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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 Points

Forced 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

Page last updated: August 23, 2015

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