Clinical trial NCT00757848: A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline
timeFrame: Baseline and Values from day 21 to 28
measure: Sputum Percentage Neutrophil Count
timeFrame: Baseline and Values from day 21 to 28
measure: 24-hour Sputum Weight
timeFrame: Baseline and day 28
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline and day 28
measure: Slow Vital Capacity (SVC)
timeFrame: Baseline and day 28
measure: Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)
timeFrame: Baseline and day 28
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline and day 28
measure: Morning Peak Expiratory Flow (PEF)
timeFrame: Last 7 days on treatment
measure: Evening Peak Expiratory Flow (PEF)
timeFrame: The last 7 days on treatment
measure: Bronkotest Diary Card Signs and Symptoms
timeFrame: The last 7 days on treatment
measure: Cystic Fibrosis Questionnaire (CFQ-R) - Quittner
timeFrame: Baseline and day 28
Secondary outcomes:
measure: Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28
measure: Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.
measure: Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits
measure: Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.
measure: Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits
measure: Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits
measure: Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits
measure: Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline
timeFrame: Baseline and day 28
measure: Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline
timeFrame: Baseline and day 28
Other outcomes:
Locations:
city: Kobenhavn
country: Denmark
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Rabka-zdroj
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Liverpool
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Belfast hospital
name: Prof. Elborn
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Joanna Marks-Konczalik
role: STUDY_DIRECTOR
References:
citation: Elborn JS, Perrett J, Forsman-Semb K, Marks-Konczalik J, Gunawardena K, Entwistle N. Efficacy, safety and effect on biomarkers of AZD9668 in cystic fibrosis. Eur Respir J. 2012 Oct;40(4):969-76. doi: 10.1183/09031936.00194611. Epub 2012 Jan 20.