A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma (RAINBOW)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Ciclesonide; Drug: Placebo; Drug: Salbutamol

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00384189

BY9010/M1-209

U1111-1172-2297 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.

Full description

The drug being tested is called ciclesonide. This study looked at the safety and efficacy of inhaled ciclesonide in children with asthma. The study enrolled 1080 patients.

Participants were randomly assigned to 1 of 4 treatment groups which were undisclosed to the patient and study doctor during the study:• Ciclesonide 40 µg, 80 µg or 160 µg • Placebo- this is similar to study drug but has no active ingredient. Ciclesonide was inhaled via a metered-dose inhaler (MDI with HFA-134a propellant), with or without spacer, once daily in the evening throughout the study. All participants were asked to document daily AM and PM peak expiratory flow (PEF), daytime and nighttime asthma symptom scores and number of puffs of rescue medicine in an electronic diary. This multi-centre trial was conducted worldwide. The overall time to participate in this study was 20 weeks. Participants made multiple visits to the clinic plus a final visit 30 days after the last dose of study drug for a follow-up assessment.

Enrollment: 1,080 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• History of asthma for at least 6 months
• Ability to show optimal use of MDI, including inhalation technique
• Lung function and reversibility within specified limits

Main Exclusion Criteria:

• Concomitant severe diseases
• Diseases which are contraindications for the use of inhaled steroids
• Two or more inpatient hospitalizations for asthma within the last year
• Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
• Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks)
• Beginning of or change in immunotherapy within the last 6 months prior to inclusion
• Inability to follow the procedures of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,080 participants in 4 patient groups, including a placebo group

Ciclesonide 40 µg

Active Comparator group

Description:

Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

Treatment:

Drug: Placebo

Drug: Ciclesonide

Drug: Salbutamol

Ciclesonide 80 µg

Active Comparator group

Description:

Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

Treatment:

Drug: Placebo

Drug: Ciclesonide

Drug: Salbutamol

Ciclesonide 160 µg

Active Comparator group

Description:

Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

Treatment:

Drug: Placebo

Drug: Ciclesonide

Drug: Salbutamol

Placebo

Placebo Comparator group

Description:

Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

Treatment:

Drug: Placebo

Drug: Salbutamol