Official Title: “A Multi-Center, Randomized, Double-Blind, Double Dummy, Placebo and Active Controlled Crossover Study, to Investigate the 24 Hour FEV1 Profile of a Single Dose of QMF Twisthaler in Adult Patients With Persistent Asthma”

This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of QMF Twisthaler compared to placebo and using fluticasone propionate/salmeterol as an active control.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Fluticasone propionate/salmeterol
  • Fluticasone/salmeterol 250/50 μg b.i.d.
• Drug: Indacaterol maleate / mometasone furoate
  • QMF Twisthaler 500/400 μg o.d.
• Drug: placebo
  • Placebo b.i.d.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2
• Active Comparator: 3

Primary Measures

• Mean change from (period) baseline FEV1 to 24 hour post-dose trough FEV1, compared with placebo.

Secondary Measures

• Efficacy/safety assessed by: Peak FEV1, FEV1 and forced vital capacity (FVC)post-dose, Standardized FEV1, area under the curve (AUC), Adverse events, laboratory, vital signs, electrocardiograms, pharmacokinetics.

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,
• Patients with persistent asthma, diagnosed according to GINA guidelines (National
• Institute of Health, National Heart, Lung and Blood Institute, 2006) 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, in a stable regimen for the month prior to Visit 1.
• Patients with an FEV1 at Visit 1 ≥50% of predicted normal.
• Patients who demonstrate an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator.

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.
• Patients diagnosed with Chronic Obstructive Pulmonary disease (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.
• Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma Study Chair Novartis  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00557440

Study ID Number: CQMF149A2202

ClinicalTrials.gov Identifier: NCT00557440

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products