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

January 18, 2007
May 4, 2012
January 2007
January 2008   (final data collection date for primary outcome measure)
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
Lung function
Complete list of historical versions of study NCT00424268 on ClinicalTrials.gov Archive Site
  • Post-bronchodilator FEV1 [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
    Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
  • COPD Exacerbation Rate (Moderate or Severe) [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: No ]

    Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year.

    A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].

  • Transition Dyspnea Index (TDI) Focal Score [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]

    The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked:

    • Functional Impairment
    • Magnitude of Task
    • Magnitude of Effort

    At each of the post-randomization visits questions from the TDI were asked related to 3 components:

    Change in

    • Functional Impairment
    • Magnitude of Task
    • Magnitude of Effort

    Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.

  • Shortness of Breath Questionnaire (SOBQ) Total Score [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]

    Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living.

    The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient.

    For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity".

Other spirometry parameters; COPD symptoms; safety and tolerability.
Not Provided
Not Provided
 
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study

The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Roflumilast
    500 µg, once daily, oral administration in the morning
  • Drug: Placebo
    once daily
  • Active Comparator: Roflumilast

    Roflumilast 500 µg

    underlying medication: tiotropium 18 µg, once daily, inhaled

    Intervention: Drug: Roflumilast
  • Placebo Comparator: Placebo

    Placebo

    underlying medication: tiotropium 18 µg, once daily, inhaled

    Intervention: Drug: Placebo
Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
743
July 2008
January 2008   (final data collection date for primary outcome measure)

Main Inclusion Criteria:

  • History of COPD for at least 12 months prior to baseline visit and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
  • FEV1/FVC ratio (post-bronchodilator) ≤ 70%
  • FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
  • Treated with tiotropium for at least 3 months before enrollment
  • At least 28 puffs of rescue medication during last week prior to randomization

Main Exclusion Criteria:

  • COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Hungary,   Italy,   Spain,   United Kingdom
 
NCT00424268
BY217/M2-128, 2006-004508-37
No
Nycomed
Takeda
Not Provided
Principal Investigator: Prof. L M Fabbri University of Modena & Reggio Emilia, Department of Respiratory Diseases, Italy
Takeda
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP