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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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Official Title

Roflumilast 500 µg

underlying medication: tiotropium 18 µg, once daily, inhaled

Placebo 

underlying medication: tiotropium 18 µg, once daily, inhaled

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.

Effect of roflumilast in chronic obstructive pulmonary disease (COPD) patients treated with tiotropium: The HELIOS Study (BY217/M2-128)

NCT ID

Therapeutic Area

500 µg, once daily, oral administration in the morning

Altana Pharma/Nycomed Investigational Site

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

Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]

Age Continuous

Gender, Male/Female

ITT (Intention to Treat) analysis. Number of participants analyzed = number of participants with data available.

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)

Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]

ITT analysis. Number of participants analyzed = number of participants with data available.

Post-bronchodilator FEV1

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].

COPD Exacerbation Rate (moderate or severe)

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.

Transition dyspnea index (TDI) focal score

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".

Arms	Assigned Interventions
Active Comparator: Roflumilast Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled	Drug: Roflumilast 500 µg, once daily, oral administration in the morning
Placebo Comparator: Placebo Placebo underlying medication: tiotropium 18 µg, once daily, inhaled	Drug: Placebo once daily

Effect of roflumilast in chronic obstructive pulmonary disease (COPD) patients treated with tiotropium: The HELIOS Study (BY217/M2-128) - HELIOS

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