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Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis (STRATUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01255592
First received: December 2, 2010
Last updated: September 7, 2015
Last verified: September 2015
Results First Received: June 25, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Bronchiectasis
Lung Disease
Respiratory Diseases
Interventions: Drug: AZD5069
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This multicenter study was conducted in Europe between 27 December 2010 and 13 February 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AZD5069 AZD5069 80 mg bd
Placebo Placebo for AZD5069, bd

Participant Flow:   Overall Study
    AZD5069     Placebo  
STARTED     26     26  
COMPLETED     20     25  
NOT COMPLETED     6     1  
Adverse Event                 5                 0  
Withdrawal by Subject                 1                 0  
Other                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD5069 AZD5069 80 mg bd
Placebo Placebo bd
Total Total of all reporting groups

Baseline Measures
    AZD5069     Placebo     Total  
Number of Participants  
[units: participants]
  26     26     52  
Age  
[units: years]
Mean (Standard Deviation)
  66  (6.6)     65  (8.8)     65  (7.7)  
Gender  
[units: participants]
     
Female     16     12     28  
Male     10     14     24  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     0     0     0  
Black or African American     0     0     0  
White     26     26     52  
Other     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   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. ]

3.  Secondary:   Change From Baseline in Weight of 24-hour Sputum Collection   [ Time Frame: Baseline and end of treatment (Day 28) ]

4.  Secondary:   Change From Baseline in Slow Vital Capacity (SVC)   [ Time Frame: Baseline to end of treatment (Day 28) ]

5.  Secondary:   Change From Baseline in Forced Vital Capacity (FVC)   [ Time Frame: Baseline to end of treatment (Day 28) ]

6.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Baseline to end of treatment (Day 28) ]

7.  Secondary:   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) ]

8.  Secondary:   Transition Dyspnea Index (TDI) at End of Treatment (Day 28)   [ Time Frame: Baseline to end of treatment (Day 28) ]

9.  Secondary:   Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card   [ Time Frame: Baseline and Last 7 days on treatment ]

10.  Secondary:   Change From Baseline for the Symptom Scores of the Bronkotest Diary Card   [ Time Frame: Baseline and Last 7 days on treatment ]

11.  Secondary:   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) ]

12.  Secondary:   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. ]

13.  Secondary:   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. ]

14.  Secondary:   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. ]

15.  Secondary:   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. ]

16.  Secondary:   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. ]

17.  Secondary:   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. ]

18.  Secondary:   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. ]

19.  Secondary:   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. ]

20.  Secondary:   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. ]

21.  Secondary:   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. ]

22.  Secondary:   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. ]

23.  Secondary:   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. ]

24.  Secondary:   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. ]

25.  Secondary:   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. ]

26.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01255592     History of Changes
Other Study ID Numbers: D3550C00014
Study First Received: December 2, 2010
Results First Received: June 25, 2015
Last Updated: September 7, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products