A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— INCA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757848
• Other study ID #: D0520C00009
• Status: Completed
• Phase: Phase 2
• First received: September 22, 2008
• Last updated: August 14, 2012
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesPoland: Ministry of HealthRussia: Ministry of Health of the Russian FederationSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• AZD9668
60 mg, oral tablet, twice daily for 28 days
• AZD9668 Placebo equivalent
Match placebo to 60 mg, oral tablet, twice daily for 28 days

Locations

Country	Name	City	State
Denmark	Research Site	Kobenhavn
Germany	Research Site	Hamburg
Germany	Research Site	Kiel
Germany	Research Site	Leipzig
Germany	Research Site	Munchen
Poland	Research Site	Rabka-zdroj
Poland	Research Site	Warszawa
Russian Federation	Research Site	Moscow
Sweden	Research Site	Goteborg
Sweden	Research Site	Lund
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala
United Kingdom	Research Site	Belfast	Northern Ireland
United Kingdom	Research Site	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Germany,  Poland,  Russian Federation,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline	Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits	Baseline and Values from day 21 to 28	No
Primary	Sputum Percentage Neutrophil Count	Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)	Baseline and Values from day 21 to 28	No
Primary	24-hour Sputum Weight	Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.	Baseline and day 28	No
Primary	Forced Expiratory Volume in 1 Second (FEV1)	Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.	Baseline and day 28	No
Primary	Slow Vital Capacity (SVC)	Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.	Baseline and day 28	No
Primary	Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)	FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.	Baseline and day 28	No
Primary	Forced Vital Capacity (FVC)	Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.	Baseline and day 28	No
Primary	Morning Peak Expiratory Flow (PEF)	Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment	Last 7 days on treatment	No
Primary	Evening Peak Expiratory Flow (PEF)	Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment	The last 7 days on treatment	No
Primary	Bronkotest Diary Card Signs and Symptoms	The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.	The last 7 days on treatment	No
Primary	Cystic Fibrosis Questionnaire (CFQ-R) - Quittner	Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.	Baseline and day 28	No
Secondary	Ratio of Sputum Tumour Necrosis Factor Alpha (TNF a) at End of Treatment Compared to Baseline	Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits	End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28	No
Secondary	Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline	Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits	End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.	No
Secondary	Ratio of Sputum Interleukin 1 Beta (IL-1ß) at End of Treatment Compared to Baseline	Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits	End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits	No
Secondary	Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline	Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits	End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.	No
Secondary	Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline	Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits	End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits	No
Secondary	Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline	Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits	End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits	No
Secondary	Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline	Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits	End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits	No
Secondary	Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline	Ratio of day 28 to baseline	Baseline and day 28	No
Secondary	Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline	Ratio of day 28 to baseline	Baseline and day 28	No