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Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.

Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma. - Study to examine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001177
Enrollment
50
Registered
2008-06-06
Start date
2008-06-01
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

Add tulobuterol transdermal therapeutic system(TTS) 2 mg once daily to the current medication Add inhaled salmeterol 50 mcg twice daily to the current medication

Sponsors

Kyoto University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Mild or moderate asthma 2. Poorly controlled patients who need additional controler medication to the current treatment including inhaled corticosteroid 3. Astmatic patients diagnosed definitely by airway responsiveness test or airway reversibility test 4. Never smokers or ex-smokers of < 10 pack-years who quit smoking for > one year

Exclusion criteria

Exclusion criteria: 1. Patients with concomitant respiratory disease that may interfere with evaluation of outcomes 2. Patients with hypersensitivity to salmeterol or tulobuterol 3. Patients with dermal disease potentially intolerant to transdermal medication 4. Patients with hyperthyroidism or cardiovascular disease which preclude a use of beta-agonist 5. Pregnancy or lactation 6. Patients who are considered inappropriate by physicians in charge

Design outcomes

Primary

MeasureTime frame
Parameters of impulse oscillometry

Secondary

MeasureTime frame
1. Indices of pulmonary function 2. Exhaled nitric oxide concentrations 3. degree of dyspnea (using Medical Research Council dyspnea scale) 4. Quality of life (using St. George's Respiratory Questionnaire) 5. ACT(asthma control test) 6. clinical symptoms(such as wheezing)

Countries

Japan

Contacts

Public ContactHideki Inoue

Kyoto University Graduate School of Medicine Department of Respiratory Medicine

075-751-3830

Outcome results

None listed

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