NCT00314509

Brief Summary

The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2 asthma

Geographic Reach
4 countries

26 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

July 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

6 months

First QC Date

April 11, 2006

Last Update Submit

December 2, 2016

Conditions

Asthma

Keywords

AsthmaCiclesonideFormoterol FumarateLong-acting beta2-agonistsLABASteroids

Outcome Measures

Primary Outcomes (2)

  • Time to the first experience of lack of efficacy

  • AUC (FEV1) over a 24 h dosing interval.

Secondary Outcomes (3)

  • FEV1

  • morning and evening PEF, asthma symptoms and use of rescue medication

  • proportion of patients with a clinical asthma exacerbation.

Interventions

Ciclesonide/Formoterol CombinationDRUG

Eligibility Criteria

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

You may qualify if:

  • Written informed consent
  • Good health with the exception of bronchial asthma (for at least 6 months)
  • FEV1 \> 60% to \< 80% of predicted (if pretreated with inhaled steroids only)
  • FEV1 \> 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller)

You may not qualify if:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists
  • Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function
  • Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years
  • Use of other drugs not allowed
  • Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Altana Pharma/Nycomed

Grenoble, 38100, France

Location

Altana Pharma/Nycomed

Montpellier, 34295, France

Location

Altana Pharma/Nycomed

Berlin, 14050, Germany

Location

Altana Pharma/Nycomed

Großhansdorf, 22927, Germany

Location

Altana Pharma/Nycomed

Mainz, 55131, Germany

Location

Altana Pharma/Nycomed

Rüdersdorf, 15562, Germany

Location

Altana Pharma/Nycomed

Wiesbaden, 65187, Germany

Location

Altana Pharma/Nycomed

Balassagyarmat, 2660, Hungary

Location

Altana Pharma/Nycomed

Balatonfüred, 8230, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1125, Hungary

Location

Altana Pharma/Nycomed

Budapest, 1529, Hungary

Location

Altana Pharma/Nycomed

Csorna, 9300, Hungary

Location

Altana Pharma/Nycomed

Debrecen, 4043, Hungary

Location

Altana Pharma/Nycomed

Győr, 9024, Hungary

Location

Altana Pharma/Nycomed

Mátraháza, 3233, Hungary

Location

Altana Pharma/Nycomed

Mosonmagyaróvár, 9200, Hungary

Location

Altana Pharma/Nycomed

Nyíregyháza, 4400, Hungary

Location

Altana Pharma/Nycomed

Szolnok, 5006, Hungary

Location

Altana Pharma/Nycomed

Szombathely, 9700, Hungary

Location

Altana Pharma/Nycomed

Arcadia, Pretoria, 132, South Africa

Location

Altana Pharma/Nycomed

Bellville, Cape Town, 7530, South Africa

Location

Altana Pharma/Nycomed

Bloemfontein, 9300, South Africa

Location

Altana Pharma/Nycomed

Cape Town, Tygerberg, 7505, South Africa

Location

Altana Pharma/Nycomed

Mowbray, Cape Town, 7925, South Africa

Location

Altana Pharma/Nycomed

Panorama / RSA-Cape Town, 7500, South Africa

Location

Altana Pharma/Nycomed

Pretoria, South Africa

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 14, 2006

Study Start

July 1, 2005

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

December 5, 2016

Record last verified: 2016-12

Locations

FR(2)ZA(7)DE(5)HU(12)