NCT00305461

Brief Summary

The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Feb 2006

Typical duration for phase_3 asthma

Geographic Reach
1 country

12 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

February 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

December 5, 2016

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

March 21, 2006

Last Update Submit

December 2, 2016

Conditions

Asthma

Keywords

AsthmaQuality of LifeCiclesonide

Outcome Measures

Primary Outcomes (3)

  • differences in Quality of Life from AQLQ(S) (T end versus T0)

    8 weeks

  • time to first exacerbation

    8 weeks

  • differences in FEV1 and FVC from spirometry (T end vs T0).

    8 weeks

Secondary Outcomes (9)

  • percentage of days on which patients perceived asthma control

    8 weeks

  • percentage of asthma symptoms free days

    8 weeks

  • percentage of rescue medication-free days

    8 weeks

  • percentage of nocturnal awakening-free days

    8 weeks

  • asthma symptom score (daytime score, nighttime score, total score)

    8 weeks

  • +4 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Ciclesonide 160µg

Drug: Ciclesonide

2

ACTIVE COMPARATOR

Ciclesonide 320µg

Drug: Ciclesonide

Interventions

CiclesonideDRUG

Effect of Ciclesonide on Quality of Life

12

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Good health with the exception of asthma
  • Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0
  • Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication
  • FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0
  • Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol
  • Patients compliant to recommended pre-treatment

You may not qualify if:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • Chronic obstructive pulmonary disease (COPD)
  • Hospitalization within previous four weeks from baseline
  • Hospitalization due to asthma within the last twelve months
  • Asthma exacerbation within two months previous to baseline
  • History of almost fatal asthma at any moment
  • Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
  • Exacerbation of asthma within 2 months prior to entry into the baseline period
  • Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Altana Pharma/Nycomed

Buenos Aires, B1902CSK, Argentina

Location

Altana Pharma/Nycomed

Buenos Aires, B7540GHQ, Argentina

Location

Altana Pharma/Nycomed

Buenos Aires, B8000AAT, Argentina

Location

Altana Pharma/Nycomed

Cap. Fed., C1117ABE, Argentina

Location

Altana Pharma/Nycomed

Cap. Fed., C1121ABE, Argentina

Location

Altana Pharma/Nycomed

Cap. Fed., C1221ADC, Argentina

Location

Altana Pharma/Nycomed

Cap. Fed., C1427ARN, Argentina

Location

Altana Pharma/Nycomed

Córdoba, X5000BFB, Argentina

Location

Altana Pharma/Nycomed

Córdoba, X5016KEH, Argentina

Location

Altana Pharma/Nycomed

Mendoza, M5500CCG, Argentina

Location

Altana Pharma/Nycomed

San Miguel de Tucumán, T4146DAL, Argentina

Location

Altana Pharma/Nycomed

Santa Fe, S2000DSV, Argentina

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
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 22, 2006

Study Start

February 1, 2006

Primary Completion

March 1, 2007

Study Completion

February 1, 2008

Last Updated

December 5, 2016

Record last verified: 2016-09

Locations

AR(12)