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

Bronchiectasis Clinical Trial

— NEPAL  

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 Bronchiectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769119
• Other study ID #: D0520C00010
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2008
• Last updated: August 14, 2012
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited 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 Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

• Bronchiectasis

Intervention

Drug:
• AZD9668
2 x 30 mg, oral tablet, twice daily for 28 days
• Placebo
2 x Matched placebo, oral tablet, twice daily for 28 days

Locations

Country	Name	City	State
Canada	Research Site	Calgary
Canada	Research Site	Chemin Sainte-Foy	Quebec
Canada	Research Site	Montreal
Canada	Research Site	Ontario
Canada	Research Site	Vancouver
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	London
United Kingdom	Research Site	New Castle

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.	No
Primary	Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.	No
Primary	24-hour Sputum Weight(g)	Sputum weight (g) collected during 24 hour periods.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 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	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	Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)	FEF25-75% 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 mean 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 mean baseline value to mean of the last 7 days on treatment	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.	Last 7 days on treatment	No
Primary	St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)	SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.	Baseline and day 28	No
Secondary	Ratio of Tumour Necrosis Factor Alpha (TNF a) at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.	No
Secondary	Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.	No
Secondary	Ratio of Interleukin 1 Beta (IL-1ß) at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.	No
Secondary	Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.	No
Secondary	Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.	No
Secondary	Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.	No
Secondary	Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline	Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits	End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 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