Effect of High Dose Ciclesonide on Asthma Control

Bronchial Asthma Clinical Trial

— CONTRAST  

Official title:

Control of Moderate or Severe Asthma With 160, 320 and 640 μg Ciclesonide/Day. A One-year Randomised, Double-blind, Multicenter Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455194
• Other study ID #: CL-9709-301-RD
• Secondary ID: 2011-000683-99U1
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2011
• Last updated: April 10, 2015
• Start date: November 2011
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyGermany: Federal Institute for Drugs and Medical DevicesIsrael: Ministry of HealthRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The aim of the trial is to investigate asthma control with 160 to 640 μg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

• Written informed consent was provided

• History of persistent bronchial asthma for at least 6 months

• Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 µg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks

• Good inhalation technique

• Under the current ICS pre-treatment the ACQ score ranges between = 0.75 and = 2

Exclusion Criteria:

• Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation

• Concomitant severe diseases (e.g. malignant diseases during the past 5 years [other than basal or squamous cell carcinoma], hepatitis C, acquired immune deficiency syndrome [AIDS])

• Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)

• Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Ciclesonide
During the treatment period subjects will inhale two puffs of either 40, 80 or 160 µg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 µg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Argentina,  Brazil,  Germany,  Israel,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the ACQ score from last measurement to baseline	The ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Subjects recall their experiences during the previous 7 days and respond to each question using a 7-point scale.	Baseline until end of treatment (up to 52 weeks)	No