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CompletedNCT00163423Updated Dec 8, 2016

Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

A Phase 3 interventional study of Ciclesonide in Asthma, sponsored by AstraZeneca. Completed at 51 sites in 5 countries. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-08.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
480
Allocation
Randomized
Ages
12 Years to 75 Years
Sex
All
01

Study summary

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Ciclesonide
  • Fluticasone propionate
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 480 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  • Outpatients
  • Written informed consent
  • History of bronchial asthma for at least 6 months
  • Good health with the exception of asthma
  • Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
  • FEV1 80 - 105% of predicted

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Current smoking with more than 10 pack-years
  • Previous smoking with more than 10 pack-years
  • Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
480 participants

Interventions

  • DrugCiclesonide
06

What researchers measure

Primary outcomes

  1. FEV1

  2. time to the first asthma exacerbation.

Secondary outcomes

  1. FVC

  2. asthma symptom score

  3. use of rescue medication

  4. AQLQ(S) and EQ-5D

  5. percentage of days on which patients perceived asthma control

  6. percentage of nocturnal awakening-free days

  7. percentage of rescue medication-free days

  8. percentage of asthma symptom-free days

  9. physical examination

  10. vital signs

  11. standard laboratory work-up

  12. adverse events

  13. number of patients with local oropharyngeal adverse events.

07

Study locations

51 sites
  • Altana Pharma/Nycomed
    Gmünd, 3950, Austria
  • Altana Pharma/Nycomed
    Linz, 4020, Austria
  • Altana Pharma/Nycomed
    Linz, 4040, Austria
  • Altana Pharma/Nycomed
    Neusiedl/See, 7100, Austria
  • Altana Pharma/Nycomed
    Perg, 4320, Austria
  • Altana Pharma/Nycomed
    Steyr, 4400, Austria
  • Altana Pharma/Nycomed
    Wiener Neustadt, 2700, Austria
  • Altana Pharma/Nycomed
    Brandon, R7A 5E7, Canada
  • Altana Pharma/Nycomed
    Hamilton, L8N 3Z5, Canada
  • Altana Pharma/Nycomed
    London, N5W 6A2, Canada
  • Altana Pharma/Nycomed
    London, N6C 4Y7, Canada
  • Altana Pharma/Nycomed
    Mississauga, L5B 1N1, Canada
  • Altana Pharma/Nycomed
    Montreal, Quebec, H1V 1X5, Canada
  • Altana Pharma/Nycomed
    Montreal, H2L 4M1, Canada
  • Altana Pharma/Nycomed
    Montreal, H4J1C5, Canada
  • Altana Pharma/Nycomed
    Ottawa, K1Y 4G2, Canada
  • Altana Pharma/Nycomed
    Quebec City, G8T 7A1, Canada
  • Altana Pharma/Nycomed
    Sainte-Foy, Quebec, G1V4G5, Canada
  • Altana Pharma/Nycomed
    Sarnia, N7T 4X3, Canada
  • Altana Pharma/Nycomed
    Ste-Foy PQ, G1V 4M6, Canada
  • Altana Pharma/Nycomed
    Toronto, M4P1P2, Canada
  • Altana Pharma/Nycomed
    Woodstock, N4S 4G3, Canada
  • Altana Pharma/Nycomed
    Geesthacht, 21502, Germany
  • Altana Pharma/Nycomed
    Hannover, 30167, Germany
  • Altana Pharma/Nycomed
    Heidelberg, 69117, Germany
  • Altana Pharma/Nycomed
    Koblenz, 56068, Germany
  • Altana Pharma/Nycomed
    Mainz, 55131, Germany
  • Altana Pharma/Nycomed
    Marburg, 35037, Germany
  • Altana Pharma/Nycomed
    Sinsheim, 74889, Germany
  • Altana Pharma/Nycomed
    Witten, 58452, Germany
  • Altana Pharma/Nycomed
    Bielsko-Biala, 43316, Poland
  • Altana Pharma/Nycomed
    Gdansk, 80-847, Poland
  • Altana Pharma/Nycomed
    Lodz, 90-141, Poland
  • Altana Pharma/Nycomed
    Lubin, 59300, Poland
  • Altana Pharma/Nycomed
    Lublin, 20-718, Poland
  • Altana Pharma/Nycomed
    Lublin, 20601, Poland
  • Altana Pharma/Nycomed
    Walbrzych, 58300, Poland
  • Altana Pharma/Nycomed
    Zgierz, 95100, Poland
  • Altana Pharma/Nycomed
    Arcadia, Pretoria, 132, South Africa
  • Altana Pharma/Nycomed
    Bellville, Cape Town, 7530, South Africa
  • Altana Pharma/Nycomed
    Cape Town, Tygerberg, 7505, South Africa
  • Altana Pharma/Nycomed
    Cape Town, 7764, South Africa
  • Altana Pharma/Nycomed
    Durbanville / Cape Town, 7550, South Africa
  • Altana Pharma/Nycomed
    Gatesville, Cape Town, 7764, South Africa
  • Altana Pharma/Nycomed
    Lyttleton, 140, South Africa
  • Altana Pharma/Nycomed
    Mowbray, Cape Town, 7925, South Africa
  • Altana Pharma/Nycomed
    Observatory Cape, 7925, South Africa
  • Altana Pharma/Nycomed
    Pretoria, 181, South Africa
  • Altana Pharma/Nycomed
    Pretoria, 2, South Africa
  • Altana Pharma/Nycomed
    Westville, 3630, South Africa
  • Altana Pharma/Nycomed
    Wynberg, 7945, South Africa
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00163423
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Sep 14, 2005
Start date
Nov 2004
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Dec 8, 2016

Study contacts

AstraZeneca AstraZeneca
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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