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Comparison of the effect of SFC (Salmeterol Fluticasone Combination) and ICS plus Tulobuterol Patch in asthma : multicenter open-labelled double cross over study

Comparison of the effect of SFC (Salmeterol Fluticasone Combination) and ICS plus Tulobuterol Patch in asthma : multicenter open-labelled double cross over study - Comparison of the effect of SFC (Salmeterol Fluticasone Combination) and ICS plus Tulobuterol Patch in asthma : double cross over study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002719
Enrollment
50
Registered
2009-11-06
Start date
2009-11-01
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

Asthma

Interventions

The first 4week are treated with SFC. The second 4week are treated with ICS plus Tulobuterol Patch. The third 4week are treated with SFC. The first 4week are treated with ICS plus Tulobuterol Patc

Sponsors

Kansai Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with asthma and who meet following requirements 1) patient receiving SFC or ICS+ TP (without regard to other drugs) 2) patient can write down the patient-dairy of this study appropriately from the doctor's viewpoint 3) patient can understand how to use PEF-meter and use appropriately from the doctor's viewpoint 4) patient can keep the rule of this study and doctor's direction from the doctor's viewpoint 5) obtain informed consent before registration to this study 6) Patient aged 20 years and above when doctors obtain informed consent

Exclusion criteria

Exclusion criteria: 1) severe asthma like following examples patients with a past history of asthma attack with airway cannulation or respiratory arrest , CO2 excess symptom, hypoxic convulsion , syncope patients receiving steroid injection or ACTH injection during 4 weeks before registration to this study patients receiving oral steroid or beta2 agonist injection , xanthene injection during 4 weeks before registration to this study 2) patient suspected of infection which has no effective antibacterial drug or deep mycosis 3) uncontrolled diabetes mellitus , hypertension , cardiac disease or hyperthyroidism 4) tuberculosis or respiratory infection 5) patient experienced adverse effect by components of study drug or another inhaled powder medicine 6) patients who is pregnant or suspected of pregnancy , wish to get pregnant , nursing mom 7) patients who don't have ability to agree 8) inappropriate patient for this study from the doctor's viewpoint

Design outcomes

Primary

MeasureTime frame
Mean variation of morning PEF

Secondary

MeasureTime frame
Pulmonary function (FEV1, V 50,V25) Asthma Control Test Patient questionnaire Mean variation of evening PEF

Countries

Japan

Outcome results

None listed

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