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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2016
• Main ID: NCT00314509
• Date of registration: 11/04/2006
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
• Scientific title: 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
• Date of first enrolment: July 2005
• Target sample size: 240
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00314509
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France, Germany, Hungary, South Africa

Contacts

• Name: AstraZeneca AstraZeneca
• Affiliation: AstraZeneca

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Ciclesonide/Formoterol Combination

Primary Outcome(s)

AUC (FEV1) over a 24 h dosing interval.

Time to the first experience of lack of efficacy

Secondary Outcome(s)

FEV1

morning and evening PEF, asthma symptoms and use of rescue medication

proportion of patients with a clinical asthma exacerbation.

Secondary ID(s)

BY9010/M1-506

Source(s) of Monetary Support

Please refer to primary and secondary sponsors