Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: AZD9668

Study type: Interventional

Funder types: Industry

Identifiers

NCT01023516

D0520C00020

Details and patient eligibility

About

The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD

Enrollment: 615 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD with symptoms over 1 year
• FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator
• Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
• At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit

Exclusion criteria

• Past history or current evidence of clinically significant heart disease
• Current diagnosis of asthma
• Patients who require long term oxygen therapy
• Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

615 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD9668

2

Placebo Comparator group

Treatment:

Drug: Placebo