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

Sponsors

Lead Sponsor: AstraZeneca

Source AstraZeneca
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.

Overall Status Completed
Start Date 2005-07-01
Completion Date 2006-01-01
Primary Completion Date 2006-01-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to the first experience of lack of efficacy
AUC (FEV1) over a 24 h dosing interval.
Secondary Outcome
Measure Time Frame
FEV1
morning and evening PEF, asthma symptoms and use of rescue medication
proportion of patients with a clinical asthma exacerbation.
Enrollment 240
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ciclesonide/Formoterol Combination

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
AstraZeneca AstraZeneca Study Director AstraZeneca
Location
Facility:
Altana Pharma/Nycomed | Grenoble, 38100, France
Altana Pharma/Nycomed | Montpellier, 34295, France
Altana Pharma/Nycomed | Berlin, 14050, Germany
Altana Pharma/Nycomed | Großhansdorf, 22927, Germany
Altana Pharma/Nycomed | Mainz, 55131, Germany
Altana Pharma/Nycomed | Rüdersdorf, 15562, Germany
Altana Pharma/Nycomed | Wiesbaden, 65187, Germany
Altana Pharma/Nycomed | Balassagyarmat, 2660, Hungary
Altana Pharma/Nycomed | Balatonfüred, 8230, Hungary
Altana Pharma/Nycomed | Budapest, 1125, Hungary
Altana Pharma/Nycomed | Budapest, 1529, Hungary
Altana Pharma/Nycomed | Csorna, 9300, Hungary
Altana Pharma/Nycomed | Debrecen, 4043, Hungary
Altana Pharma/Nycomed | Györ, 9024, Hungary
Altana Pharma/Nycomed | Matrahaza, 3233, Hungary
Altana Pharma/Nycomed | Mosonmagyaróvár, 9200, Hungary
Altana Pharma/Nycomed | Nyíregyháza, 4400, Hungary
Altana Pharma/Nycomed | Szolnok, 5006, Hungary
Altana Pharma/Nycomed | Szombathely, 9700, Hungary
Altana Pharma/Nycomed | Arcadia, Pretoria, 132, South Africa
Altana Pharma/Nycomed | Bellville, Cape Town, 7530, South Africa
Altana Pharma/Nycomed | Bloemfontein, 9300, South Africa
Altana Pharma/Nycomed | Cape Town, Tygerberg, 7505, South Africa
Altana Pharma/Nycomed | Mowbray, Cape Town, 7925, South Africa
Altana Pharma/Nycomed | Panorama / RSA-Cape Town, 7500, South Africa
Altana Pharma/Nycomed | Pretoria, South Africa
Location Countries

France

Germany

Hungary

South Africa

Verification Date

2016-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

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