Effect of High Dose Ciclesonide on Asthma Control (CONTRAST)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Bronchial Asthma

Treatments: Drug: Ciclesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455194

2011-000683-99 (EudraCT Number)

U1111-1133-6333 (Registry Identifier)

CL-9709-301-RDCTID (Registry Identifier)

CL-9709-301-RD

Details and patient eligibility

About

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

Enrollment: 520 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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520 participants in 3 patient groups

CIC 160

Active Comparator group

Description:

Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg)

Treatment:

Drug: Ciclesonide

CIC 320

Active Comparator group

Description:

Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg)

Treatment:

Drug: Ciclesonide

CIC 640

Active Comparator group

Description:

Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg)

Treatment:

Drug: Ciclesonide