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

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314509
• Other study ID #: BY9010/M1-506
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2006
• Last updated: December 2, 2016
• Start date: July 2005
• Est. completion date: January 2006

Study information

• Verified date: December 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide/Formoterol Combination

Locations

Country	Name	City	State
France	Altana Pharma/Nycomed	Grenoble
France	Altana Pharma/Nycomed	Montpellier
Germany	Altana Pharma/Nycomed	Berlin
Germany	Altana Pharma/Nycomed	Großhansdorf
Germany	Altana Pharma/Nycomed	Mainz
Germany	Altana Pharma/Nycomed	Rüdersdorf
Germany	Altana Pharma/Nycomed	Wiesbaden
Hungary	Altana Pharma/Nycomed	Balassagyarmat
Hungary	Altana Pharma/Nycomed	Balatonfüred
Hungary	Altana Pharma/Nycomed	Budapest
Hungary	Altana Pharma/Nycomed	Budapest
Hungary	Altana Pharma/Nycomed	Csorna
Hungary	Altana Pharma/Nycomed	Debrecen
Hungary	Altana Pharma/Nycomed	Györ
Hungary	Altana Pharma/Nycomed	Matrahaza
Hungary	Altana Pharma/Nycomed	Mosonmagyaróvár
Hungary	Altana Pharma/Nycomed	Nyíregyháza
Hungary	Altana Pharma/Nycomed	Szolnok
Hungary	Altana Pharma/Nycomed	Szombathely
South Africa	Altana Pharma/Nycomed	Arcadia, Pretoria
South Africa	Altana Pharma/Nycomed	Bellville, Cape Town
South Africa	Altana Pharma/Nycomed	Bloemfontein
South Africa	Altana Pharma/Nycomed	Cape Town, Tygerberg
South Africa	Altana Pharma/Nycomed	Mowbray, Cape Town
South Africa	Altana Pharma/Nycomed	Panorama / RSA-Cape Town
South Africa	Altana Pharma/Nycomed	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

France,  Germany,  Hungary,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the first experience of lack of efficacy
Primary	AUC (FEV1) over a 24 h dosing interval.
Secondary	FEV1
Secondary	morning and evening PEF, asthma symptoms and use of rescue medication
Secondary	proportion of patients with a clinical asthma exacerbation.

External Links

•   BY9010 M1-506.pdf