Clinical trial NCT00163436: Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)
Official title: Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 450
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).


Eligibility criteria: Main Inclusion Criteria:

* Written informed consent
* History of persistent bronchial asthma for at least 6 months
* Good health with the exception of asthma

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Smoking history with ≥10 cigarette pack years
* Pregnancy
* Intention to become pregnant
* Breast feeding
* Lack of safe contraception
* Previous enrolment into the current study

Primary outcomes:
measure: FEV1.
Secondary outcomes:
measure: FVC
measure: morning and evening PEF from diaries
measure: asthma symptom score
measure: use of rescue medication
measure: number of patients with an asthma exacerbation
measure: time to the first asthma exacerbation
measure: percentage of days on which patient perceived asthma control
measure: percentage of nocturnal awakening-free days
measure: percentage of rescue medication-free days
measure: percentage of asthma symptom-free days
measure: adverse events
measure: physical examination
measure: vital signs
measure: standard laboratory work-up
measure: 8 am serum cortisol.
Other outcomes:
Locations:
city: La Malbaie, Quebec
country: Canada
facility: Altana Pharma/Nycomed
city: London,ON
country: Canada
facility: Altana Pharma/Nycomed
city: London
country: Canada
facility: Altana Pharma/Nycomed
city: Mississauga
country: Canada
facility: Altana Pharma/Nycomed
city: Montreal, Quebec
country: Canada
facility: Altana Pharma/Nycomed
city: Quebec City
country: Canada
facility: Altana Pharma/Nycomed
city: Richmond Hill
country: Canada
facility: Altana Pharma/Nycomed
city: Sainte-Foy, Quebec
country: Canada
facility: Altana Pharma/Nycomed
city: Saskatoon,SK
country: Canada
facility: Altana Pharma/Nycomed
city: Scarborough,ON
country: Canada
facility: Altana Pharma/Nycomed
city: Toronto
country: Canada
facility: Altana Pharma/Nycomed
city: Vancouver, BC
country: Canada
facility: Altana Pharma/Nycomed
city: Winnipeg MB
country: Canada
facility: Altana Pharma/Nycomed
city: Winnipeg
country: Canada
facility: Altana Pharma/Nycomed
city: Woodstock
country: Canada
facility: Altana Pharma/Nycomed
city: Aix En Provence
country: France
facility: Altana Pharma/Nycomed
city: Chauny CEDEX
country: France
facility: Altana Pharma/Nycomed
city: Ferolles-Attily
country: France
facility: Altana Pharma/Nycomed
city: Grasse
country: France
facility: Altana Pharma/Nycomed
city: La Rochelle
country: France
facility: Altana Pharma/Nycomed
city: La Teste de Buch
country: France
facility: Altana Pharma/Nycomed
city: Libourne
country: France
facility: Altana Pharma/Nycomed
city: Lille
country: France
facility: Altana Pharma/Nycomed
city: Martigues Cedex
country: France
facility: Altana Pharma/Nycomed
city: Montbrison
country: France
facility: Altana Pharma/Nycomed
city: Montpellier Cedex
country: France
facility: Altana Pharma/Nycomed
city: Nice
country: France
facility: Altana Pharma/Nycomed
city: Nimes
country: France
facility: Altana Pharma/Nycomed
city: Saint Laurent Du Var
country: France
facility: Altana Pharma/Nycomed
city: Saint-Quentin
country: France
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Berlin
country: Germany
facility: Altana Pharma/Nycomed
city: Oschersleben
country: Germany
facility: Altana Pharma/Nycomed
city: Rüdersdorf
country: Germany
facility: Altana Pharma/Nycomed
city: Schwetzingen
country: Germany
facility: Altana Pharma/Nycomed
city: Weinheim
country: Germany
facility: Altana Pharma/Nycomed
city: Balassagyarmat
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapet
country: Hungary
facility: Altana Pharma/Nycomed
city: Gyula
country: Hungary
facility: Altana Pharma/Nycomed
city: Komárom
country: Hungary
facility: Altana Pharma/Nycomed
city: Miskolc
country: Hungary
facility: Altana Pharma/Nycomed
city: Mosdós
country: Hungary
facility: Altana Pharma/Nycomed
city: Nyiregyháza
country: Hungary
facility: Altana Pharma/Nycomed
city: Pécs
country: Hungary
facility: Altana Pharma/Nycomed
city: Szeged
country: Hungary
facility: Altana Pharma/Nycomed
city: Székesfehérvár
country: Hungary
facility: Altana Pharma/Nycomed
city: Érd
country: Hungary
facility: Altana Pharma/Nycomed
city: Bangalore
country: India
facility: Altana Pharma/Nycomed
city: Chennai
country: India
facility: Altana Pharma/Nycomed
city: Coimbatore, Tamilnadu
country: India
facility: Altana Pharma/Nycomed
city: Coimbatore
country: India
facility: Altana Pharma/Nycomed
city: Coimbatore
country: India
facility: Altana Pharma/Nycomed
city: Goa
country: India
facility: Altana Pharma/Nycomed
city: Gulbarga
country: India
facility: Altana Pharma/Nycomed
city: Mumbai, Dadar (E)
country: India
facility: Altana Pharma/Nycomed
city: Mumbai
country: India
facility: Altana Pharma/Nycomed
city: Pune
country: India
facility: Altana Pharma/Nycomed
city: Firenze
country: Italy
facility: Altana Pharma/Nycomed
city: Milano
country: Italy
facility: Altana Pharma/Nycomed
city: Milano
country: Italy
facility: Altana Pharma/Nycomed
city: Milano
country: Italy
facility: Altana Pharma/Nycomed
city: Napoli
country: Italy
facility: Altana Pharma/Nycomed
city: Pordenone
country: Italy
facility: Altana Pharma/Nycomed
city: Verona
country: Italy
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: