Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)

NCT00163436 | Completed Phase 3

• 1 other identifier: BY9010/M1-145
• Study Type: interventional
• Target: 450
• Locations: 6 countries
• Sites: 66

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).

Conditions

Asthma

Keywords

Asthma; Ciclesonide

Outcome Measures

Primary Outcomes (1)

• FEV1.

Secondary Outcomes (15)

• FVC

• morning and evening PEF from diaries

• asthma symptom score

• use of rescue medication

• number of patients with an asthma exacerbation

Interventions

Ciclesonide DRUG

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (66)

Altana Pharma/Nycomed

La Malbaie, Quebec, G5A 1W7, Canada

Location

Altana Pharma/Nycomed

London, N6A 5R9, Canada

Location

Altana Pharma/Nycomed

London,ON, N6A1V2, Canada

Location

Altana Pharma/Nycomed

Mississauga, L5B 1N1, Canada

Location

Altana Pharma/Nycomed

Montreal, Quebec, H1V 1X5, Canada

Location

Altana Pharma/Nycomed

Québec, G8T 7A1, Canada

Location

Altana Pharma/Nycomed

Richmond Hill, L4S 1P3, Canada

Location

Altana Pharma/Nycomed

Sainte-Foy, Quebec, G1V4G5, Canada

Location

Altana Pharma/Nycomed

Saskatoon,SK, S7H 0W2, Canada

Location

Altana Pharma/Nycomed

Scarborough,ON, M1B 4Z8, Canada

Location

Altana Pharma/Nycomed

Toronto, M4P1P2, Canada

Location

Altana Pharma/Nycomed

Vancouver, BC, V5Z 4E1, Canada

Location

Altana Pharma/Nycomed

Winnipeg, R2M 5L9, Canada

Location

Altana Pharma/Nycomed

Winnipeg MB, R3C 0N2, Canada

Location

Altana Pharma/Nycomed

Woodstock, N4S 4G3, Canada

Location

Altana Pharma/Nycomed

Aix-en-Provence, 13090, France

Location

Altana Pharma/Nycomed

Chauny, 2303, France

Location

Altana Pharma/Nycomed

Ferolles-Attily, 77150, France

Location

Altana Pharma/Nycomed

Grasse, 6130, France

Location

Altana Pharma/Nycomed

La Rochelle, 17000, France

Location

Altana Pharma/Nycomed

La Teste-de-Buch, 33260, France

Location

Altana Pharma/Nycomed

Libourne, 33500, France

Location

Altana Pharma/Nycomed

Lille, 59000, France

Location

Altana Pharma/Nycomed

Martigues, 13695, France

Location

Altana Pharma/Nycomed

Montbrison, 42600, France

Location

Altana Pharma/Nycomed

Montpellier, 34070, France

Location

Altana Pharma/Nycomed

Nice, 6000, France

Location

Altana Pharma/Nycomed

Nîmes, 30900, France

Location

Altana Pharma/Nycomed

Saint-Laurent-du-Var, 6700, France

Location

Altana Pharma/Nycomed

Saint-Quentin, 2100, France

Location

Altana Pharma/Nycomed

Berlin, 10717, Germany

Location

Altana Pharma/Nycomed

Berlin, 13597, Germany

Location

Altana Pharma/Nycomed

Oschersleben, 39387, Germany

Location

Altana Pharma/Nycomed

Rüdersdorf, 15562, Germany

Location

Altana Pharma/Nycomed

Schwetzingen, 68723, Germany

Location

Altana Pharma/Nycomed

Weinheim, 69469, Germany

Location

Altana Pharma/Nycomed

Balassagyarmat, 2660, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1121, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1134, Hungary

Location

Altana Pharma/Nycomed

Budapet, 1529, Hungary

Location

Altana Pharma/Nycomed

Érd, 2030, Hungary

Location

Altana Pharma/Nycomed

Gyula, 5703, Hungary

Location

Altana Pharma/Nycomed

Komárom, 2900, Hungary

Location

Altana Pharma/Nycomed

Miskolc, 3501, Hungary

Location

Altana Pharma/Nycomed

Mosdós, 7257, Hungary

Location

Altana Pharma/Nycomed

Nyiregyháza, 4412, Hungary

Location

Altana Pharma/Nycomed

Pécs, 7621, Hungary

Location

Altana Pharma/Nycomed

Szeged, 6722, Hungary

Location

Altana Pharma/Nycomed

Székesfehérvár, 8000, Hungary

Location

Altana Pharma/Nycomed

Bangalore, 560 034, India

Location

Altana Pharma/Nycomed

Chennai, 600 034, India

Location

Altana Pharma/Nycomed

Coimbatore, 641 014, India

Location

Altana Pharma/Nycomed

Coimbatore, 641004, India

Location

Altana Pharma/Nycomed

Coimbatore, Tamilnadu, 641 044, India

Location

Altana Pharma/Nycomed

Goa, 403 002, India

Location

Altana Pharma/Nycomed

Kalaburagi, 585105, India

Location

Altana Pharma/Nycomed

Mumbai, 400008, India

Location

Altana Pharma/Nycomed

Mumbai, Dadar (E), 400 014, India

Location

Altana Pharma/Nycomed

Pune, India

Location

Altana Pharma/Nycomed

Florence, 50134, Italy

Location

Altana Pharma/Nycomed

Milan, 20122, Italy

Location

Altana Pharma/Nycomed

Milan, 20142, Italy

Location

Altana Pharma/Nycomed

Milan, 20153, Italy

Location

Altana Pharma/Nycomed

Napoli, 80131, Italy

Location

Altana Pharma/Nycomed

Pordenone, 33170, Italy

Location

Altana Pharma/Nycomed

Verona, 30012, Italy

Location

Related Links

• BY9010-MI-145-RDS-2007-05-21.pdf

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: November 30, 2016

Record last verified: 2016-10

Locations

DE (6); CA (15); HU (13); IN (10); FR (15); IT (7)