Clinical trial NCT00384189: A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma
Official title: A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
children
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Nycomed GmbH
First posted: 2006-10-05
Enrollment: 1080
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Morning Peak Expiratory Flow (PEF)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Time to First Event of Lack of Efficacy (LOE) by Week 12
timeFrame: 12 weeks
measure: Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation
timeFrame: 28 days prior to last visit (Up to 12 Weeks)
measure: Change From Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Lung Function Variable PEF by Spirometry
timeFrame: Baseline and Week 12
measure: Change From Baseline in Morning PEF From Diary
timeFrame: Baseline and Weeks 1 thru 12
measure: Change From Baseline in Evening PEF From Diary
timeFrame: Baseline and Week 12
measure: Change From Baseline in Diurnal PEF Fluctuations
timeFrame: Baseline and Week 12
measure: Change in Asthma Symptom Total Score
timeFrame: Baseline and Week 12
measure: Change in Use of Rescue Medications
timeFrame: Baseline and Week 12
measure: Percentage of Days With Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF
timeFrame: 28 days prior to last visit (Up to 12 Weeks)
measure: Change From Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Altana Pharma/Nycomed
city: Plovdiv
country: Bulgaria
facility: Altana Pharma/Nycomed
city: Rousse
country: Bulgaria
facility: Altana Pharma/Nycomed
city: Sofia
country: Bulgaria
facility: Altana Pharma/Nycomed
city: Vama
country: Bulgaria
facility: Altana Pharma/Nycomed
city: Dresden
country: Germany
facility: Altana Pharma/Nycomed
city: Freising
country: Germany
facility: Altana Pharma/Nycomed
city: Fulda
country: Germany
facility: Altana Pharma/Nycomed
city: Homburg
country: Germany
facility: Altana Pharma/Nycomed
city: Kassel
country: Germany
facility: Altana Pharma/Nycomed
city: Leipzig
country: Germany
facility: Altana Pharma/Nycomed
city: Mannheim
country: Germany
facility: Altana Pharma/Nycomed
city: Marburg
country: Germany
facility: Altana Pharma/Nycomed
city: München
country: Germany
facility: Altana Pharma/Nycomed
city: Rosenheim
country: Germany
facility: Altana Pharma/Nycomed
city: Schwäbisch Hall
country: Germany
facility: Altana Pharma/Nycomed
city: Welzheim
country: Germany
facility: Altana Pharma/Nycomed
city: Wesel
country: Germany
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed
city: Debrecen
country: Hungary
facility: Altana Pharma/Nycomed
city: Jaszbereny
country: Hungary
facility: Altana Pharma/Nycomed
city: Kiskunhalas
country: Hungary
facility: Altana Pharma/Nycomed
city: Miskolc
country: Hungary
facility: Altana Pharma/Nycomed
city: Mosdós
country: Hungary
facility: Altana Pharma/Nycomed
city: Mosonmagyaróvár
country: Hungary
facility: Altana Pharma/Nycomed
city: Pecs
country: Hungary
facility: Altana Pharma/Nycomed
city: Szeged
country: Hungary
facility: Altana Pharma/Nycomed
city: Inowroclaw
country: Poland
facility: Altana Pharma/Nycomed
city: Lodz
country: Poland
facility: Altana Pharma/Nycomed
city: Lodz
country: Poland
facility: Altana Pharma/Nycomed
city: Lublin
country: Poland
facility: Altana Pharma/Nycomed
city: Poznan
country: Poland
facility: Altana Pharma/Nycomed
city: Torun
country: Poland
facility: Altana Pharma/Nycomed
city: Warszawa
country: Poland
facility: Altana Pharma/Nycomed
city: Warszawa
country: Poland
facility: Altana Pharma/Nycomed
city: Zawadzkie
country: Poland
facility: Altana Pharma/Nycomed
city: Brasov
country: Romania
facility: Altana Pharma/Nycomed
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed
city: Cluj-Napoca
country: Romania
facility: Altana Pharma/Nycomed
city: Cluj-Napoca
country: Romania
facility: Altana Pharma/Nycomed
city: Craiova
country: Romania
facility: Altana Pharma/Nycomed
city: Galati
country: Romania
facility: Altana Pharma/Nycomed
city: Iasi
country: Romania
facility: Altana Pharma/Nycomed
city: Sibiu
country: Romania
facility: Altana Pharma/Nycomed
city: Chelyabinsk
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Ivanovo
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Kislovodsk
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Murmansk
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Novosibirsk
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Rostov
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Samara
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Smolensk
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St.Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St.Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St.Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St.Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St.Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St.Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: St.Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Tomsk
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Vladimir
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Voronezh
country: Russian Federation
facility: Altana Pharma/Nycomed
city: Bellville - Cape Town -
country: South Africa
facility: Altana Pharma/Nycomed
city: Bloemfontein
country: South Africa
facility: Altana Pharma/Nycomed
city: Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Centurion
country: South Africa
facility: Altana Pharma/Nycomed
city: Durban, Amanzimtoti
country: South Africa
facility: Altana Pharma/Nycomed
city: Durban
country: South Africa
facility: Altana Pharma/Nycomed
city: Gezina, Pretoria
country: South Africa
facility: Altana Pharma/Nycomed
city: Morningside, Sandton
country: South Africa
facility: Altana Pharma/Nycomed
city: Mowbray, Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: New Redruth, Alberton
country: South Africa
facility: Altana Pharma/Nycomed
city: Panorama / RSA-Cape Town
country: South Africa
facility: Altana Pharma/Nycomed
city: Somerset West
country: South Africa
facility: Altana Pharma/Nycomed
city: Westville
country: South Africa
facility: Altana Pharma/Nycomed
city: Wynberg
country: South Africa
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Barcelona
country: Spain
facility: Altana Pharma/Nycomed
city: Esplugues de Llobregat
country: Spain
facility: Altana Pharma/Nycomed
city: Leganés
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Madrid
country: Spain
facility: Altana Pharma/Nycomed
city: Manresa
country: Spain
facility: Altana Pharma/Nycomed
city: Sabadell (Barcelona)
country: Spain
facility: Altana Pharma/Nycomed
city: Tarrasa
country: Spain
facility: Altana Pharma/Nycomed
city: Dnipropetrovsk
country: Ukraine
facility: Altana Pharma/Nycomed
city: Donetsk
country: Ukraine
facility: Altana Pharma/Nycomed
city: Donetsk
country: Ukraine
facility: Altana Pharma/Nycomed
city: Kharkiv
country: Ukraine
facility: Altana Pharma/Nycomed
city: Kiev
country: Ukraine
facility: Altana Pharma/Nycomed
city: Kyiv
country: Ukraine
facility: Altana Pharma/Nycomed
city: Kyiv
country: Ukraine
facility: Altana Pharma/Nycomed
city: Kyiv
country: Ukraine
facility: Altana Pharma/Nycomed
city: Lviv
country: Ukraine
facility: Altana Pharma/Nycomed
city: Odesa
country: Ukraine
facility: Altana Pharma/Nycomed
city: Poltava
country: Ukraine
facility: Altana Pharma/Nycomed
city: Simferopol
country: Ukraine
facility: Altana Pharma/Nycomed
city: Vinnytsia
country: Ukraine
facility: Altana Pharma/Nycomed
city: Zaporizhzhya
country: Ukraine
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
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.