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.

• Conditions: Patients with persistent asthma, diagnosed according to GINA guidelines [National Institute of Health., National Heart, Lung and Blood Institute, 2006]; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2007-003192-39-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-30
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• 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

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified