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Efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus: multicenter study

Efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus: multicenter study - Efficacy and safety of step-down therapy with ciclesonide once-daily and beta2-agonist tulobuterol patch in asthma patients receiving salmeterol/fluticasone propionate diskus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003023
Enrollment
150
Registered
2010-01-13
Start date
2010-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma

Interventions

Patients whose asthma was controlled with salmeterol/fluticasone(low or moderate dose) for at least 3 months,are switched to step-down treatment with ciclesonide and tulobuterol patch. If the asthma i

Sponsors

Hiroshima Allergy Research Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In patients with bronchial asthma (or cough variant asthma), all of the following criteria was required for enrollment : 1) age;20 years or more 2) receiving low or medium dose salmeterol/fluticasone propionate diskus for at least 3 months, and ACT total score =20 or >20 at baseline 3) no use of oral corticosteroids or systemic rescue medication within previous 3 months 4) little or nothing of asthma symptoms within previous 3 months 5) use of 2 times or less per 2 weeks of short-acting beta2-agonist within previous 1 month 6) Written informed consent from the patients

Exclusion criteria

Exclusion criteria: 1)addition or dose-change of antiasthma medications (except for salmeterol/fluticasone propionate diskus) within previous 3 months 2)use of ciclesonide and beta2-agonist tulobuterol patch within previous 3 months 3)corresponding to contraindication on accompanied note of study medication 4)difficult to answer of self administered questionnaire 5)physician decided the patient is unsuitable to enrollment

Design outcomes

Primary

MeasureTime frame
percentage of patients with reducing treatment and maintaining control of asthma

Secondary

MeasureTime frame
1)pulmonary function using spirometry 2)questionnaire of asthma control 3)questionnaire of adverse effects 4)impulse oscillation system parameters and exhaled nitric oxide (only 2 ceters) 5)adverse events

Countries

Japan

Contacts

Public ContactShintaro Miyamoto

Hiroshima University Hospital Department of respiratory medicine

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026