adult with moderate persistent asthma
Conditions
Interventions
Trade Name: Seretide® Diskus® 50/100 µg
Product Name: Seretide Diskus 50/100 µg/dose
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Salmeterol xinafoate
Concentration unit:
Sponsors
Laboratoire GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for entry into the run-in period 1- Male or female adult aged =18 years 2- A documented clinical history of asthma 3- A documented diagnosis of asthma on lung function based on airway reversibility of =12% in the last 2 years or at visit 1 based on either FEV1 or PEF measured pre and post inhalation of 400µg salbutamol (possible to demonstrate at Visit 2 for subjects who failed to demonstrate at Visit 1) 4- A diagnosis of moderate persistent asthma defined as - daily symptoms - daily rescue use 5- Inhaled corticosteroid-naive or inhaled corticosteroid-free (i.e.; no inhaled corticosteroids for at least 12 weeks prior to Visit 1) 6- Able to use the Mini-Wright peak flow meter 7- Able to complete a DRC 8- Able to use a Diskus® correctly 9- Affiliated or a beneficiary of a social security category 10- A female is eligible to enter and participate in the study if she is: a- of a non-child-bearing potential OR b- of child bearing potential but has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study Inclusion criteria for entry into the treatment period 1- A diagnosis of moderate persistent asthma based on the DRC and defined as - daily syptoms - daily rescue use - and moderate to severe airflow limitation based on mean morning PEF between 60-80% predicted measured over the last 7 days of the run-in period on the DRC values 2- Demonstrated reversibility = 12% based on FEV1 or PEF measured pre and post-inhalation of 400 µg salbutamol for subjects who failed to demonstrate at Visit 1 3- A subject must have completed 80% of assessments on the DRC the last 7 days of the run-in period 4- For patients participating to the CT-scan sub-sudy only: if subject is of child bearing potential, a negative pregnancy urine test must be obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria for entry into the run-in period 1-Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function 2- FEV1 40 years 2- For CT scan population only: current smoker or former smoker who has stopped smoking within the 6 months before visit 1 Exclusion criteria for entry into the treatment period 1- Change in asthma medication(excluding study rescue medication) 2- Respiratory tract infection or exacerbation of asthma 3- Use of oral, parenteral or depot corticosteroids 4- Non-compliance with the completion of the DRC during the run-in 5- Subject who is pregant or lactating. Subjects should not be enrolled if they plan to become pregnant during the time of study participation (up to visit 5).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that salmeterol xinafoate/fluticasone propionate combination 50/100µg Diskus® (SFC100) on inhalation twice daily (bd) is more effective than fluticasone propionate 100µg Diskus® (FP100) bd on morning PEF, in the initial maintenance therapy of asthma in patients with moderate persistent asthma for whom a rapid control of asthma is deemed essential.;Secondary Objective: - to demonstrate that SFC100 bd is more effective than FP100 bd on FEV1 - to compare SFC100 et FP100 on time to reach first week of asthma control - to demonstrate in a sub-group of patients, that SFC100 bd is more effective than FP100 bd, in reducing air trapping (sub-group CT scan);Primary end point(s): The primary efficacy endpoint is defined as the change from baseline in mean morning PEF over weeks 5-12. Change from baseline in mean morning PEF over weeks 5-12 will be compared between treatment groups using an analysis of covariance (ANCOVA) with covariates of age, sex and baseline PEF. | — |
Countries
France
Outcome results
None listed