NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Bronchial asthma
Date of first enrollment	12/09/2005
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : APTA-2217 (roflumilast) INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Efficacy (pulmonary function test), safety and pharmacokinetics
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 69age old
Gender	Both
Include criteria	[Inclusion criteria] Patient with bronchial asthma who are 20 to 70 years old, non-smoker or ex-smoker for 12 months or more, 60 to 80 % of predicted FEV1 [Exclusion criteria] Patients with poorly controlled asthma, patients with a clear diagnosis of seasonal asthma and patients who have concurrent respiratory diseases such as COPD, chronic bronchitis, pulmonary emphysema, and bronchiectasis, which are judged to have an effect on the evaluation.
Exclude criteria