A multicenter, randomized, double-blind, double dummy, placebo controlledcrossover study, to investigate the 24 hour FEV1 profile of a single dose of QMF Twisthaler® (500/400 µg o.d.) delivered in the evening in adult patients with persistent asthma using fluticasone propionate/salmeterol (250/50 µg b.i.d.) as an active control.

ovartis Pharma Services AG0 个研究点目标入组 39 人开始时间: 2007年8月30日最近更新: 2014年10月27日

试验速览

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•Male and female adult patients aged 18-75 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 with persistent asthma, diagnosed according to GINA guidelines and who additionally meet the following criteria:
•Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the product label, and on a stable regimen for the month prior to Visit 1.
•Patients with an FEV1 at Visit 1 of =50% of the predicted normal value. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hours during which no short acting ß2-agonist has been inhaled, and a minimum of 48 hours for a long acting ß2-agonist.
•Patients who demonstrate an increase of =12% and =200 mL in FEV1 over their prebronchodilator value within 30 minutes after inhaling a total of 200/180 µg of salbutamol/albuterol MDI (or equivalent dose of DPI) (the reversibility test).
•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

•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 who have used tobacco products within the 6 months period prior to Visit 1, or who have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
•Patients diagnosed with COPD as defined by the GOLD guidelines [Global Initiative for Chronic Obstructive Lung Disease 2006].
•Patients with seasonal allergy whose asthma is likely to deteriorate during the study period.
•Patients who have had an acute asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1.
•Patients who have had an acute asthma attack / exacerbation requiring an emergency room visit within 6 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
•Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 or at any time between Visit 1 and Visit 2.
•Patients with a history of long QT syndrome or whose QTc interval (Bazett’s) measured at Visit 1 or Visit 2 is prolonged: > 450 ms (males) or > 470 ms (females).
•Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

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