persistent asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Indacaterol Twisthaler
Pharmaceutical Form: Inhalation powder
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adult and adolescent patients aged 12-75 years (inclusive), who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to Visit 1. Patients below the legal age of consent are required to have the Informed Consent Form signed by the patient’s parent / guardian. 2. Patients with asthma, diagnosed according to GINA guidelines (2006) Are the trial subjects under 18? yes 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: -Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception. -Patients with asthma, or current smokers, or patients who have used tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. -Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose response relationship among four doses of indacaterol Twisthaler® (62.5, 125, 250, and 500 µg o.d.) and placebo as measured by the mean change from baseline to 24 hr post-dose of (trough) FEV1 after 14 days of treatment. (Baseline FEV1 is defined as the average of two FEV1 assessments taken at 50 min and 15 min before the first study drug administration. Trough FEV1 is defined as the mean of 2 measurements at 23 hr 10 min and 23 hr 45 min post-dose).;Primary end point(s): The primary endpoint is trough FEV1, specificallu the mean change from baseline to 24 hr post dose (trough) FEV1 after 14 days of treatment.; Secondary Objective: Efficacy • To assess the bronchodilator effect four doses of indacaterol Twisthaler® in patients with persistent asthma compared to placebo • Morning and evening PEF measurements for indacaterol Twisthaler® in comparison to placebo. • To assess day and night time rescue medication usage for indacaterol Twisthaler® in comparison to placebo. • To estimate the effects of treatment between formoterol and placebo for all of the efficacy variables above Safety • To assess the safety of multiple doses of indacaterol Twisthaler® in patients with persistent asthma by comparing four doses in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs and ECGs. • To assess the safety of formoterol in patients with persistent asthma in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs and ECGs. | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Poland, Slovakia, Spain, United Kingdom
Outcome results
None listed