NCT00163397

Brief Summary

The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Jan 2004

Geographic Reach
2 countries

6 active sites

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

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

November 30, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

September 12, 2005

Last Update Submit

November 29, 2016

Conditions

Asthma

Keywords

AsthmaCiclesonideBudesonide

Outcome Measures

Primary Outcomes (1)

  • FEV1 absolute values.

Secondary Outcomes (18)

  • FEV1 as percent of predicted

  • FVC

  • PEF absolute values

  • morning and evening PEF from diary

  • diurnal PEF fluctuation

  • +13 more secondary outcomes

Interventions

CiclesonideDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
  • FEV1 80 - 105% of predicted
  • Healthy with the exception of asthma
  • Written informed consent has been obtained
  • Outpatients
  • Patients who have a history of persistent bronchial asthma for at least 6 months

You may not qualify if:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
  • Patient is current smoker with 10 or more pack-years
  • Patient is ex-smoker with 10 or more pack-years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Altana Pharma/Nycomed

Kota Bharu / Kelantan, 16150, Malaysia

Location

Altana Pharma/Nycomed

Kuala Lumpur, 50586, Malaysia

Location

Altana Pharma/Nycomed

Kuala Lumpur, 50603, Malaysia

Location

Altana Pharma/Nycomed

Kuala Lumpur, 56000, Malaysia

Location

Altana Pharma/Nycomed

Taipei, 886-114, Taiwan

Location

Altana Pharma/Nycomed

Taipei, Taiwan

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

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

Study Officials

  • AstraZeneca AstraZeneca

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
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

January 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

November 30, 2016

Record last verified: 2016-10

Locations

TW(2)MY(4)