NCT00163410

Brief Summary

The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent 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 (12 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
500

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

16 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

April 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 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

December 2, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

September 12, 2005

Last Update Submit

December 1, 2016

Conditions

Asthma

Keywords

AsthmaCiclesonideChildFluticasone propionatePediatric

Outcome Measures

Primary Outcomes (1)

  • FEV1 absolute values.

Secondary Outcomes (14)

  • FEV1 as % of predicted

  • PEF from spirometry

  • diary based morning and evening PEF

  • diary based symptom score

  • diary based salbutamol MDI use

  • +9 more secondary outcomes

Interventions

CiclesonideDRUG

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • History of persistent bronchial asthma for at least 6 months
  • FEV1 50-90% of predicted

You may not qualify if:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
  • History of life-threatening asthma
  • Premature birth
  • Current smoking
  • Smoking history with either equal or more than 10 pack-years
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Altana Pharma/Nycomed

Ahmedabad, 380 018, India

Location

Altana Pharma/Nycomed

Bangalore, 560 034, India

Location

Altana Pharma/Nycomed

Chandigarh, 160 012, India

Location

Altana Pharma/Nycomed

Coimbatore, 641 004, India

Location

Altana Pharma/Nycomed

Coimbatore, 641 014, India

Location

Altana Pharma/Nycomed

Coimbatore, Tamilnadu, 641 044, India

Location

Altana Pharma/Nycomed

Delhi, 110 007, India

Location

Altana Pharma/Nycomed

Kolkata, 700091, India

Location

Altana Pharma/Nycomed

Mumbai, 400 004, India

Location

Altana Pharma/Nycomed

Mumbai, 400 012, India

Location

Altana Pharma/Nycomed

Mumbai, 400 022, India

Location

Altana Pharma/Nycomed

Mumbai, 400 026, India

Location

Altana Pharma/Nycomed

Pune, 411 001, India

Location

Altana Pharma/Nycomed

Pune, 411 030, India

Location

Altana Pharma/Nycomed

Pune, 411 033, India

Location

Altana Pharma/Nycomed

Shastri Nagar, Jaipur, 302 016, India

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

April 1, 2003

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

December 2, 2016

Record last verified: 2016-12

Locations

IN(16)