Clinical trial NCT00769119: A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bronchiectasis
Keywords: bronchiectasis
Phase II
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: 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 Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).


Eligibility criteria: 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

Primary outcomes:
measure: Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
measure: Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
measure: 24-hour Sputum Weight(g)
timeFrame: Baseline and day 28
measure: Slow Vital Capacity (SVC)
timeFrame: Baseline and day 28
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline and day 28
measure: Forced Vital Capacity (FVC)
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: Morning Peak Expiratory Flow (PEF)
timeFrame: Last 7 days on treatment
measure: Evening Peak Expiratory Flow (PEF)
timeFrame: Last 7 days on treatment
measure: Bronkotest Diary Card Signs and Symptoms
timeFrame: Last 7 days on treatment
measure: St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)
timeFrame: Baseline and day 28
Secondary outcomes:
measure: Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
measure: Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
measure: Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
measure: Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
measure: Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
measure: Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
measure: Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline
timeFrame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 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: Chemin Sainte-Foy
country: Canada
facility: Research Site
state: Quebec
city: Calgary
country: Canada
facility: Research Site
city: Montreal
country: Canada
facility: Research Site
city: Ontario
country: Canada
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: New Castle
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Queen Elizabeth Hospital, Birmingham, England
name: Stockley, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Lund
name: Carin Jorup
role: STUDY_DIRECTOR
References:
citation: Stockley R, De Soyza A, Gunawardena K, Perrett J, Forsman-Semb K, Entwistle N, Snell N. Phase II study of a neutrophil elastase inhibitor (AZD9668) in patients with bronchiectasis. Respir Med. 2013 Apr;107(4):524-33. doi: 10.1016/j.rmed.2012.12.009. Epub 2013 Feb 20.