Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of QMF Twisthaler (Indacaterol Maleate/Mometasone Furoate)

Condition(s) targeted: Asthma

Intervention: Fluticasone propionate/salmeterol (Drug); Indacaterol maleate / mometasone furoate (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

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. Gender(s): Both.

Criteria:

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.

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