Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00424268
First received: January 18, 2007
Last updated: May 4, 2012
Last verified: August 2011
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Roflumilast
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Roflumilast Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
Placebo Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled

Participant Flow:   Overall Study
    Roflumilast     Placebo  
STARTED     371 [1]   372 [1]
COMPLETED     309     333  
NOT COMPLETED     62     39  
[1] Includes all randomized patients who took at least one dose of the investigational drug.



  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.
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Reporting Groups
  Description
Roflumilast Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
Placebo Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
Total Total of all reporting groups

Baseline Measures
    Roflumilast     Placebo     Total  
Number of Participants  
[units: participants]
  371     372     743  
Age  
[units: years]
Mean ± Standard Deviation
  64.2  ± 9.1     64.0  ± 9.3     64.1  ± 9.2  
Gender  
[units: participants]
     
Female     109     105     214  
Male     262     267     529  



  Outcome Measures
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1.  Primary:   Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)   [ Time Frame: Change from baseline over 24 weeks of treatment ]

2.  Secondary:   Post-bronchodilator FEV1   [ Time Frame: Change from baseline over 24 weeks of treatment ]

3.  Secondary:   COPD Exacerbation Rate (Moderate or Severe)   [ Time Frame: 24 weeks treatment period ]

4.  Secondary:   Transition Dyspnea Index (TDI) Focal Score   [ Time Frame: Change from baseline over 24 weeks of treatment ]

5.  Secondary:   Shortness of Breath Questionnaire (SOBQ) Total Score   [ Time Frame: Change from baseline over 24 weeks of treatment ]


  Serious Adverse Events
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Time Frame 24 weeks treatment period
Additional Description

The Safety Set was based on all randomized patients who took at least one dose of the investigational drug after randomization.

Three patients randomized to placebo received roflumilast instead and were included in the roflumilast group for safety analyses.


Reporting Groups
  Description
Roflumilast Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
Placebo Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled

Serious Adverse Events
    Roflumilast     Placebo  
Total, serious adverse events      
# participants affected / at risk     22/374 (5.88%)     21/369 (5.69%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     1/374 (0.27%)     1/369 (0.27%)  
# events     1     1  
Lymphoid tissue hyperplasia † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Cardiac disorders      
Angina pectoris † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Atrioventricular block complete † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Cardiac failure † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Myocardial infarction † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Ventricular tachycardia † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Eye disorders      
Retinal artery embolism † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Haematochezia † 1    
# participants affected / at risk     2/374 (0.53%)     0/369 (0.00%)  
# events     2     0  
Colitis † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Colonic polyp † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Duodenal ulcer † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Gastric ulcer † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Inguinal hernia † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
General disorders      
Chest pain † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Hepatobiliary disorders      
Bile duct stone † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Infections and infestations      
Appendicitis † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Perianal abscess † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Pneumonia † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Injury, poisoning and procedural complications      
Contusion † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Post procedural myocardial infarction † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Spinal compression fracture † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Investigations      
Weight decreased † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Musculoskeletal and connective tissue disorders      
Metatarsalgia † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
B-cell lymphoma † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Bladder cancer † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Meningioma † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Metastatic neoplasm † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Non-small cell lung cancer † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Pancreatic neoplasm † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Nervous system disorders      
Cerebral ischaemia † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Cerebrovascular accident † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Guillain-Barre syndrome † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Psychiatric disorders      
Confusional state † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Renal and urinary disorders      
Renal failure chronic † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Respiratory, thoracic and mediastinal disorders      
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     4/374 (1.07%)     5/369 (1.36%)  
# events     4     5  
Pneumothorax † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Pulmonary fibrosis † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Sleep apnoea syndrome † 1    
# participants affected / at risk     0/374 (0.00%)     1/369 (0.27%)  
# events     0     1  
Surgical and medical procedures      
Vascular operation † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Vascular disorders      
Aortic aneurysm † 1    
# participants affected / at risk     1/374 (0.27%)     0/369 (0.00%)  
# events     1     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (11.0)




  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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