Safety and Efficacy of Ciclesonide in Patients with Asthma

18 Mar, 14

Ciclesonide PMDI is Safe and Effective in Indian Asthmatics

Objective

To determine the efficacy and safety of 200 mcg Ciclesonide (Ciclohale; 160 mcg ex-actuator; Cipla Ltd., India) delivered via HFA pressurized metered dose inhaler (pMDI) in mild to moderate persistent asthma patients.

Patients and Methods

Open-label, non-comparative, multicenter study.
100 patients aged 18 years and above were included and given treatment with 160 mcg Ciclesonide (2 puffs of 80 mcg via HFA pMDI) once daily for 6 weeks.
Primary efficacy variable was change from baseline in FEV₁ and secondary efficacy variables were change from baseline in morning PEFR, total symptom scores and use of rescue medication.
The total symptom scores were the sum of daytime and nighttime symptoms. Night-time symptom scores were graded on a 5-point scale and daytime symptoms like breathlessness, cough and wheeze were graded on a 6-point scale as follows:

Other assessments included urinary cortisol levels, biochemical, hematological and ECG at week 6 from baseline.

Results

1. Efficacy

There was a significant improvement in FEV₁ at the end of 6 weeks.

PEFR showed significant improvement after 3 weeks of treatment.

There was a significant improvement in the nighttime and daytime symptom scores after 1 week of treatment with inhaled Ciclesonide (p<0.001 compared to baseline).
There was a significant reduction in the use of rescue medication namely Salbutamol after 1 week of treatment with inhaled Ciclesonide (p<0.001 compared to baseline).

2. Safety

There was no change in the blood pressure, pulse and respiratory rate, hematological and biochemical parameters throughout the study period.
Only few patients reported adverse events and most commonly seen were cough, breathlessness, headache, itching in throat/pharyngitis and hoarseness of voice.
There were no significant differences in the urinary cortisol levels corrected for creatinine (mcg/mg) from baseline to 6 weeks.

Conclusion

Ciclesonide 160 mcg HFA pMDI is efficacious and safe for the treatment of mild to moderate asthma.

1242, presented at European Respiratory Society (ERS) Conference, 2006

Related Topics

night-time symptoms

pressurized metered dose inhaler