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Efficacy and safety of a four-week treatment with budesonide/formoterol in patients with cough variant asthma: Open-label, randomized and parallel-group study compared with budesonide.

Efficacy and safety of a four-week treatment with budesonide/formoterol in patients with cough variant asthma: Open-label, randomized and parallel-group study compared with budesonide. - Controlled study to compare the effect of budesonide/formoterol and budesonide in cough variant asthma.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004383
Enrollment
80
Registered
2010-10-14
Start date
2011-02-01
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

Cough variant asthma

Interventions

budesonide/formoterol combination 160/4.5 mcg, two inhalation, twice a day budesonide 200 mcg, two inhalation, twice a day

Sponsors

Kyoto University Graduate School of Medicine
Lead Sponsor
1. Kitano Hospital 2. Osaka Saiseikai Nakatsu Hospital 3. Kobe City Medical Center General Hospital 4. Shinko Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Cough variant asthma patients 2. Patients who have cough symptom 3. Patients who gave consent to the study

Exclusion criteria

Exclusion criteria: 1. Patients with hypersensitivity to Budesonide/formoterol. 2. Patients with other respiratory diseases. 3. Patients who take inhaled corticosteroids in the last 4 weeks 4. Patients who take long acting beta agonists in the last 5 days 5. Patients who take antiallergy agents and inhaled anticholinergic in the last 2 weeks 6. Patients who are given systemic corticosteroids in the last 30 days 7. Current smoker or ex-smoker of > 10 pack-years 8. Pregnancy or lactation 9. Patients who are considered inappropriate by physicians in charge

Design outcomes

Primary

MeasureTime frame
Leicester Cough Questionnaire (LCQ) score—

Secondary

MeasureTime frame
1. Exhaled nitric oxide concentrations 2. Indices of pulmonary function 3. Biomarkers of blood 4. Visual analogue scale score of cough 5. clinical symptoms—

Countries

Japan

Contacts

Public ContactToshiyuki Iwata

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