CompletedNCT01455194CONTRASTUpdated Feb 10, 2017Results posted

Effect of High Dose Ciclesonide on Asthma Control

A Phase 3 interventional study of Ciclesonide in Bronchial Asthma, sponsored by AstraZeneca. Completed at 30 sites in 5 countries. Open to participants aged 12 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-10.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 520
Allocation: Randomized
Ages: 12 Years to 70 Years
Sex: All

Study 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).

Conditions studied

Bronchial Asthma

Browse trials for

Asthma 3,920

Keywords

ciclesonide
asthma

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 520 is above the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 520 participants (actual)

Study arms

Active comparator
CIC 160
Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg)
Drug: Ciclesonide
Active comparator
CIC 320
Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg)
Drug: Ciclesonide
Active comparator
CIC 640
Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg)
Drug: Ciclesonide

Interventions

DrugCiclesonide
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)

What researchers measure

Primary outcomes

Asthma Control Questionnaire (ACQ) Score at Baseline
The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Time frame: Baseline
Change From Baseline in ACQ Score to Tlast
The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Time frame: Week 52

Secondary outcomes

Time Course of ACQ
The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Time frame: Baseline, Week 52 (Treatment period)
Number of Weeks With Well-controlled Asthma Over the Course of the Study
The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Time frame: Baseline up to Week 52 (treatment period)
Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study
Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Time frame: Week 52
Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement
Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Time frame: Baseline up to Week 52 (treatment period)
Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point
Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.
Time frame: Baseline up to Week 52 (treatment period)
Number of Participants Reporting Time to First Asthma Exacerbation
Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication
Time frame: Baseline up to Week 52 (treatment period)
Number of Participants Reporting Asthma Exacerbations Rates
Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.
Time frame: Baseline up to Week 52 (treatment period)
Number of Participants With Markedly High Benefits
The analyses was intended to identify participant's subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included.
Time frame: Week 1 up to Week 52
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.
Time frame: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs
Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP \>170 millimeters of mercury (mm Hg) or \<85 mm Hg, Diastolic BP \>105 mm Hg, resting pulse rate: \>120 bpm or \<50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment \>40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment \>30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.
Time frame: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings
Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.
Time frame: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
Number of Participants With Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.
Time frame: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)

Results

Posted Oct 25, 2016

Participant flow

Participants took part in the study at 5 investigative sites in Argentina, Brazil, Germany, Israel and Russia from 10 November 2011 to 15 August 2014.

Participant flow — Overall Study
Milestone	Baseline Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Started	153	120	122	125
Completed	0	89	92	97
Not completed	153	31	30	28
Withdrew: Screen failure	20	0	0	0
Withdrew: Randomisation failure	90	0	0	0
Withdrew: Deterioration in asthma	12	6	14	9
Withdrew: Adverse event	1	1	1	3
Withdrew: Withdrawal by subject	21	16	12	9
Withdrew: Lost to follow-up	2	0	1	1
Withdrew: Pregnancy	0	1	1	0
Withdrew: Discontinuation criterion fulfilled	3	2	0	2
Withdrew: Miscellaneous	4	5	1	4

Outcome measures

PrimaryAsthma Control Questionnaire (ACQ) Score at Baseline

The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.

Time frame:: Baseline
Reported as:: Mean · units on a scale

Asthma Control Questionnaire (ACQ) Score at Baseline
units on a scale	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Asthma Control Questionnaire (ACQ) Score at Baseline	2.24 ± 0.031	2.15 ± 0.035	2.19 ± 0.032

PrimaryChange From Baseline in ACQ Score to Tlast

Time frame:: Week 52
Reported as:: Mean · units on a scale

Change From Baseline in ACQ Score to Tlast
units on a scale	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Change From Baseline in ACQ Score to Tlast	-0.833 ± 0.1028	-0.799 ± 0.1019	-0.955 ± 0.0969

Statistical analysis

Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · ANCOVA · p = 0.2988 · Ls mean difference: -0.122 · 95% CI -0.353 to 0.109
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · ANCOVA · p = 0.7741 · Ls mean difference: 0.034 · 95% CI -0.198 to 0.266
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · ANCOVA · p = 0.1835 · Ls mean difference: -0.156 · 95% CI -0.387 to 0.074

SecondaryTime Course of ACQ

The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.

Time frame:: Baseline, Week 52 (Treatment period)
Reported as:: Median · Weeks

Time Course of ACQ
Weeks	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Time Course of ACQ	1.100 (0.00 to 4.40)	1.000 (0.00 to 3.90)	1.000 (0.00 to 4.60)

SecondaryNumber of Weeks With Well-controlled Asthma Over the Course of the Study

The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.

Time frame:: Baseline up to Week 52 (treatment period)
Reported as:: Number · weeks

Number of Weeks With Well-controlled Asthma Over the Course of the Study
weeks	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Number of Weeks With Well-controlled Asthma Over the Course of the Study	1211	1514	1447

Statistical analysis

Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Wilcoxon (Mann-Whitney) · p = 0.8465 · Hodges-lehmann point estimate: 0.000 · 95% CI -3.000 to 4.000Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Wilcoxon (Mann-Whitney) · p = 0.4175 · Hodges-lehmann point estimate: 1.000 · 95% CI -2.000 to 5.000Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.

SecondaryNumber of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study

Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.

Time frame:: Week 52
Reported as:: Number · participants

Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Well-controlled Asthma	38	45	51
ACQ Improvement	87	81	85

Statistical analysis

Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Fisher Exact · p = 0.4186
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Fisher Exact · p = 0.1460
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Fisher Exact · p = 0.6017
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Fisher Exact · p = 0.3305
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Fisher Exact · p = 0.4860
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Fisher Exact · p = 0.8922

SecondaryNumber of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement

Time frame:: Baseline up to Week 52 (treatment period)
Reported as:: Number · participants

Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Well-controlled Asthma	73	84	81
ACQ Improvement	112	107	115

Statistical analysis

Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.6062 · Hazard ratio (hr): 1.042 · 95% CI 0.890 to 1.221A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.4674 · Hazard ratio (hr): 1.050 · 95% CI 0.921 to 1.197A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Log Rank · p = 0.2523 · Hazard ratio (hr): 1.201 · 95% CI 0.878 to 1.642A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Log Rank · p = 0.5026 · Hazard ratio (hr): 0.913 · 95% CI 0.700 to 1.191A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.4893 · Hazard ratio (hr): 0.898 · 95% CI 0.661 to 1.219A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.2193 · Hazard ratio (hr): 1.181 · 95% CI 0.906 to 1.538A hazard ratio of \>1 represented a benefit for the test treatment.

SecondaryNumber of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point

Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>= 1.5 indicates uncontrolled asthma.

Time frame:: Baseline up to Week 52 (treatment period)
Reported as:: Number · participants

Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
ACQ cut-off at 0.5	56	69	63
ACQ cut-off at 1.0	91	95	93
ACQ cut-off at 1.25	99	101	101
ACQ cut-off at 1.5	103	105	107

Statistical analysis

Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.5397 · Hazard ratio (hr): 1.058 · 95% CI 0.884 to 1.266A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.9458 · Hazard ratio (hr): 1.005 · 95% CI 0.870 to 1.161A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.7213 · Hazard ratio (hr): 1.026 · 95% CI 0.893 to 1.178A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.4807 · Hazard ratio (hr): 1.050 · 95% CI 0.917 to 1.202A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Log Rank · p = 0.1150 · Hazard ratio (hr): 1.326 · 95% CI 0.934 to 1.884A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Log Rank · p = 0.6281 · Hazard ratio (hr): 1.074 · 95% CI 0.805 to 1.431A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Log Rank · p = 0.6853 · Hazard ratio (hr): 1.059 · 95% CI 0.803 to 1.397A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Log Rank · p = 0.6995 · Hazard ratio (hr): 1.055 · 95% CI 0.804 to 1.385A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.3080 · Hazard ratio (hr): 0.837 · 95% CI 0.595 to 1.178A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.6645 · Hazard ratio (hr): 0.939 · 95% CI 0.705 to 1.250A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.9564 · Hazard ratio (hr): 0.992 · 95% CI 0.753 to 1.308A hazard ratio of \>1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.7367 · Hazard ratio (hr): 1.047 · 95% CI 0.800 to 1.371A hazard ratio of \>1 represented a benefit for the test treatment.

SecondaryNumber of Participants Reporting Time to First Asthma Exacerbation

Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication

Time frame:: Baseline up to Week 52 (treatment period)
Reported as:: Number · participants

Number of Participants Reporting Time to First Asthma Exacerbation
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Number of Participants Reporting Time to First Asthma Exacerbation	5	11	10

Statistical analysis

Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.2264 · Hazard ratio (hr): 1.367 · 95% CI 0.824 to 2.267A hazard ratio of \<1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Log Rank · p = 0.1373 · Hazard ratio (hr): 2.102 · 95% CI 0.789 to 5.602A hazard ratio of \<1 represented a benefit for the test treatment.
Treatment Period: Ciclesonide 320 mcg vs Treatment Period: Ciclesonide 640 mcg · Log Rank · p = 0.7732 · Hazard ratio (hr): 0.882 · 95% CI 0.375 to 2.074A hazard ratio of \<1 represented a benefit for the test treatment.

SecondaryNumber of Participants Reporting Asthma Exacerbations Rates

Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.

Time frame:: Baseline up to Week 52 (treatment period)
Reported as:: Number · participants

Number of Participants Reporting Asthma Exacerbations Rates
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Number of Participants Reporting Asthma Exacerbations Rates	5	10	10

Statistical analysis

Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 640 mcg · Fisher Exact · p = 0.2880
Treatment Period: Ciclesonide 160 mcg vs Treatment Period: Ciclesonide 320 mcg · Fisher Exact · p = 0.2864

SecondaryNumber of Participants With Markedly High Benefits

The analyses was intended to identify participant's subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =\<0.75 indicate well-controlled asthma, scores between 0.76 and \< 1.5 indicate partly controlled asthma, and a score \>=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included.

Time frame:: Week 1 up to Week 52
Reported as:: Number · participants

Number of Participants With Markedly High Benefits
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Number of Participants With Markedly High Benefits	0	0	0

SecondaryNumber of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.

Time frame:: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
Reported as:: Number · participants

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
participants	Baseline Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)	109	85	86	89

SecondaryNumber of Participants Reporting Clinically Significant Change From Baseline in Vital Signs

Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP \>170 millimeters of mercury (mm Hg) or \<85 mm Hg, Diastolic BP \>105 mm Hg, resting pulse rate: \>120 bpm or \<50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment \>40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment \>30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.

Time frame:: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
Reported as:: Number · participants

Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs	0	0	0

SecondaryNumber of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings

Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.

Time frame:: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
Reported as:: Number · participants

Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings	0	0	0

SecondaryNumber of Participants With Markedly Abnormal Laboratory Values

The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.

Time frame:: Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)
Reported as:: Number · participants

Number of Participants With Markedly Abnormal Laboratory Values
participants	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
Number of Participants With Markedly Abnormal Laboratory Values	0	0	0

Adverse events

Collected over Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Baseline Period: Ciclesonide 160 mcg	—	1/520 (0.2%)	64/520 (12.3%)
Treatment Period: Ciclesonide 160 mcg	—	6/119 (5%)	65/119 (54.6%)
Treatment Period: Ciclesonide 320 mcg	—	9/122 (7.4%)	65/122 (53.3%)
Treatment Period: Ciclesonide 640 mcg	—	0/126 (0%)	70/126 (55.6%)

Most frequent serious events

Showing 10 of 17

Most frequent serious events
Event	Baseline Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
PneumoniaInfections and infestations	1/520	0/119	2/122	0/126
Myocardial infarctionCardiac disorders	0/520	1/119	1/122	0/126
AppendicitisInfections and infestations	0/520	1/119	1/122	0/126
Invertebral disc protrusionMusculoskeletal and connective tissue disorders	0/520	1/119	0/122	0/126
Autonomic nervous system imbalanceNervous system disorders	0/520	1/119	0/122	0/126
Cerebellar ischaemiaNervous system disorders	0/520	1/119	0/122	0/126
Respiratory failureRespiratory, thoracic and mediastinal disorders	0/520	1/119	0/122	0/126
Hypertensive crisisVascular disorders	0/520	1/119	0/122	0/126
Atrial fibrillationCardiac disorders	0/520	0/119	1/122	0/126
TachycardiaCardiac disorders	0/520	0/119	1/122	0/126

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Baseline Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg
NasopharyngitisInfections and infestations	6/520	23/119	25/122	22/126
HeadacheNervous system disorders	43/520	22/119	23/122	16/126
BronchitisInfections and infestations	1/520	18/119	16/122	16/126
InfluenzaInfections and infestations	0/520	6/119	6/122	11/126
Rhinitis allergicRespiratory, thoracic and mediastinal disorders	3/520	8/119	3/122	6/126
PharyngitisInfections and infestations	1/520	4/119	8/122	4/126
RhinitisInfections and infestations	6/520	2/119	8/122	4/126
SinusitisInfections and infestations	1/520	7/119	5/122	8/126
Back painMusculoskeletal and connective tissue disorders	3/520	4/119	2/122	8/126
Upper respiratory tract infectionInfections and infestations	3/520	7/119	1/122	6/126

Baseline characteristics

The full analysis set (FAS) was defined as all randomized participants who took at least 1 dose of double-blind study medication.Baseline data was summarized only for those participants who entered treatment period which was the core period of the trial.

Age, Continuous
Age, Continuous(years)	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg	Total
Mean	43.2 ± 14.86	44.7 ± 15.60	45.3 ± 16.22	44.4 ± 15.57

Gender
Gender(Participants)	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg	Total
Female	72	77	81	230
Male	48	45	44	137

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg	Total
Black or African American	6	5	4	15
White	113	115	114	342
Unknown or Not Reported	1	2	7	10

Height
Height(meter (m))	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg	Total
Mean	1.65 ± 0.093	1.66 ± 0.101	1.65 ± 0.104	1.65 ± 0.099

Weight
Weight(kilograms (kg))	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg	Total
Mean	74.59 ± 16.371	77.98 ± 18.993	73.72 ± 14.660	75.42 ± 16.811

Body Mass Index
Body Mass Index(kilogram per meter square (kg/m^2))	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg	Total
Mean	27.34 ± 5.217	28.42 ± 6.346	27.12 ± 5.373	27.62 ± 5.681

History of exacerbations
History of exacerbations(participants)	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg	Total
0	70	70	63	203
1	17	19	21	57
2-3	4	3	4	11
4+	0	0	0	0
Unknown	29	30	37	96

Smoking Status
Smoking Status(participants)	Treatment Period: Ciclesonide 160 mcg	Treatment Period: Ciclesonide 320 mcg	Treatment Period: Ciclesonide 640 mcg	Total
Never	109	102	109	320
Current	1	1	1	3
Former	10	19	15	44

7 further baseline measures are reported on the registry.

Study locations

30 sites

Capital Federal, Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aires, Argentina
Rosario-Santa Fe, Argentina
Rosario, Argentina
Salta, Argentina
Tucuman, Argentina
Florianopolis, Brazil
Goiania, Brazil
Porto Alegre, Brazil
Rio de Janiero, Brazil
Santo Andre, Sao Paulo, Brazil
Sao Paulo, Brazil
Sorocaba, Brazil
Berlin, Germany
Bonn, Germany
Landsberg, Germany
Rudersdorf, Germany
Schwetzingen, Germany
Beer-Sheva, Israel
Haifa, Israel
Jerusalem, Israel
Kfar Saba, Israel
Petach Tikva, Israel
Rehovot, Israel
Tel Aviv, Israel
Barnaul, Russian Federation
Moscow, Russian Federation
Novosibirsk, Russian Federation
St. Petersburg, Russian Federation
Tomsk, Russian Federation

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01455194
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Oct 19, 2011
Start date: Nov 2011
Primary completion: Aug 2014
Completion: Aug 2014
Results posted: Oct 25, 2016
Last update: Feb 10, 2017

Study contacts

AstraZeneca AstraZeneca

study director · AstraZeneca

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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