NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Chronic obstructive pulmonary disease
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	>= 40age old
Age maximum	Not applicable
Gender	Both
Include criteria	[Inclusion criteria] Patients with chronic obstructive pulmonary disease who are 40 years old or more, current smoker or ex-smoker, 30 to 80 % of predicted FEV1 after inhalation of short acting beta stimulant. [Exclusion criteria] Patients with poorly controlled COPD, patients who need for long-term oxygen therapy, patients who have concurrent respiratory diseases such as asthma, diffuse panbronchiolitis, congenital sinobronchial syndrome, bronchiolitis obliterans, bronchiectasis, active tuberculosis, pneumoconiosis, pulmonary lymph vascular myaoma), which are considered to affect the evaluation.
Exclude criteria