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A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients With Cystic Fibrosis


Phase 2
16 Years
N/A
Not Enrolling
Both
Cystic Fibrosis

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Trial Information

A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients With Cystic Fibrosis


Inclusion Criteria:



- Male or post-menopausal or surgically sterile female patients

- Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or
equal to 40% of normal

- Have normal renal function

Exclusion Criteria:

- Lung transplant patients

- Significant liver disease

- Any other non-CF-related lung disease that may interfere with study assessments

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline

Outcome Description:

Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

Outcome Time Frame:

Baseline and Values from day 21 to 28

Safety Issue:

No

Principal Investigator

Prof. Elborn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Belfast hospital

Authority:

Denmark: Danish Medicines Agency

Study ID:

D0520C00009

NCT ID:

NCT00757848

Start Date:

October 2008

Completion Date:

August 2009

Related Keywords:

  • Cystic Fibrosis
  • cystic fibrosis
  • Cystic Fibrosis
  • Fibrosis

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