Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01047553
First received: January 12, 2010
Last updated: December 4, 2012
Last verified: December 2012
Results First Received: July 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Intervention: Drug: Formoterol (OT)

  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
The first participant entered the study on 18 December 2009, and the last participant completed the study on 20 July 2011. A total of 320 participants were enrolled at 30 centers in Japan, and 251 participants who fulfilled the randomization criteria were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study started with an enrolment visit, Visit 1, 1 week prior to Visit 2, and 1 week run-in period before randomization. At Visit 2 participants had to have pre-bronchodilatory forced expiratory volume in one second (FEV1) less than 80 percent of the predicted normal value.

Reporting Groups
  Description
Formoterol Formoterol 9 μg twice daily
Standard Treatment Standard COPD (JRS guideline and GOLD) treatment

Participant Flow:   Overall Study
    Formoterol     Standard Treatment  
STARTED     125     126  
COMPLETED     108     117  
NOT COMPLETED     17     9  
Adverse Event                 10                 5  
Withdrawal by Subject                 4                 2  
Development of Study-Specific Withdrawal                 1                 1  
Lost to Follow-up                 1                 0  
Sever Non-Compliance to Protocol                 1                 0  
PI's decision                 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
Formoterol Formoterol 9 μg twice daily
Standard Treatment Standard COPD (JRS guideline and GOLD) treatment
Total Total of all reporting groups

Baseline Measures
    Formoterol     Standard Treatment     Total  
Number of Participants  
[units: participants]
  125     126     251  
Age  
[units: Years]
Mean ( Full Range )
  70.8  
  ( 43 to 88 )  
  70.3  
  ( 50 to 83 )  
  70.6  
  ( 43 to 88 )  
Gender  
[units: Participants]
     
Female     6     9     15  
Male     119     117     236  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Laboratory Test: Haematology -Erythrocytes   [ Time Frame: Baseline and week 52 ]

2.  Primary:   Clinical Laboratory Test: Haematology -Haemoglobin   [ Time Frame: Baseline and week 52 ]

3.  Primary:   Clinical Laboratory Test: Haematology-Leucocytes   [ Time Frame: Baseline and week 52 ]

4.  Primary:   Clinical Laboratory Test: Haematology-Platelet Count   [ Time Frame: Baseline and week 52 ]

5.  Primary:   Clinical Laboratory Test: Haematology Eosinophils   [ Time Frame: baseline and week 52 ]

6.  Primary:   Clinical Laboratory Test: Haematology Basophil   [ Time Frame: Baseline and week 52 ]

7.  Primary:   Clinical Laboratory Test: Haematology-Lymphocytes   [ Time Frame: Baseline and week 52 ]

8.  Primary:   Clinical Laboratory Test: Haematology-Monocytes   [ Time Frame: Baseline and week 52 ]

9.  Primary:   Clinical Laboratory Test: Haematology -Neutrophils   [ Time Frame: Baseline and week 52 ]

10.  Primary:   Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase   [ Time Frame: Baseline and week 52 ]

11.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase   [ Time Frame: Baseline and week 52 ]

12.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)   [ Time Frame: Baseline and week 52 ]

13.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S-Creatinine   [ Time Frame: Baseline and week 52 ]

14.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin   [ Time Frame: Baseline and week 52 ]

15.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S-Sodium   [ Time Frame: Baseline and week 52 ]

16.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S-Potassium   [ Time Frame: Baseline and week 52 ]

17.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S- Calcium   [ Time Frame: Baseline and week 52 ]

18.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S-Albumin   [ Time Frame: Baseline and week 52 ]

19.  Primary:   Clinical Laboratory Test: Clinical Chemistry-S-Total Protein   [ Time Frame: Baseline and week 52 ]

20.  Primary:   Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)   [ Time Frame: Baseline and week 52 ]

21.  Primary:   Vital Signs- Sitting SBP   [ Time Frame: Baseline and week 52 ]

22.  Primary:   Vital Signs- Sitting DBP   [ Time Frame: Baseline and week 52 ]

23.  Primary:   Vital Signs - Pulse Rate   [ Time Frame: Baseline and week 52 ]

24.  Primary:   ECG Variables - Heart Rate   [ Time Frame: Baseline and week 52 ]

25.  Primary:   ECG Variables - QT Interval   [ Time Frame: Baseline and week 52 ]

26.  Primary:   ECG Variables - QTcB Interval   [ Time Frame: Baseline and week 52 ]

27.  Primary:   ECG Variables QTcF Interval   [ Time Frame: Baseline and week 52 ]

28.  Primary:   ECG Variables RR Interval   [ Time Frame: Baseline and week 52 ]

29.  Secondary:   Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization ]

30.  Secondary:   Forced Vital Capacity (FVC)   [ Time Frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization ]

31.  Secondary:   Morning Peak Expiratory Flow(PEF)   [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment ]

32.  Secondary:   Evening Peak Expiratory Flow (PEF)   [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment ]

33.  Secondary:   Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms   [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ]

34.  Secondary:   Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms   [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ]

35.  Secondary:   Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms   [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment ]

36.  Secondary:   Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score   [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ]

37.  Secondary:   Number of COPD Exacerbations Over the Treatment Period   [ Time Frame: Daily during 52-week randomization treatment ]

38.  Secondary:   Use of SABA (Salbutamol) as Reliever Medication   [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ]

39.  Secondary:   St George’s Respiratory Questionnaire (SGRQ) Total Score   [ Time Frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment ]


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01047553     History of Changes
Other Study ID Numbers: D5122C00002
Study First Received: January 12, 2010
Results First Received: July 18, 2012
Last Updated: December 4, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency