessed visit., Absolute values for clinical laboratory assessments at each assessed visit., Change from baseline for clinical laboratory assessments at each assessed visit, Absolute values for vital signs parameters (systolic blood pressure, diastolic blood pressure, pulse rate) at each assessed visit, Change from baseline for vital signs parameters (systolic blood pressure, diastolic blood pressure, pulse rate) at each assessed visit., Absolute values for 12 Lead ECGs in QTc and heart rate at each assessed visit, Change from baseline for 12 Lead ECGs in QTc and heart rate at each assessed visit., Change from baseline for ACQ-6 score at each assessed visit., Change from baseline for pre-bronchodilator FEV1 at each assessed visit	—

Measure

Time frame

Incidence of SAEs, Minimum serum potassium, Absolute values for serum potassium at each assessed visit, Change from baseline for serum potassium at each assessed visit., Absolute values for clinical laboratory assessments at each assessed visit., Change from baseline for clinical laboratory assessments at each assessed visit, Absolute values for vital signs parameters (systolic blood pressure, diastolic blood pressure, pulse rate) at each assessed visit, Change from baseline for vital signs parameters (systolic blood pressure, diastolic blood pressure, pulse rate) at each assessed visit., Absolute values for 12 Lead ECGs in QTc and heart rate at each assessed visit, Change from baseline for 12 Lead ECGs in QTc and heart rate at each assessed visit., Change from baseline for ACQ-6 score at each assessed visit., Change from baseline for pre-bronchodilator FEV1 at each assessed visit

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Countries

France, Greece, Italy, Poland, Spain

Outcome results

None listed