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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ciclesonide

Placebo

Salbutamol

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Ciclesonide, children

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ciclesonide 40 µg

Ciclesonide 80 µg

Ciclesonide 160 µg

Placebo

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Morning Peak Expiratory Flow (PEF)

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward.

Secondary Outcome Measures

Time to First Event of Lack of Efficacy (LOE) by Week 12

Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period.

Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation

Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented.

Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)

Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function.

Change From Baseline in Lung Function Variable PEF by Spirometry

Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function.

Change From Baseline in Morning PEF From Diary

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.

Change From Baseline in Evening PEF From Diary

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.

Change From Baseline in Diurnal PEF Fluctuations

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.

Change in Asthma Symptom Total Score

Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0(best) to 4 (worst). A negative change from Baseline indicated improvement.

Change in Use of Rescue Medications

The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement.

Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF

Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF. The median percentage of days with asthma control is presented.

Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score

PAQLQS is a disease specific instrument to assess the impact of asthma on the patient's quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.

Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall

PACQLQ assesses the impact of the child's asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.

Full Information

NCT ID

NCT00384189

First Posted

October 4, 2006

Last Updated

December 2, 2016

Sponsor

AstraZeneca

Collaborators

Nycomed GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00384189

Brief Title

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

Acronym

RAINBOW

Official Title

A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Nycomed GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Ciclesonide, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1080 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ciclesonide 40 µg

Arm Type

Active Comparator

Arm Description

Arm Title

Ciclesonide 80 µg

Arm Type

Active Comparator

Arm Description

Arm Title

Ciclesonide 160 µg

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ciclesonide

Intervention Description

inhaled Ciclesonide

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Ciclesonide placebo-matching inhaler

Intervention Type

Drug

Intervention Name(s)

Salbutamol

Intervention Description

Salbutamol inhalation powder

Primary Outcome Measure Information:

Title

Change From Baseline in Morning Peak Expiratory Flow (PEF)

Description

Time Frame

Baseline and Week 12

Secondary Outcome Measure Information:

Title

Time to First Event of Lack of Efficacy (LOE) by Week 12

Description

Time Frame

12 weeks

Title

Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation

Description

Time Frame

28 days prior to last visit (Up to 12 Weeks)

Title

Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)

Description

Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function.

Time Frame

Baseline and Week 12

Title

Change From Baseline in Lung Function Variable PEF by Spirometry

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in Morning PEF From Diary

Description

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.

Time Frame

Baseline and Weeks 1 thru 12

Title

Change From Baseline in Evening PEF From Diary

Description

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.

Time Frame

Baseline and Week 12

Title

Change From Baseline in Diurnal PEF Fluctuations

Description

PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.

Time Frame

Baseline and Week 12

Title

Change in Asthma Symptom Total Score

Description

Time Frame

Baseline and Week 12

Title

Change in Use of Rescue Medications

Description

The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement.

Time Frame

Baseline and Week 12

Title

Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF

Description

Time Frame

28 days prior to last visit (Up to 12 Weeks)

Title

Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score

Description

Time Frame

Baseline and Week 12

Title

Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall

Description

Time Frame

Baseline and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AstraZeneca AstraZeneca

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Altana Pharma/Nycomed

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Altana Pharma/Nycomed

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Altana Pharma/Nycomed

City

Rousse

ZIP/Postal Code

7004

Country

Bulgaria

Facility Name

Altana Pharma/Nycomed

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Altana Pharma/Nycomed

City

Vama

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Altana Pharma/Nycomed

City

Dresden

ZIP/Postal Code

1067

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Freising

ZIP/Postal Code

85354

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Fulda

ZIP/Postal Code

36039

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Homburg

ZIP/Postal Code

66424

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Leipzig

ZIP/Postal Code

4207

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

München

ZIP/Postal Code

80939

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Rosenheim

ZIP/Postal Code

83026

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Schwäbisch Hall

ZIP/Postal Code

74523

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Welzheim

ZIP/Postal Code

73642

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Wesel

ZIP/Postal Code

46483

Country

Germany

Facility Name

Altana Pharma/Nycomed

City

Budapest

ZIP/Postal Code

1089

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Jaszbereny

ZIP/Postal Code

5100

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Kiskunhalas

ZIP/Postal Code

6400

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Miskolc

ZIP/Postal Code

3501

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Mosdós

ZIP/Postal Code

7257

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Mosonmagyaróvár

ZIP/Postal Code

9200

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Altana Pharma/Nycomed

City

Inowroclaw

ZIP/Postal Code

88-100

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Lodz

ZIP/Postal Code

90-141

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Poznan

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Warszawa

ZIP/Postal Code

01-211

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Warszawa

ZIP/Postal Code

03-924

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Zawadzkie

ZIP/Postal Code

46-059

Country

Poland

Facility Name

Altana Pharma/Nycomed

City

Brasov

ZIP/Postal Code

500063

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Bucharest

ZIP/Postal Code

11025

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Bucharest

ZIP/Postal Code

11743

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Bucharest

ZIP/Postal Code

20395

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Bucharest

ZIP/Postal Code

22102

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Bucharest

ZIP/Postal Code

22444

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Bucharest

ZIP/Postal Code

41451

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Cluj-Napoca

ZIP/Postal Code

400217

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Cluj-Napoca

ZIP/Postal Code

400371

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Craiova

ZIP/Postal Code

200341

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Galati

ZIP/Postal Code

800487

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Iasi

ZIP/Postal Code

700309

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Sibiu

ZIP/Postal Code

550166

Country

Romania

Facility Name

Altana Pharma/Nycomed

City

Chelyabinsk

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Ivanovo

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Kislovodsk

ZIP/Postal Code

357703

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

105077

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

115446

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

117513

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

119526

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

119991

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

125412

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

ZIP/Postal Code

129090

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Moscow

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Murmansk

ZIP/Postal Code

183047

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Rostov

ZIP/Postal Code

1344068

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Samara

ZIP/Postal Code

443000

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Smolensk

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St. Petersburg

ZIP/Postal Code

191123

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St. Petersburg

ZIP/Postal Code

192212

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St. Petersburg

ZIP/Postal Code

194100

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St. Petersburg

ZIP/Postal Code

196650

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St. Petersburg

ZIP/Postal Code

199053

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St.Petersburg

ZIP/Postal Code

191036

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St.Petersburg

ZIP/Postal Code

193144

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St.Petersburg

ZIP/Postal Code

194100

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St.Petersburg

ZIP/Postal Code

194156

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St.Petersburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St.Petersburg

ZIP/Postal Code

198205

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

St.Petersburg

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Tomsk

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Vladimir

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Voronezh

Country

Russian Federation

Facility Name

Altana Pharma/Nycomed

City

Bellville - Cape Town -

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Cape Town

ZIP/Postal Code

7937

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Centurion

ZIP/Postal Code

157

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Durban, Amanzimtoti

ZIP/Postal Code

4126

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Durban

ZIP/Postal Code

3630

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Gezina, Pretoria

ZIP/Postal Code

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Morningside, Sandton

ZIP/Postal Code

2196

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Mowbray, Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

New Redruth, Alberton

ZIP/Postal Code

1450

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Panorama / RSA-Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Westville

ZIP/Postal Code

3630

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Wynberg

ZIP/Postal Code

7945

Country

South Africa

Facility Name

Altana Pharma/Nycomed

City

Barcelona

ZIP/Postal Code

8003

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Barcelona

ZIP/Postal Code

8222

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Esplugues de Llobregat

ZIP/Postal Code

8950

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Leganés

ZIP/Postal Code

28911

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Manresa

ZIP/Postal Code

8240

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Sabadell (Barcelona)

ZIP/Postal Code

8208

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Tarrasa

ZIP/Postal Code

8211

Country

Spain

Facility Name

Altana Pharma/Nycomed

City

Dnipropetrovsk

ZIP/Postal Code

49101

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Donetsk

ZIP/Postal Code

83017

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Donetsk

ZIP/Postal Code

83045

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Kharkiv

ZIP/Postal Code

61051

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Kiev

ZIP/Postal Code

3680

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Kyiv

ZIP/Postal Code

1135

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Kyiv

ZIP/Postal Code

2125

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Kyiv

ZIP/Postal Code

4050

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Lviv

ZIP/Postal Code

79059

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Odesa

ZIP/Postal Code

65031

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Simferopol

ZIP/Postal Code

95004

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Vinnytsia

Country

Ukraine

Facility Name

Altana Pharma/Nycomed

City

Zaporizhzhya

ZIP/Postal Code

69063

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

20619624

Citation

Pedersen S, Potter P, Dachev S, Bosheva M, Kaczmarek J, Springer E, Dunkel J, Engelstatter R. Efficacy and safety of three ciclesonide doses vs placebo in children with asthma: the RAINBOW study. Respir Med. 2010 Nov;104(11):1618-28. doi: 10.1016/j.rmed.2010.06.012. Epub 2010 Jul 8.

Results Reference

derived

Learn more about this trial

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

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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial