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

A Randomized, Multi-centre, Double-blind, Double Dummy Placebo Controlled Single-dose Cross-over Study to Demonstrate That 12 and 24 µg of Formoterol Delivered by Concept1 Has a Bronchodilator Efficacy Which is Equivalent to the Same Dose of Formoterol Delivered by Aerolizer in Adult Patients With Persistent Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00443482

Enrollment

Registered

2007-03-06

Start date

2007-02-28

Completion date

2007-05-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, adults, B2 agonist, formoterol

Brief summary

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.

Interventions

DRUGformoterol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
• 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

Measure	Time frame
• 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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026