NCT00769119

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

July 25, 2012

Completed
Last Updated

August 20, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

October 6, 2008

Results QC Date

January 24, 2012

Last Update Submit

August 14, 2012

Conditions

Bronchiectasis

Keywords

bronchiectasisPhase II

Outcome Measures

Primary Outcomes (11)

  • 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.

  • 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.

  • 24-hour Sputum Weight(g)

    Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28

    Baseline and day 28

  • Slow Vital Capacity (SVC)

    Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28

    Baseline and day 28

  • 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

  • Forced Vital Capacity (FVC)

    Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28

    Baseline and day 28

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (9)

  • Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline

    End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

  • Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline

    End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

  • Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline

    End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

  • Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline

    End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

  • Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline

    End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

  • +4 more secondary outcomes

Study Arms (2)

AZD9668 active treatment

EXPERIMENTAL
Drug: AZD9668

AZD9668 placebo treatment

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD9668DRUG

2 x 30 mg, oral tablet, twice daily for 28 days

AZD9668 active treatment
PlaceboDRUG

2 x Matched placebo, oral tablet, twice daily for 28 days

AZD9668 placebo treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female of non child bearing potential
  • Clinical diagnosis of bronchiectasis
  • Be sputum producers, with history of chronic expectoration on most days

You may not qualify if:

  • Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD
  • FEV1 of \<30% of predicted normal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Chemin Sainte-Foy, Quebec, Canada

Location

Research Site

Calgary, Canada

Location

Research Site

Montreal, Canada

Location

Research Site

Ontario, Canada

Location

Research Site

Vancouver, Canada

Location

Research Site

Birmingham, United Kingdom

Location

Research Site

Cambridge, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Newcastle, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23433769DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

N-((5-(methanesulfonyl)pyridin-2-yl)methyl)-6-methyl-5-(1-methyl-1H-pyrazol-5-yl)-2-oxo-1-(3-(trifluoromethyl)phenyl)-1,2-dihydropyridine-3-carboxamide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Stockley, Prof

    Queen Elizabeth Hospital, Birmingham, England

    PRINCIPAL INVESTIGATOR

  • Carin Jorup

    AstraZeneca R&D Lund

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 8, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 20, 2012

Results First Posted

July 25, 2012

Record last verified: 2012-08

Locations

GB(4)CA(5)