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

August 14, 2012 updated by: AstraZeneca

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
        • Research Site
      • Montreal, Canada
        • Research Site
      • Ontario, Canada
        • Research Site
      • Vancouver, Canada
        • Research Site
    • Quebec
      • Chemin Sainte-Foy, Quebec, Canada
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom
        • Research Site
      • Cambridge, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • New Castle, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AZD9668 active treatment
Drug: AZD9668
2 x 30 mg, oral tablet, twice daily for 28 days
Placebo Comparator: AZD9668 placebo treatment
Drug: Placebo
2 x Matched placebo, oral tablet, twice daily for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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)
Time Frame: Baseline and day 28
Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28
Baseline and day 28
Slow Vital Capacity (SVC)
Time Frame: Baseline and day 28
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)
Time Frame: Baseline and day 28
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)
Time Frame: Baseline and day 28
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%)
Time Frame: Baseline and day 28
FEF25-75% as a measure of lung function.Change from baseline to day 28
Baseline and day 28
Morning Peak Expiratory Flow (PEF)
Time Frame: Last 7 days on treatment
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)
Time Frame: Last 7 days on treatment
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
Time Frame: Last 7 days on treatment
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)
Time Frame: Baseline and day 28
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline
Time Frame: Baseline and day 28
Ratio of day 28 to baseline
Baseline and day 28
Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline
Time Frame: Baseline and day 28
Ratio of day 28 to baseline
Baseline and day 28
Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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 Interleukin 6 (IL-6) at End of Treatment Compared to Baseline
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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 Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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 Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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 Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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 Interleukin 8 (IL-8) at End of Treatment Compared to Baseline
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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 Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline
Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stockley, Prof, Queen Elizabeth Hospital, Birmingham, England
  • Study Director: Carin Jorup, AstraZeneca R&D Lund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D0520C00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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