Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)

Novartis50 enrolled

Overview

This study is designed to demonstrate that formoterol 12µg and 24µg delivered by a new inhalation device (Concept1) are equivalent to the corresponding dose of formoterol delivered by the Aerolizer device in terms of efficacy, in patients with persistent asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

formoterolDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of asthma attacks * Forced expiratory volume in 1 second (measure of how well the lungs are working) is greater than 60% of the predicted value Exclusion Criteria: * Asthma is not stable: patients were admitted to hospital or received emergency room treatment * Patients whose asthma drugs need changing within the month prior to the start of the study

Locations (4)

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bovenden--Lengler, Germany

Novartis Investigative Site

Marburg, Germany

Novartis Investigative Site

Wiesbaden, Germany

Outcomes

Primary Outcomes

• Efficacy assessed by 12 hour Area Under the Curve (AUC) of FEV1 (forced expiratory volume in 1 second, is a measure of how well the lungs are working)

Secondary Outcomes

• Efficacy assessed by forced expiratory volume in 1 second at pre-dose, 15, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours post dose

Data from ClinicalTrials.gov

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