NCT00392288

Brief Summary

Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma. Secondary objective: To assess the safety and tolerability of ciclesonide.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
528

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Sep 2006

Geographic Reach
6 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

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 30, 2009

Completed
Last Updated

February 1, 2017

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

October 24, 2006

Results QC Date

July 1, 2009

Last Update Submit

December 2, 2016

Conditions

Asthma

Keywords

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.

    Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to \<12 years only. Least Squares Mean were adjusted for Baseline FEV1, age \[yrs\], pooled center, previous corticosteroid therapy and holding chamber.

    Baseline and Week 12

Secondary Outcomes (2)

  • Change From Baseline in Total Daily Asthma Symptom Score at Week 12.

    Baseline and Week 12

  • Change From Baseline in Use of Albuterol/Salbutamol at Week 12.

    Baseline and Week 12

Study Arms (3)

Placebo MDI

PLACEBO COMPARATOR

double-blind

Drug: Placebo

Ciclesonide MDI 40 µg BID

EXPERIMENTAL

double-blind

Drug: Ciclesonide

Ciclesonide MDI 80 µg BID

EXPERIMENTAL

double-blind

Drug: Ciclesonide

Interventions

CiclesonideDRUG

Ciclesonide MDI 40 µg BID over twelve weeks

Ciclesonide MDI 40 µg BID
PlaceboDRUG

Placebo MDI over twelve weeks

Placebo MDI

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • History of persistent bronchial asthma for at least 3 months prior to screening;
  • For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
  • For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
  • Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
  • Only patients aged between 6 to \<12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol

You may not qualify if:

  • Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
  • Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
  • Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
  • History of life-threatening asthma, including a history of significant hypercarbia (pCO2 \>45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
  • More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
  • Use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

sanofi-aventis, US

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Hungaria

Budapest, Hungary

Location

Sanofi-Aventis

México, Mexico

Location

sanofi-aventis Poland

Warsaw, Poland

Location

Sanofi-Aventis Administrative Office

Moscow, Russia

Location

sanofi-aventis South Africa

Midrand, South Africa

Location

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 25, 2006

Study Start

September 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 1, 2017

Results First Posted

December 30, 2009

Record last verified: 2016-09

Locations

US(1)ME(1)PL(1)ZA(1)RU(1)HU(1)