Clinical trial NCT00314509: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Formoterol Fumarate
Long-acting beta2-agonists
LABA
Steroids
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Time to the first experience of lack of efficacy
measure: AUC (FEV1) over a 24 h dosing interval.
Secondary outcomes:
measure: FEV1
measure: morning and evening PEF, asthma symptoms and use of rescue medication
measure: proportion of patients with a clinical asthma exacerbation.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Altana Pharma/Nycomed
city: Montpellier
country: France
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Großhansdorf
country: Germany
facility: Altana Pharma/Nycomed
city: Mainz
country: Germany
facility: Altana Pharma/Nycomed
city: Rüdersdorf
country: Germany
facility: Altana Pharma/Nycomed
city: Wiesbaden
country: Germany
facility: Altana Pharma/Nycomed
city: Balassagyarmat
country: Hungary
facility: Altana Pharma/Nycomed
city: Balatonfüred
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Csorna
country: Hungary
facility: Altana Pharma/Nycomed
city: Debrecen
country: Hungary
facility: Altana Pharma/Nycomed
city: Györ
country: Hungary
facility: Altana Pharma/Nycomed
city: Matrahaza
country: Hungary
facility: Altana Pharma/Nycomed
city: Mosonmagyaróvár
country: Hungary
facility: Altana Pharma/Nycomed
city: Nyíregyháza
country: Hungary
facility: Altana Pharma/Nycomed
city: Szolnok
country: Hungary
facility: Altana Pharma/Nycomed
city: Szombathely
country: Hungary
facility: Altana Pharma/Nycomed
city: Arcadia, Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
city: Bellville, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Bloemfontein
country: South Africa
facility: Altana Pharma/Nycomed
city: Cape Town, Tygerberg
country: South Africa
facility: Altana Pharma/Nycomed
city: Mowbray, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Panorama / RSA-Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: