Phase 3
Completed N=520
Effect of High Dose Ciclesonide on Asthma Control
Source: ClinicalTrials.gov NCT01455194 ↗Enrolled (actual)
520
Serious AEs
1.8%
Results posted
Oct 2016
Primary outcomePrimary: Asthma Control Questionnaire (ACQ) Score at Baseline — 2.24; 2.15; 2.19 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asthma Control Questionnaire (ACQ) Score at Baseline |
2.24; 2.15; 2.19 | — |
| PRIMARY Change From Baseline in ACQ Score to Tlast |
-0.833; -0.799; -0.955 | 0.2988 |
| SECONDARY Time Course of ACQ |
1.100; 1.000; 1.000 | — |
| SECONDARY Number of Weeks With Well-controlled Asthma Over the Course of the Study |
1211; 1514; 1447 | 0.8465 |
| SECONDARY Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study |
38; 45; 51; 87; 81; 85 | 0.4186 |
| SECONDARY Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement |
73; 84; 81; 112; 107; 115 | 0.6062 |
| SECONDARY Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point |
56; 69; 63; 91; 95; 93 | 0.5397 |
| SECONDARY Number of Participants Reporting Time to First Asthma Exacerbation |
5; 11; 10 | 0.2264 |
| SECONDARY Number of Participants Reporting Asthma Exacerbations Rates |
5; 10; 10 | 0.2880 |
| SECONDARY Number of Participants With Markedly High Benefits |
0; 0; 0 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) |
109; 85; 86; 89 | — |
| SECONDARY Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs |
0; 0; 0 | — |
| SECONDARY Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings |
0; 0; 0 | — |
| SECONDARY Number of Participants With Markedly Abnormal Laboratory Values |
0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01455194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.