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Completed

NCT Number: NCT01255592

Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis

The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Lung Disease Lung Diseases Respiration Disorders Respiratory Diseases Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Ostrava, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
  • Aged 18 to 80 years inclusive at screening (Visit 1)
  • Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
  • Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more.
  • Be on a stable treatment regimen, as judged by the investigator.

Exclusion criteria

  • Any clinically significant disease or disorder
  • Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
  • An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
  • An FEV1 of <30% of predicted normal at Visit 1
  • Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
  • Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis
  • Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate

Treatment and study plan

AZD5069

Drug

Oral dose bid

Placebo

Drug

Oral dose bid

Primary outcomes

  1. Ratio of Absolute Neutrophil Cell Count in Sputum 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.

Secondary outcomes

  1. Ratio of the Percentage Neutrophil Cell Count in Sputum 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. Change From Baseline in Weight of 24-hour Sputum Collection

    Time frame: Baseline and end of treatment (Day 28)

    Patients collected all sputum produced during a 24-hour period at baseline and Day 28.

  3. Change From Baseline in Slow Vital Capacity (SVC)

    Time frame: Baseline to end of treatment (Day 28)

    Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.

  4. Change From Baseline in Forced Vital Capacity (FVC)

    Time frame: Baseline to end of treatment (Day 28)

    Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.

  5. Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline to end of treatment (Day 28)

    Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.

  6. Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)

    Time frame: Baseline to end of treatment (Day 28)

    Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).

  7. Transition Dyspnea Index (TDI) at End of Treatment (Day 28)

    Time frame: Baseline to end of treatment (Day 28)

    TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.

  8. Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card

    Time frame: Baseline and Last 7 days on treatment

    The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.

  9. Change From Baseline for the Symptom Scores of the Bronkotest Diary Card

    Time frame: Baseline and Last 7 days on treatment

    The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.

  10. Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)

    Time frame: Baseline and end of treatment (Day 28)

    SGRQ-C 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). The SGRQ-C contains 3 domains:

    Symptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status).

  11. Ratio of Interleukin-1 Beta (IL-1β) in Sputum 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.

  12. Ratio of Interleukin-6 (IL-6) in Sputum 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.

  13. Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum 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.

  14. Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum 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.

  15. Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum 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.

  16. Ratio of Growth-related Oncogene-α (GRO-α) in Sputum 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.

  17. Ratio of Interleukin-8 (IL-8) in Sputum 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.

  18. Ratio of Neutrophil Elastase Activity in Sputum 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.

  19. Ratio of Serum Amyloid A (SAA) in Serum 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.

  20. Ratio of C-reactive Protein (CRP) in Serum 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.

  21. Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum 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.

  22. Ratio of Growth-related Oncogene-α (GRO-α) in Serum 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.

  23. Ratio of Interleukin-6 (IL-6) in Serum 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.

  24. Ratio of Interleukin-1 Beta (IL-1β) in Serum 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.

  25. Ratio of Interleukin-8 (IL-8) in Serum 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.

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 AZD5069 Twice Daily in Patients With Bronchiectasis

Acronym: STRATUS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2010
Registry last updated
Oct 8, 2015

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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