NCT00306163

Brief Summary

The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started May 2006

Typical duration for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 26, 2010

Completed
Last Updated

February 1, 2017

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

March 22, 2006

Results QC Date

April 6, 2010

Last Update Submit

December 2, 2016

Conditions

Asthma

Keywords

AsthmaAMPCiclesonideFluticasone propionate

Outcome Measures

Primary Outcomes (1)

  • PC20 AMP (Post-treatment Compared to Baseline)

    Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron

    Baseline and 5 weeks

Secondary Outcomes (2)

  • Δ (FVC/SVC) at PC20 (AMP)

    Baseline and 5 weeks

  • Safety and Tolerability

    5 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Ciclesonide 160 µg

Drug: Ciclesonide

2

ACTIVE COMPARATOR

Fluticasone 100 µg

Drug: Fluticasone

Interventions

CiclesonideDRUG

inhaled Ciclesonide 160 µg, once daily in the morning

1
FluticasoneDRUG

inhaled Fluticasone 100 µg, twice daily

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of bronchial asthma
  • FEV1 \> 1.20 L
  • Positive Skin Prick Test
  • Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit

You may not qualify if:

  • Clinically relevant abnormal laboratory values
  • Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
  • Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
  • One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
  • Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
  • Positive response to saline challenge at baseline visits
  • Positive bronchial hyperresponsiveness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altana Pharma/Nycomed

RB Groningen, 9700, Netherlands

Location

Related Publications (1)

  • Cohen J, Postma DS, Douma WR, Vonk JM, De Boer AH, ten Hacken NH. Particle size matters: diagnostics and treatment of small airways involvement in asthma. Eur Respir J. 2011 Mar;37(3):532-40. doi: 10.1183/09031936.00204109. Epub 2010 Jul 1.

    PMID: 20595155DERIVED

MeSH Terms

Conditions

Asthma

Interventions

ciclesonideFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
AstraZeneca Clinical Study Information Center
Organization
AstraZeneca
information.center@astrazeneca.com
1-877-240-9479

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 23, 2006

Study Start

May 1, 2006

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

February 1, 2017

Results First Posted

April 26, 2010

Record last verified: 2016-09

Locations

NL(1)