Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)

ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314509

Enrollment

240

Registered

2006-04-14

Start date

2005-07-31

Completion date

2006-01-31

Last updated

2016-12-05

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

Conditions

Asthma

Keywords

Asthma, Ciclesonide, Formoterol Fumarate, Long-acting beta2-agonists, LABA, Steroids

Brief summary

The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.

Interventions

DRUGCiclesonide/Formoterol Combination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * Written informed consent * Good health with the exception of bronchial asthma (for at least 6 months) * FEV1 \> 60% to \< 80% of predicted (if pretreated with inhaled steroids only) * FEV1 \> 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller) Main

Exclusion criteria

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists * Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function * Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years * Use of other drugs not allowed * Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential

Design outcomes

Primary

Measure	Time frame
Time to the first experience of lack of efficacy	—
AUC (FEV1) over a 24 h dosing interval.	—

Secondary

Measure	Time frame
FEV1	—
morning and evening PEF, asthma symptoms and use of rescue medication	—
proportion of patients with a clinical asthma exacerbation.	—

Countries

France, Germany, Hungary, South Africa

Outcome results

None listed

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