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Completed

NCT Number: NCT00769119

A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral 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).

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Chemin Sainte-Foy, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9668

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: NEPAL

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2008
Registry last updated
Aug 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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