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

NCT ID: NCT00384189

Last Updated: 2017-02-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ciclesonide 40 µg

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.

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

inhaled Ciclesonide

Placebo

Intervention Type DRUG

Ciclesonide placebo-matching inhaler

Salbutamol

Intervention Type DRUG

Salbutamol inhalation powder

Ciclesonide 80 µg

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.

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

inhaled Ciclesonide

Placebo

Intervention Type DRUG

Ciclesonide placebo-matching inhaler

Salbutamol

Intervention Type DRUG

Salbutamol inhalation powder

Ciclesonide 160 µg

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.

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

inhaled Ciclesonide

Placebo

Intervention Type DRUG

Ciclesonide placebo-matching inhaler

Salbutamol

Intervention Type DRUG

Salbutamol inhalation powder

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ciclesonide placebo-matching inhaler

Salbutamol

Intervention Type DRUG

Salbutamol inhalation powder

Interventions

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Ciclesonide

inhaled Ciclesonide

Intervention Type DRUG

Placebo

Ciclesonide placebo-matching inhaler

Intervention Type DRUG

Salbutamol

Salbutamol inhalation powder

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nycomed GmbH

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Altana Pharma/Nycomed

Plovdiv, , Bulgaria

Site Status

Altana Pharma/Nycomed

Plovdiv, , Bulgaria

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Altana Pharma/Nycomed

Rousse, , Bulgaria

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Altana Pharma/Nycomed

Sofia, , Bulgaria

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Altana Pharma/Nycomed

Vama, , Bulgaria

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Altana Pharma/Nycomed

Dresden, , Germany

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Altana Pharma/Nycomed

Freising, , Germany

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Altana Pharma/Nycomed

Fulda, , Germany

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Altana Pharma/Nycomed

Homburg, , Germany

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Altana Pharma/Nycomed

Kassel, , Germany

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Altana Pharma/Nycomed

Leipzig, , Germany

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Altana Pharma/Nycomed

Mannheim, , Germany

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Altana Pharma/Nycomed

Marburg, , Germany

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Altana Pharma/Nycomed

München, , Germany

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Altana Pharma/Nycomed

Rosenheim, , Germany

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Altana Pharma/Nycomed

Schwäbisch Hall, , Germany

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Altana Pharma/Nycomed

Welzheim, , Germany

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Altana Pharma/Nycomed

Wesel, , Germany

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Altana Pharma/Nycomed

Budapest, , Hungary

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Altana Pharma/Nycomed

Budapest, , Hungary

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Altana Pharma/Nycomed

Debrecen, , Hungary

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Altana Pharma/Nycomed

Jászberény, , Hungary

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Altana Pharma/Nycomed

Kiskunhalas, , Hungary

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Altana Pharma/Nycomed

Miskolc, , Hungary

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Altana Pharma/Nycomed

Mosdós, , Hungary

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Altana Pharma/Nycomed

Mosonmagyaróvár, , Hungary

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Altana Pharma/Nycomed

Pécs, , Hungary

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Altana Pharma/Nycomed

Szeged, , Hungary

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Altana Pharma/Nycomed

Inowrocław, , Poland

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Altana Pharma/Nycomed

Lodz, , Poland

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Altana Pharma/Nycomed

Lodz, , Poland

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Altana Pharma/Nycomed

Lublin, , Poland

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Altana Pharma/Nycomed

Poznan, , Poland

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Altana Pharma/Nycomed

Torun, , Poland

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Altana Pharma/Nycomed

Warsaw, , Poland

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Altana Pharma/Nycomed

Warsaw, , Poland

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Altana Pharma/Nycomed

Zawadzkie, , Poland

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Altana Pharma/Nycomed

Brasov, , Romania

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Altana Pharma/Nycomed

Bucharest, , Romania

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Altana Pharma/Nycomed

Bucharest, , Romania

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Altana Pharma/Nycomed

Bucharest, , Romania

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Altana Pharma/Nycomed

Bucharest, , Romania

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Altana Pharma/Nycomed

Bucharest, , Romania

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Altana Pharma/Nycomed

Bucharest, , Romania

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Altana Pharma/Nycomed

Cluj-Napoca, , Romania

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Altana Pharma/Nycomed

Cluj-Napoca, , Romania

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Altana Pharma/Nycomed

Craiova, , Romania

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Altana Pharma/Nycomed

Galati, , Romania

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Altana Pharma/Nycomed

Iași, , Romania

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Altana Pharma/Nycomed

Sibiu, , 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, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Moscow, , Russia

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Altana Pharma/Nycomed

Murmansk, , Russia

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Altana Pharma/Nycomed

Novosibirsk, , Russia

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Altana Pharma/Nycomed

Rostov, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Saint Petersburg, , Russia

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Altana Pharma/Nycomed

Samara, , 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 -, , South Africa

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Altana Pharma/Nycomed

Bloemfontein, , South Africa

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Altana Pharma/Nycomed

Cape Town, , South Africa

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Altana Pharma/Nycomed

Centurion, , South Africa

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Altana Pharma/Nycomed

Durban, , South Africa

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Altana Pharma/Nycomed

Durban, Amanzimtoti, , South Africa

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Altana Pharma/Nycomed

Gezina, Pretoria, , South Africa

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Altana Pharma/Nycomed

Morningside, Sandton, , South Africa

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Altana Pharma/Nycomed

Mowbray, Cape Town, , South Africa

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Altana Pharma/Nycomed

New Redruth, Alberton, , South Africa

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Altana Pharma/Nycomed

Panorama / RSA-Cape Town, , South Africa

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Altana Pharma/Nycomed

Somerset West, , South Africa

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Altana Pharma/Nycomed

Westville, , South Africa

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Altana Pharma/Nycomed

Wynberg, , South Africa

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Altana Pharma/Nycomed

Barcelona, , Spain

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Altana Pharma/Nycomed

Barcelona, , Spain

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Altana Pharma/Nycomed

Barcelona, , Spain

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Altana Pharma/Nycomed

Esplugues de Llobregat, , Spain

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Altana Pharma/Nycomed

Leganés, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Madrid, , Spain

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Altana Pharma/Nycomed

Manresa, , Spain

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Altana Pharma/Nycomed

Sabadell (Barcelona), , Spain

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Altana Pharma/Nycomed

Tarrasa, , Spain

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Altana Pharma/Nycomed

Dnipropetrovsk, , Ukraine

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Altana Pharma/Nycomed

Donetsk, , Ukraine

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Altana Pharma/Nycomed

Donetsk, , Ukraine

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Altana Pharma/Nycomed

Kharkiv, , Ukraine

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Altana Pharma/Nycomed

Kiev, , Ukraine

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Altana Pharma/Nycomed

Kyiv, , Ukraine

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Altana Pharma/Nycomed

Kyiv, , Ukraine

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Altana Pharma/Nycomed

Kyiv, , Ukraine

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Altana Pharma/Nycomed

Lviv, , Ukraine

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Altana Pharma/Nycomed

Odesa, , Ukraine

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Altana Pharma/Nycomed

Poltava, , Ukraine

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Altana Pharma/Nycomed

Simferopol, , Ukraine

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Altana Pharma/Nycomed

Vinnytsia, , Ukraine

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Altana Pharma/Nycomed

Zaporizhzhya, , Ukraine

Site Status

Countries

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Bulgaria Germany Hungary Poland Romania Russia South Africa Spain Ukraine

References

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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.

Reference Type DERIVED
PMID: 20619624 (View on PubMed)

Other Identifiers

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U1111-1172-2297

Identifier Type: REGISTRY

Identifier Source: secondary_id

BY9010/M1-209

Identifier Type: -

Identifier Source: org_study_id

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