Effect of High Dose Ciclesonide on Asthma Control (CONTRAST)
This study is currently recruiting participants.
Verified August 2012 by Takeda
Sponsor:
Nycomed: A Takeda Company
Information provided by (Responsible Party):
Takeda ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier:
NCT01455194
First received: October 17, 2011
Last updated: August 19, 2012
Last verified: August 2012
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455194
Contacts
| Contact: Takeda Study Registration Call Center | +1-800-778-2860 | medicalinformation@tpna.com |
Locations
| Argentina | |
| Nycomed Investigational Site | Not yet recruiting |
| Capital Federal, Buenos Aires, Argentina, C1425BEN | |
| Nycomed Investigational Site | Not yet recruiting |
| Ciudad Autonoma de Buenos Aires, Argentina, C1426ABP | |
| Nycomed Investigational Site | Not yet recruiting |
| Ciudad Autonoma de Buenos Aires, Argentina, C1015ABO | |
| Nycomed Investigational Site | Not yet recruiting |
| Rosario, Argentina, 2000 | |
| Nycomed Investigational Site | Not yet recruiting |
| Rosario-Santa Fe, Argentina, S2000KZD | |
| Nycomed Investigational Site | Not yet recruiting |
| Salta, Argentina, A4400ERH | |
| Nycomed Investigational Site | Not yet recruiting |
| San Miguel de Tucuman, Argentina, T4000IFL | |
| Brazil | |
| Nycomed Investigational Site | Not yet recruiting |
| Florianopolis, Brazil, 88040-970 | |
| Nycomed Investigational Site | Not yet recruiting |
| Goiânia, Brazil, 74110-010 | |
| Nycomed Investigational Site | Not yet recruiting |
| Porto Alegre, Brazil, 91350-200 | |
| Nycomed Investigational Site | Not yet recruiting |
| Porto Alegre, Brazil, 90035-074 | |
| Nycomed Investigational Site | Not yet recruiting |
| Porto Alegre, Brazil, 90610-000 | |
| Nycomed Investigational Site | Not yet recruiting |
| Santo André, São Paulo, Brazil, 09060-650 | |
| Nycomed Investigational Site | Not yet recruiting |
| Sorocaba, Brazil, 18040350 | |
| Nycomed Investigational Site | Not yet recruiting |
| São Paulo, Brazil, 02189-000 | |
| Nycomed Investigational Site | Not yet recruiting |
| São Paulo, Brazil, 04266-010 | |
| Nycomed Investigational Site | Not yet recruiting |
| São Paulo, Brazil, 05403-000 | |
| Nycomed Investigational Site | Not yet recruiting |
| São Paulo, Brazil, 05437-010 | |
| Germany | |
| Nycomed Investigational Site | Recruiting |
| Berlin, Germany, 10969 | |
| Nycomed Investigational Site | Recruiting |
| Bonn, Germany, 53119 | |
| Nycomed Investigational Site | Recruiting |
| Landsberg, Germany, 86899 | |
| Nycomed Investigational Site | Recruiting |
| Rüdersdorf, Germany, 15562 | |
| Nycomed Investigational Site | Recruiting |
| Schwetzingen, Germany, 68723 | |
| Israel | |
| Nycomed Investigational Site | Not yet recruiting |
| Beer-Sheva, Israel, 84101 | |
| Nycomed Investigational Site | Not yet recruiting |
| Haifa, Israel, 34362 | |
| Nycomed Investigational Site | Not yet recruiting |
| Jerusalem, Israel, 91031 | |
| Nycomed Investigational Site | Not yet recruiting |
| Jerusalem, Israel, 91120 | |
| Nycomed Investigational Site | Not yet recruiting |
| Kfar Saba, Israel, 44281 | |
| Nycomed Investigational Site | Not yet recruiting |
| Petach Tikva, Israel, 49100 | |
| Nycomed Investigational Site | Not yet recruiting |
| Rehovot, Israel, 76100 | |
| Nycomed Investigational Site | Not yet recruiting |
| Tel-Aviv, Israel, 64239 | |
| Russian Federation | |
| Nycomed Investigational Site | Not yet recruiting |
| Barnaul, Russian Federation, 656045 | |
| Nycomed Investigational Site | Not yet recruiting |
| Moscow, Russian Federation, 125284 | |
| Nycomed Investigational Site | Not yet recruiting |
| Moscow, Russian Federation, 123182 | |
| Nycomed Investigational Site | Not yet recruiting |
| Moscow, Russian Federation, 105077 | |
| Nycomed Investigational Site | Not yet recruiting |
| Novosibirsk, Russian Federation, 630087 | |
| Nycomed Investigational Site | Not yet recruiting |
| Novosibirsk, Russian Federation, 630051 | |
| Nycomed Investigational Site | Not yet recruiting |
| Novosibirsk, Russian Federation, 630091 | |
| Nycomed Investigational Site | Not yet recruiting |
| St. Petersburg, Russian Federation, 197089 | |
| Nycomed Investigational Site | Not yet recruiting |
| Tomsk, Russian Federation, 634050 | |
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
| Study Director: | Medical Director | Nycomed: A Takeda Company |
More Information
No publications provided
| Responsible Party: | Takeda ( Nycomed: A Takeda Company ) |
| 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: | August 19, 2012 |
| 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 Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013