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

NCT00384189 | Completed Phase 3 Results

• 2 other identifiers: BY9010/M1-209U1111-1172-2297
• Study Type: interventional
• Target: 1,080
• Locations: 9 countries
• Sites: 122

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.

Conditions

Asthma

Keywords

Asthma; Ciclesonide; children

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (12)

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

  12 weeks

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

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

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

  Baseline and Week 12

• Change From Baseline in Lung Function Variable PEF by Spirometry

  Baseline and Week 12

• Change From Baseline in Morning PEF From Diary

  Baseline and Weeks 1 thru 12

Study Arms (4)

Ciclesonide 40 µg

ACTIVE COMPARATOR

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.

Drug: Ciclesonide; Drug: Placebo; Drug: Salbutamol

Ciclesonide 80 µg

ACTIVE COMPARATOR

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.

Drug: Ciclesonide; Drug: Placebo; Drug: Salbutamol

Ciclesonide 160 µg

ACTIVE COMPARATOR

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.

Drug: Ciclesonide; Drug: Placebo; Drug: Salbutamol

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo; Drug: Salbutamol

Interventions

Ciclesonide DRUG

inhaled Ciclesonide

Ciclesonide 160 µg; Ciclesonide 40 µg; Ciclesonide 80 µg

Placebo DRUG

Ciclesonide placebo-matching inhaler

Ciclesonide 160 µg; Ciclesonide 40 µg; Ciclesonide 80 µg; Placebo

Salbutamol DRUG

Salbutamol inhalation powder

Ciclesonide 160 µg; Ciclesonide 40 µg; Ciclesonide 80 µg; Placebo

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to follow the procedures of the study

Sponsors & Collaborators

• AstraZeneca: lead
• Nycomed GmbH: collaborator

Study Sites (122)

Altana Pharma/Nycomed

Plovdiv, 4000, Bulgaria

Location

Altana Pharma/Nycomed

Plovdiv, 4002, Bulgaria

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Altana Pharma/Nycomed

Rousse, 7004, Bulgaria

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Altana Pharma/Nycomed

Sofia, 1431, Bulgaria

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Altana Pharma/Nycomed

Vama, 9010, Bulgaria

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Altana Pharma/Nycomed

Dresden, 1067, Germany

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Altana Pharma/Nycomed

Freising, 85354, Germany

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Altana Pharma/Nycomed

Fulda, 36039, Germany

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Altana Pharma/Nycomed

Homburg, 66424, Germany

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Altana Pharma/Nycomed

Kassel, 34121, Germany

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Altana Pharma/Nycomed

Leipzig, 4207, Germany

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Altana Pharma/Nycomed

Mannheim, 68167, Germany

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Altana Pharma/Nycomed

Marburg, 35037, Germany

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Altana Pharma/Nycomed

München, 80939, Germany

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Altana Pharma/Nycomed

Rosenheim, 83026, Germany

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Altana Pharma/Nycomed

Schwäbisch Hall, 74523, Germany

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Altana Pharma/Nycomed

Welzheim, 73642, Germany

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Altana Pharma/Nycomed

Wesel, 46483, Germany

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Altana Pharma/Nycomed

Budapest, 1089, Hungary

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Altana Pharma/Nycomed

Budapest, 1121, Hungary

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Altana Pharma/Nycomed

Debrecen, 4012, Hungary

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Altana Pharma/Nycomed

Jászberény, 5100, Hungary

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Altana Pharma/Nycomed

Kiskunhalas, 6400, Hungary

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Altana Pharma/Nycomed

Miskolc, 3501, Hungary

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Altana Pharma/Nycomed

Mosdós, 7257, Hungary

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Altana Pharma/Nycomed

Mosonmagyaróvár, 9200, Hungary

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Altana Pharma/Nycomed

Pécs, 7624, Hungary

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Altana Pharma/Nycomed

Szeged, 6720, Hungary

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Altana Pharma/Nycomed

Inowrocław, 88-100, Poland

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Altana Pharma/Nycomed

Lodz, 90-141, Poland

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Altana Pharma/Nycomed

Lodz, 93-513, Poland

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Altana Pharma/Nycomed

Lublin, 20-093, Poland

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Altana Pharma/Nycomed

Poznan, 60-693, Poland

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Altana Pharma/Nycomed

Torun, 87-100, Poland

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Altana Pharma/Nycomed

Warsaw, 01-211, Poland

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Altana Pharma/Nycomed

Warsaw, 03-924, Poland

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Altana Pharma/Nycomed

Zawadzkie, 46-059, Poland

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Altana Pharma/Nycomed

Brasov, 500063, Romania

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Altana Pharma/Nycomed

Bucharest, 11025, Romania

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Altana Pharma/Nycomed

Bucharest, 11743, Romania

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Altana Pharma/Nycomed

Bucharest, 20395, Romania

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Altana Pharma/Nycomed

Bucharest, 22102, Romania

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Altana Pharma/Nycomed

Bucharest, 22444, Romania

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Altana Pharma/Nycomed

Bucharest, 41451, Romania

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Altana Pharma/Nycomed

Cluj-Napoca, 400217, Romania

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Altana Pharma/Nycomed

Cluj-Napoca, 400371, Romania

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Altana Pharma/Nycomed

Craiova, 200341, Romania

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Altana Pharma/Nycomed

Galati, 800487, Romania

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Altana Pharma/Nycomed

Iași, 700309, Romania

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Altana Pharma/Nycomed

Sibiu, 550166, Romania

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Altana Pharma/Nycomed

Chelyabinsk, Russia

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Altana Pharma/Nycomed

Ivanovo, Russia

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Altana Pharma/Nycomed

Kislovodsk, 357703, Russia

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Altana Pharma/Nycomed

Moscow, 105077, Russia

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Altana Pharma/Nycomed

Moscow, 115446, Russia

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Altana Pharma/Nycomed

Moscow, 115478, Russia

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Altana Pharma/Nycomed

Moscow, 117513, Russia

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Altana Pharma/Nycomed

Moscow, 119049, Russia

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Altana Pharma/Nycomed

Moscow, 119526, Russia

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Altana Pharma/Nycomed

Moscow, 119991, Russia

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Altana Pharma/Nycomed

Moscow, 125412, Russia

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Altana Pharma/Nycomed

Moscow, 129090, Russia

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Altana Pharma/Nycomed

Moscow, Russia

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Altana Pharma/Nycomed

Murmansk, 183047, Russia

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Altana Pharma/Nycomed

Novosibirsk, 630091, Russia

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Altana Pharma/Nycomed

Rostov, 1344068, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 191036, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 191123, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 192212, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 193144, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 194100, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 194156, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 196084, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 196650, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 198205, Russia

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Altana Pharma/Nycomed

Saint Petersburg, 199053, Russia

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Altana Pharma/Nycomed

Saint Petersburg, Russia

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Altana Pharma/Nycomed

Samara, 443000, Russia

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Altana Pharma/Nycomed

Smolensk, Russia

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Altana Pharma/Nycomed

Tomsk, Russia

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Altana Pharma/Nycomed

Vladimir, Russia

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Altana Pharma/Nycomed

Voronezh, Russia

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Altana Pharma/Nycomed

Bellville - Cape Town -, 7530, South Africa

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Altana Pharma/Nycomed

Bloemfontein, 9301, South Africa

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Altana Pharma/Nycomed

Cape Town, 7937, South Africa

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Altana Pharma/Nycomed

Centurion, 157, South Africa

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Altana Pharma/Nycomed

Durban, 3630, South Africa

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Altana Pharma/Nycomed

Durban, Amanzimtoti, 4126, South Africa

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Altana Pharma/Nycomed

Gezina, Pretoria, 84, South Africa

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Altana Pharma/Nycomed

Morningside, Sandton, 2196, South Africa

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Altana Pharma/Nycomed

Mowbray, Cape Town, 7925, South Africa

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Altana Pharma/Nycomed

New Redruth, Alberton, 1450, South Africa

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Altana Pharma/Nycomed

Panorama / RSA-Cape Town, 7500, South Africa

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Altana Pharma/Nycomed

Somerset West, 7130, South Africa

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Altana Pharma/Nycomed

Westville, 3630, South Africa

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Altana Pharma/Nycomed

Wynberg, 7945, South Africa

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Altana Pharma/Nycomed

Barcelona, 8003, Spain

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Altana Pharma/Nycomed

Barcelona, 8035, Spain

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Altana Pharma/Nycomed

Barcelona, 8222, Spain

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Altana Pharma/Nycomed

Esplugues de Llobregat, 8950, Spain

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Altana Pharma/Nycomed

Leganés, 28911, Spain

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Altana Pharma/Nycomed

Madrid, 28006, Spain

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Altana Pharma/Nycomed

Madrid, 28009, Spain

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Altana Pharma/Nycomed

Madrid, 28040, Spain

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Altana Pharma/Nycomed

Madrid, 28041, Spain

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Altana Pharma/Nycomed

Manresa, 8240, Spain

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Altana Pharma/Nycomed

Sabadell (Barcelona), 8208, Spain

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Altana Pharma/Nycomed

Tarrasa, 8211, Spain

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Altana Pharma/Nycomed

Dnipropetrovsk, 49101, Ukraine

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Altana Pharma/Nycomed

Donetsk, 83017, Ukraine

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Altana Pharma/Nycomed

Donetsk, 83045, Ukraine

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Altana Pharma/Nycomed

Kharkiv, 61051, Ukraine

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Altana Pharma/Nycomed

Kiev, 3680, Ukraine

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Altana Pharma/Nycomed

Kyiv, 1135, Ukraine

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Altana Pharma/Nycomed

Kyiv, 2125, Ukraine

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Altana Pharma/Nycomed

Kyiv, 4050, Ukraine

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Altana Pharma/Nycomed

Lviv, 79059, Ukraine

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Altana Pharma/Nycomed

Odesa, 65031, Ukraine

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Altana Pharma/Nycomed

Poltava, 36011, Ukraine

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Altana Pharma/Nycomed

Simferopol, 95004, Ukraine

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Altana Pharma/Nycomed

Vinnytsia, Ukraine

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Altana Pharma/Nycomed

Zaporizhzhya, 69063, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 20619624 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: AstraZeneca Clinical Study Information Center
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 5, 2006
• Study Start: September 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2008
• Last Updated: February 1, 2017
• Results First Posted: August 16, 2016

Record last verified: 2016-10

Locations

DE (13); RU (32); ES (12); UA (14); RO (13); PL (9); BU (5); ZA (14); HU (10)