Efficacy and safety study of Fluticasone Furoate/Vilanterol on the dose of 100/25 microgram (mcg) inhalation powder, Fluticasone Propionate/Salmeterol on the dose of 250/50 mcg inhalation powder and Fluticasone Propionate on the dose of 250 mcg inhalation powder in adults and adolescents with persistent asthma
- Conditions
- Persistent asthma
- Registration Number
- RBR-4f9tcc
- Lead Sponsor
- GlaxoSmithKline Brasil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method