Clinical trial NCT01455194: Effect of High Dose Ciclesonide on Asthma Control
Official title: Control of Moderate or Severe Asthma With 160, 320 and 640 mcg Ciclesonide/Day. A One-year Randomised, Double-blind, Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchial Asthma
Keywords: ciclesonide
asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 520
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Asthma Control Questionnaire (ACQ) Score at Baseline
timeFrame: Baseline
measure: Change From Baseline in ACQ Score to Tlast
timeFrame: Week 52
Secondary outcomes:
measure: Time Course of ACQ
timeFrame: Baseline, Week 52 (Treatment period)
measure: Number of Weeks With Well-controlled Asthma Over the Course of the Study
timeFrame: Baseline up to Week 52 (treatment period)
measure: Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study
timeFrame: Week 52
measure: Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement
timeFrame: Baseline up to Week 52 (treatment period)
measure: Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point
timeFrame: Baseline up to Week 52 (treatment period)
measure: Number of Participants Reporting Time to First Asthma Exacerbation
timeFrame: Baseline up to Week 52 (treatment period)
measure: Number of Participants Reporting Asthma Exacerbations Rates
timeFrame: Baseline up to Week 52 (treatment period)
measure: Number of Participants With Markedly High Benefits
timeFrame: Week 1 up to Week 52
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
timeFrame: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
measure: Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
measure: Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings
timeFrame: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
measure: Number of Participants With Markedly Abnormal Laboratory Values
timeFrame: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
Other outcomes:
Locations:
city: Capital Federal, Buenos Aires
country: Argentina
city: Ciudad Autonoma de Buenos Aires
country: Argentina
city: Rosario-Santa Fe
country: Argentina
city: Rosario
country: Argentina
city: Salta
country: Argentina
city: Tucuman
country: Argentina
city: Florianopolis
country: Brazil
city: Goiania
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio de Janiero
country: Brazil
city: Santo Andre, Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Landsberg
country: Germany
city: Rudersdorf
country: Germany
city: Schwetzingen
country: Germany
city: Beer-Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Barnaul
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: