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

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 
Overall Participants Analyzed 
[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


  Other 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.


Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Roflumilast   Placebo
Total, other (not including serious) adverse events     
# participants affected / at risk   106/374 (28.34%)   76/369 (20.60%) 
Gastrointestinal disorders     
Diarrhoea † 1     
# participants affected / at risk   33/374 (8.82%)   2/369 (0.54%) 
# events   38   2 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   21/374 (5.61%)   20/369 (5.42%) 
# events   24   23 
Investigations     
Weight decreased † 1 [3]     
# participants affected / at risk   20/374 (5.35%)   2/369 (0.54%) 
# events   20   2 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1 [3]     
# participants affected / at risk   54/374 (14.44%)   63/369 (17.07%) 
# events   64   80 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (11.0)
[3] non-serious



  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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