A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis (NEPAL)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Bronchiectasis

Treatments: Drug: Placebo; Drug: AZD9668

Study type: Interventional

Funder types: Industry

Identifiers

NCT00769119

D0520C00010

Details and patient eligibility

About

The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female of non child bearing potential
• Clinical diagnosis of bronchiectasis
• Be sputum producers, with history of chronic expectoration on most days

Exclusion criteria

• Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD
• FEV1 of <30% of predicted normal

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

AZD9668 active treatment

Experimental group

Treatment:

Drug: AZD9668

AZD9668 placebo treatment

Placebo Comparator group

Treatment:

Drug: Placebo