Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Main Inclusion Criteria:

• Persistent bronchial asthma

• No change in asthma treatment within 4 weeks prior to visit 1

• Non-smoker or ex-smoker (for 12 months or longer)

Main Exclusion Criteria:

• Poorly controlled asthma or seasonal asthma

• History of lower airway infection four weeks prior to visit 1

• Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease

• Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1

• Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection

• Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1

• Patients with chronic heart failure

• Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol

• Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females

• Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study