Asthma
Conditions
Interventions
Trade Name: FSC (fluticasone propionate and salmeterol
xinafoate) ROTACAP
Product Name: fluticasone propionate/salmeterol
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: FLUTICASONE PROPIO
Sponsors
GlaxoSmithKline Research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female >=12 and =40% to =12% and >=200 mL reversibility of FEV1 within 10 to 40 minutes after 2 to 4 inhalations of salbutamol inhalation aerosol (or equivalent nebulised treatment with salbutamol solution) at Visit 1 (Screening and Run-in Visit). - Current anti-asthma therapy: All subjects must be using an Inhaled Corticosteroid (ICS) with or without long-acting beta-adrenergic agonist (LABA) for at least 8 weeks and a stable dose for at least 4 weeks before Visit 1 (Screening and Run-in Visit). - Ability to withhold LABA therapy: Other than what is provided during the study, LABA therapy is not permitted on the day of Visit 1 SABA: All subjects must be able to replace their current SABA treatment with rescue salbutamol/albuterol at Visit 1 (Screening and Run-in Visit) for use as needed for the duration of the study. Subjects must be able to withhold salbutamol/albuterol for at least 6 hours before each study visit. - Liver safety criteria: Alanine aminotransferase (ALT) 1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin is =65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: History of life-threatening asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 10 years - Respiratory infection: 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 - Asthma exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 (Screening and Run-in Visit) or that resulted in overnight hospitalisation requiring additional treatment for asthma within 6 months before Visit 1 (Screening and Run-in Visit) - Concurrent respiratory disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma - Other concurrent diseases/abnormalities: A subject must not have any clinically significant, uncontrolled condition or disease state - Evidence of a severe exacerbation, defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalisation or emergency department - Oropharyngeal examination: A subject will not be eligible for the Run-in if he/she has clinical visual evidence of candidiasis at Visit 1 (Screening and Run-in Visit) - Investigational medications: A subject must not have administered any investigational drug within 30 days before Visit - Allergies: Drug allergy; 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 FSC multi-dose inhaler and capsule-based inhaler (i.e., lactose), Milk protein allergy; History of severe milk protein allergy - Concomitant medications: Administration of prescription or over the counter medication that would significantly affect the course of asthma, or interact with study treatment, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants; beta-adrenergic blocking agents; phenothiazines; and monoamine oxidase (MAO) inhibitors - Immunosuppressive medications: A subject must not be using or require use of immunosuppressive medications during the study - Cytochrome P450 3A4 (CYP3A4) inhibitors: Subjects who have received a potent CYP3A4 inhibitor within 4 weeks of Visit 1(Screening and Run-in Visit) (e.g., ritonavir, ketoconazole, itraconazole) - Subject is unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or five half-lives (whichever is longer) before the first dose of study treatment, - Any subjects that have previously received or are currently receiving omalizumab - Use of the excluded medications are included in the study protocol - Compliance: A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location that seems likely (in the opinion of the investigator) to impair compliance with any aspect of this study protocol, including visit schedule and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was to establish the noninferiority of the efficacy of FSC 250/50mcg ROTAHALER compared with FSC 250/50 mcg DISKUS BID in adults and adolescents with asthma.;Secondary Objective: The secondary objectives were the evaluation of the safety, tolerability, and pharmacodynamics of the two inhalers and their effect on the asthma control of these subjects. ;Primary end point(s): Change from Baseline in trough morning Forced expiratory volume in 1 second (FEV1);Timepoint(s) of evaluation of this end point: Up to Day 85 of each Treatment Period | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Timepoints detailed alongside each secondary end point. ;Secondary end point(s): •Change from Baseline in Asthma Control Test (ACT) Time Frame: Baseline and upto Day 85 of each Treatment Period •Estimation of FEV1 area under the curve from 0 to 12 hours (AUC [0-12]) at Day 85 Time Frame: Predose, 15 minutes, 30 minutes, 1, 2, 4, 6, 9, and 12 hours post morning dose on Day 85 at the end of each Treatment Period •Change from Baseline in morning Peak Expiratory Flow Rate (PEFR) from paper Diary Card Time Frame: Predose at Visit 1, Baseline and upto Day 85 of each Treatment Period •Change from Baseline in trough FEV1 Time Frame: Predose, Day 1, Day 28, Day 56 and Day 85 of each Treatment Period •Change from Baseline in the percentage of symptom-free days from paper Diary Card Time Frame: Predose at Visit 1, Baseline and upto Day 85 of each Treatment Period •Change from Baseline in day- and night-time asthma symptoms from paper Diary Card Time Frame: Predose at Visit 1, Baseline and upto Day 85 of each Treatment Period •Change from Baseline in rescue medication use from paper Diary Card Time Frame: Predose at Visit 1, Baseline and upto Day 85 of each Treatment Period •Estimation of FEV1 area under the curve from 0 to 12 hours (AUC [0-12]) at Day 1 Time Frame: Predose, 15 minutes, 30 minutes, 1, 2, 4, 6, 9, and 12 hours post morning dose on Day 1 at the end of each Treatment Period | — |
Countries
Russian Federation
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed