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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ciclesonide; Formoterol Fumarate

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