Efficacy and safety of once-daily inhaled ciclesonide in adults with mild to moderate asthma: A double-blind, placebo-controlled study†

  1. Mitsuru ADACHI1,*,
  2. Kyosuke ISHIHARA2,
  3. Hiroshi INOUE3,
  4. Koichiro KUDO4,
  5. Kiyoshi TAKAHASHI5,
  6. Yutaka MORITA6,
  7. Ken-Ichi MASUDA7,
  8. Yoshinori TAKADA7,
  9. Ryuichi KATO8,
  10. Terumasa MIYAMOTO9

Article first published online: 20 JUN 2007

DOI: 10.1111/j.1440-1843.2007.01111.x

Issue

Respirology

Respirology

Volume 12, Issue 4, pages 566–572, July 2007

Additional Information

How to Cite

ADACHI, M., ISHIHARA, K., INOUE, H., KUDO, K., TAKAHASHI, K., MORITA, Y., MASUDA, K.-I., TAKADA, Y., KATO, R. and MIYAMOTO, T. (2007), Efficacy and safety of once-daily inhaled ciclesonide in adults with mild to moderate asthma: A double-blind, placebo-controlled study. Respirology, 12: 566–572. doi: 10.1111/j.1440-1843.2007.01111.x

Author Information

  1. 1

    Showa University, School of Medicine, Tokyo,

  2. 2

    Kobe City Medical Center General Hospital, Kobe,

  3. 3

    Iwate Medical University, Morioka,

  4. 4

    International Medical Center of Japan, Tokyo,

  5. 5

    National Hospital Organization Minami-Okayama Medical Center, Okayama,

  6. 6

    Ochanomizu University, Graduate School of Humanities and Sciences, Tokyo,

  7. 7

    Teijin Pharma Limited, Tokyo,

  8. 8

    Keio University, School of Medicine, Tokyo and

  9. 9

    Japan Clinical Allergy Research Institute, Tokyo, Japan

*Mitsuru Adachi, First Department of Internal Medicine, School of Medicine, Showa University, 1-5-8, Hatanodai Shinagawa-ku, Tokyo 142-8666, Japan. Email: adachim@med.showa-u.ac.jp

  • †

    Conflict of interest statement: This study was funded by Teijin Pharma. Teijin Pharma was involved, with the cooperation of the authors, in the design, data analysis and redaction of the paper.

Publication History

  1. Issue published online: 20 JUN 2007
  2. Article first published online: 20 JUN 2007
  3. Received 25 August 2006; invited to revise 19 September 2006; revised 12 October 2006; accepted 29 October 2006 (Associate Editor: Takahide Nagase).

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Keywords:

  • ciclesonide;
  • inhaled corticosteroid;
  • mild to moderate asthma;
  • once-daily;
  • on-site-activation

Background and objective:  Inhaled corticosteroids are recommended as first-line therapy for the management of asthma, although side-effects may limit their use. Ciclesonide, a novel pro-drug inhaled corticosteroid, exerts potent and prolonged local anti-inflammatory effects in the lungs, and is considered to have an improved safety and tolerability profile. The aim of this study was to evaluate the efficacy and safety of ciclesonide in adult patients with mild to moderate asthma.

Methods:  A placebo-controlled, multicentre, randomized, double-blind, parallel-group study was conducted. During the 4-week baseline period, patients were given 400 μg/day of beclomethasone dipropionate in a chlorofluorocarbon formulation. After the baseline period, 311 patients were given once-daily 100, 200 or 400 μg of ciclesonide or placebo for an 8-week treatment period without the use of a spacer. The primary efficacy variable was morning PEF.

Results:  Changes in the morning PEF (least squares mean) at the end of the study were 4.23 L/min (P < 0.001) in the 100 μg group, 3.75 L/min (P < 0.001) in the 200 μg group, −0.40 L/min (P < 0.001) in the 400 μg group, as compared with −24.95 L/min in the placebo group. In the ciclesonide groups, the PEF remained at the same level as the baseline period. No large differences were observed between the placebo group and the ciclesonide groups regarding safety.

Conclusion:  Once-daily administration of ciclesonide at doses of 100, 200 or 400 μg was shown to be effective in adult patients with mild to moderate asthma. Ciclesonide is considered to have favourable safety profiles and be well tolerated.

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