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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Placebo; Drug: Roflumilast

• Registration Number: NCT00424268
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-18
• Study First Submitted QC: 2007-01-18
• Study First Posted: 2007-01-19
• Primary Completion: 2008-01
• Study Completion: 2008-07
• Results First Submitted: 2011-03-17
• Results First Submitted QC: 2011-04-20
• Results First Posted: 2011-05-19
• Status Verified: 2016-09
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 743

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo underlying medication: tiotropium 18 µg, once daily, inhaled
Roflumilast	Roflumilast	Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled

Primary Outcome Measures

Name	Time	Method
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Change from baseline over 24 weeks of treatment	Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]

Secondary Outcome Measures

Name	Time	Method
Post-bronchodilator FEV1	Change from baseline over 24 weeks of treatment	Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
COPD Exacerbation Rate (Moderate or Severe)	24 weeks treatment period	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	Change from baseline over 24 weeks of treatment	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	Change from baseline over 24 weeks of treatment	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".

Trial Locations

Locations (1)

Altana Pharma/Nycomed Investigational Site; 🇬🇧 Yaxley, United Kingdom