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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00757848
First received: September 22, 2008
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Cystic Fibrosis
 Drug: AZD9668
Drug: AZD9668 Placebo equivalent
 Phase 2

Study Type: 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
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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline [ Time Frame: Baseline and Values from day 21 to 28 ] [ Designated as safety issue: No ]
    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  • Sputum Percentage Neutrophil Count [ Time Frame: Baseline and Values from day 21 to 28 ] [ Designated as safety issue: No ]
    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)

  • 24-hour Sputum Weight [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.

  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.

  • Slow Vital Capacity (SVC) [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.

  • Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.

  • Forced Vital Capacity (FVC) [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.

  • Morning Peak Expiratory Flow (PEF) [ Time Frame: Last 7 days on treatment ] [ Designated as safety issue: No ]
    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

  • Evening Peak Expiratory Flow (PEF) [ Time Frame: The last 7 days on treatment ] [ Designated as safety issue: No ]
    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

  • Bronkotest Diary Card Signs and Symptoms [ Time Frame: The last 7 days on treatment ] [ Designated as safety issue: No ]
    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.

  • Cystic Fibrosis Questionnaire (CFQ-R) - Quittner [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28 ] [ Designated as safety issue: No ]
    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  • Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits. ] [ Designated as safety issue: No ]
    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  • Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits ] [ Designated as safety issue: No ]
    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  • Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits. ] [ Designated as safety issue: No ]
    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  • Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits ] [ Designated as safety issue: No ]
    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  • Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits ] [ Designated as safety issue: No ]
    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  • Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits ] [ Designated as safety issue: No ]
    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  • Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    Ratio of day 28 to baseline

  • Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    Ratio of day 28 to baseline


Enrollment: 56
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD9668 Drug: AZD9668
60 mg, oral tablet, twice daily for 28 days
Placebo Comparator: Placebo Drug: AZD9668 Placebo equivalent
Match placebo to 60 mg, oral tablet, twice daily for 28 days

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757848

Locations
Denmark
Research Site
Kobenhavn, Denmark
Germany
Research Site
Hamburg, Germany
Research Site
Kiel, Germany
Research Site
Leipzig, Germany
Research Site
Munchen, Germany
Poland
Research Site
Rabka-zdroj, Poland
Research Site
Warszawa, Poland
Russian Federation
Research Site
Moscow, Russian Federation
Sweden
Research Site
Goteborg, Sweden
Research Site
Lund, Sweden
Research Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
United Kingdom
Research Site
Belfast, Northern Ireland, United Kingdom
Research Site
Liverpool, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Prof. Elborn Belfast hospital
Study Director: Joanna Marks-Konczalik AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00757848     History of Changes
Other Study ID Numbers: D0520C00009
Study First Received: September 22, 2008
Results First Received: January 24, 2012
Last Updated: August 14, 2012
Health Authority: Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
cystic fibrosis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013