Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone propionate/salmeterol (Drug); indacaterol maleate / mometasone furoate (Drug); placebo to indacaterol/mometasone (Drug); placebo to fluticasone propionate/salmeterol (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Pharma, Study Chair, Affiliation: Novartis Pharmaceuticals
Summary
This study is designed to provide data about the 24 hours FEV1 profile, safety and
tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using
fluticasone/salmeterol as an active control.
Clinical Details
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 Device in Adult Patients With Persistent Asthma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
Secondary outcome: Forced Expiratory Volume in 1 Second (FEV1) at Single Time PointsForced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose Time to Peak Forced Expiratory Volume in 1 Second (FEV1) Forced Vital Capacity (FVC) at Single Time Points
Eligibility
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 Global Initiative for Asthma
(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 interval syndrome or whose QT interval corrected
for heart rate (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, Aalst, Belgium
Novartis Investigator site, Ghent, Belgium
Novartis Investigator Site, Berlin, Germany
Novartis Investigator Site, Hannover, Germany
Novartis Investigator Site, Landsberg, Germany
Novartis Investigator Site, Rostock, Germany
Additional Information
Starting date: November 2007
Last updated: February 15, 2013
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