Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of QMF Twisthaler (Indacaterol Maleate/Mometasone Furoate)
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Fluticasone propionate/salmeterol (Drug); Indacaterol maleate / mometasone furoate (Drug); placebo (Drug)
Phase: Phase 2
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Pharma, Study Chair, Affiliation: Novartis
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.
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Mean change from (period) baseline FEV1 to 24 hour post-dose trough FEV1, compared with placebo.
Secondary outcome: 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.
Minimum age: 18 Years.
Maximum age: 75 Years.
- 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
- 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
- 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
- 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
- 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.
Locations and Contacts
Novartis Investigator site, Ghent, Belgium
Novartis Investigator Site, Aalst, Belgium
Novartis Investigator Site, Landsberg, Germany
Novartis Investigator Site, berlin, Germany
Novartis Investigator Site, Hannover, Germany
Novartis Investigator Site, Rostock, Germany
Starting date: November 2007
Ending date: June 2008
Last updated: June 4, 2008