Back to resultsSafety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ciclesonide/Formoterol Combination
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Ciclesonide, Formoterol Fumarate, Long-acting beta2-agonists, LABA, Steroids
Eligibility 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
Sites / Locations
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
Outcomes
Primary Outcome Measures
Time to the first experience of lack of efficacy
AUC (FEV1) over a 24 h dosing interval.
Secondary Outcome Measures
FEV1
morning and evening PEF, asthma symptoms and use of rescue medication
proportion of patients with a clinical asthma exacerbation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00314509
Brief Title
Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Ciclesonide, Formoterol Fumarate, Long-acting beta2-agonists, LABA, Steroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciclesonide/Formoterol Combination
Primary Outcome Measure Information:
Title
Time to the first experience of lack of efficacy
Title
AUC (FEV1) over a 24 h dosing interval.
Secondary Outcome Measure Information:
Title
FEV1
Title
morning and evening PEF, asthma symptoms and use of rescue medication
Title
proportion of patients with a clinical asthma exacerbation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
Grenoble
ZIP/Postal Code
38100
Country
France
Facility Name
Altana Pharma/Nycomed
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Altana Pharma/Nycomed
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Rüdersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Altana Pharma/Nycomed
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Csorna
ZIP/Postal Code
9300
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szolnok
ZIP/Postal Code
5006
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Altana Pharma/Nycomed
City
Arcadia, Pretoria
ZIP/Postal Code
132
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Bellville, Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Cape Town, Tygerberg
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Mowbray, Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Panorama / RSA-Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Altana Pharma/Nycomed
City
Pretoria
Country
South Africa
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4546&filename=BY9010%20M1-506.pdf
Description
BY9010 M1-506.pdf
Learn more about this trial
Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
We'll reach out to this number within 24 hrs