Persistent asthma
Conditions
Interventions
E05.318.780.300
The study will randomize 1461 subjects with asthma aged with 12 or more than 12 years in three treatment arms. In Brazil about 80 patients will be included in the study.
Arm 1 drug: Subjects will rece
Arm 2 drug: Subjects will receive 250/50 micrograms (mcg) Fluticasone Propionate/Salmeterol twice a day plus placebo by inhalation once daily by inhalation
Arm 3 drug: Subjects will receive 250 micrograms(mcg) of Fluticasone Propionate twice a day plus placebo by inhalation once a day by inhalation
Drug
V03.200.300
Sponsors
GlaxoSmithKline Brasil
GlaxoSmithKline Brasil
Eligibility
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must give their signed and dated written informed consent to participate prior to start any study activities; Subjects must be outpatients equal or more than 12 years of age at visit 1 and diagnosed with asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to visit 1; Male and female (if eligible). An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at screening and agrees to use an acceptable method of birth control consistently and correctly; Subjects must have a FEV of equal or more than 80% of the predicted normal value; If they have received mid dose of inhaled corticosteroids(ICS) plus Beta-2 agonist prolonged action (LABA), equivalent to Fluticasone Propionate/Salmeterol 250/50 micrograms(mcg) twice daily or an equivalent combination via separate inhalers for at least the 12 weeks immediately preceding visit 1; Subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at visit 1 for use, as needed, for the duration of the study. Subjects must be able to with hold albuterol/salbutamol for at least 6 hours prior to study visits; If in the opinion of the investigator the subject's asthma is well controlled
Exclusion criteria
Exclusion criteria: History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years; Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of visit 1 and led to a change in asthma management or in the opinion of the investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study; Any asthma exacerbation requiring oral corticosteroids within 12 weeks of visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to visit 1; A subject must not have current evidence of atlectasis, bronchopulmonary dysplasia, chronic bronchitis, chronic obstructive pulmonary disease, pneumonia, pneumothorax, interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma; A subject must not have any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study; A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study, whichever is longer of the two; Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the study molecules; History of severe milk protein allergy; Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug; A subject must not be using or require the use of immunosuppressive medications during the study; A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries; Current tobacco smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products or inhaled marijuana within the past 3 months (e.g., cigarettes, cigars, electronic cigarettes, or pipe tobacco); A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in clinic visit evening (PM) forced expiratory volume in one second (FEV) (pre-bronchodilator and predose) at the end of the 24-week treatment period, Time Frame: Baseline and Week 24, Designated as safety issue: No. FEV is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline will be the pre-dose value obtained at the visit 3 clinic visit. Change from baseline will be calculated as the week 24 value minus the baseline value | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the percentage of rescue-free 24-hour periods during the 24-week treatment period Change from baseline in the percentage of symptom-free 24-hour periods during the 24-week treatment period Change from baseline in morning (AM) Peak Expiratory Flow (PEF) averaged over the 24-week treatment period. PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated Percentage of subjects controlled, defined using an Asthma Control Test (ACT) score equal or more than 20 at the end of the 24-week treatment period Change from baseline in PEF (PM) averaged over the 24-week treatment period | — |
Countries
Argentina, Brazil, Chile, Czech Republic, Germany, Italy, Mexico, Netherlands, Republic of Korea, Romania, Russian Federation, Spain, United States
Contacts
Public ContactServiço de Atendimento ao Cliente SAC
GlaxoSmithKline Brasil
Outcome results
None listed