Study to examine the effects of Salmeterol/fluticasone propionate combination(SFC) in patients with cough variant asthma(CVA)

UMIN ID: UMIN000002390

Registered date:26/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Cough variant asthma
• Date of first enrollment: 2009/11/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Inhale Salmeterol/fluticasone propionate combination 250 mcg twice daily
Inhale Fluticasone propionate 200 mcg twice daily, and take Montelukast 10 mg once daily

Outcome(s)

• Primary Outcome: Visual analogue scale score of cough
• Secondary Outcome: 1)Parameters of impulse oscillometry 2)Indices of pulmonary function 3)Indices of Capsicine cough sensitivity 4)Exhaled nitric oxide concentrations 5)Biomarker levels of induced sputum 6)Biomarker levels of serum and urine 7)Scores of questionnaires

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Patients without cough symptom in the last 1 week before enrollment 2)Patients with other respiratory diseases 3)Patients taking Long acting be-ta 2 agonist(LABA) or Leukotriene receptor antagonist(LTRA) 4)Patients who are given systemic corticosteroid in the last 4 weeks 5)Patients who suffered from upper respiratory infection in the last 4 weeks 6)Patients who had smoked in the last 6 months, or who had smoked more than 10 pack year in the past 7)Patients who are considered inappropriate by physicians in charge

Related Information

• Primary Sponsor: Kyoto University Graduate School of Medicine
• Secondary Sponsor: None
• Source(s) of Monetary Support: Kyoto University Graduate School of Medicine,None