Effect of High Dose Ciclesonide on Asthma Control (CONTRAST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01455194
First received: October 17, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

The aim of the trial is to investigate asthma control with 160 to 640 μg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).


Condition Intervention Phase
Bronchial Asthma
Drug: Ciclesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Control of Moderate or Severe Asthma With 160, 320 and 640 μg Ciclesonide/Day. A One-year Randomised, Double-blind, Multicenter Trial.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change in the ACQ score from last measurement to baseline [ Time Frame: Baseline until end of treatment (up to 52 weeks) ] [ Designated as safety issue: No ]
    The ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Subjects recall their experiences during the previous 7 days and respond to each question using a 7-point scale.


Estimated Enrollment: 450
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CIC 160
Two puffs of 40 µg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 µg)
Drug: Ciclesonide
During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
Active Comparator: CIC 320
Two puffs of 80 µg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 µg)
Drug: Ciclesonide
During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
Active Comparator: CIC 640
Two puffs of 160 µg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 µg)
Drug: Ciclesonide
During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent was provided
  • History of persistent bronchial asthma for at least 6 months
  • Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks
  • Good inhalation technique
  • Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2

Exclusion Criteria:

  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
  • Concomitant severe diseases (e.g. malignant diseases during the past 5 years [other than basal or squamous cell carcinoma], hepatitis C, acquired immune deficiency syndrome [AIDS])
  • Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
  • Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455194

Locations
Argentina
Nycomed Investigational Site
Capital Federal, Buenos Aires, Argentina, C1425BEN
Nycomed Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1426ABP
Nycomed Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1015ABO
Nycomed Investigational Site
Rosario, Argentina, 2000
Nycomed Investigational Site
Rosario-Santa Fe, Argentina, S2000KZD
Nycomed Investigational Site
Salta, Argentina, A4400ERH
Nycomed Investigational Site
San Miguel de Tucuman, Argentina, T4000IFL
Brazil
Nycomed Investigational Site
Florianopolis, Brazil, 88040-970
Nycomed Investigational Site
Goiânia, Brazil, 74110-010
Nycomed Investigational Site
Porto Alegre, Brazil, 91350-200
Nycomed Investigational Site
Porto Alegre, Brazil, 90035-074
Nycomed Investigational Site
Porto Alegre, Brazil, 90610-000
Nycomed Investigational Site
Santo André, São Paulo, Brazil, 09060-650
Nycomed Investigational Site
Sorocaba, Brazil, 18040350
Nycomed Investigational Site
São Paulo, Brazil, 02189-000
Nycomed Investigational Site
São Paulo, Brazil, 04266-010
Nycomed Investigational Site
São Paulo, Brazil, 05403-000
Nycomed Investigational Site
São Paulo, Brazil, 05437-010
Germany
Nycomed Investigational Site
Berlin, Germany, 10969
Nycomed Investigational Site
Bonn, Germany, 53119
Nycomed Investigational Site
Landsberg, Germany, 86899
Nycomed Investigational Site
Rüdersdorf, Germany, 15562
Nycomed Investigational Site
Schwetzingen, Germany, 68723
Israel
Nycomed Investigational Site
Beer-Sheva, Israel, 84101
Nycomed Investigational Site
Haifa, Israel, 34362
Nycomed Investigational Site
Jerusalem, Israel, 91031
Nycomed Investigational Site
Jerusalem, Israel, 91120
Nycomed Investigational Site
Kfar Saba, Israel, 44281
Nycomed Investigational Site
Petach Tikva, Israel, 49100
Nycomed Investigational Site
Rehovot, Israel, 76100
Nycomed Investigational Site
Tel-Aviv, Israel, 64239
Russian Federation
Nycomed Investigational Site
Barnaul, Russian Federation, 656045
Nycomed Investigational Site
Moscow, Russian Federation, 125284
Nycomed Investigational Site
Moscow, Russian Federation, 123182
Nycomed Investigational Site
Moscow, Russian Federation, 105077
Nycomed Investigational Site
Novosibirsk, Russian Federation, 630087
Nycomed Investigational Site
Novosibirsk, Russian Federation, 630051
Nycomed Investigational Site
Novosibirsk, Russian Federation, 630091
Nycomed Investigational Site
St. Petersburg, Russian Federation, 197089
Nycomed Investigational Site
Tomsk, Russian Federation, 634050
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01455194     History of Changes
Other Study ID Numbers: CL-9709-301-RD, 2011-000683-99, U1111-1133-6333
Study First Received: October 17, 2011
Last Updated: September 17, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Russia: Ministry of Health of the Russian Federation

Keywords provided by Takeda:
ciclesonide
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014