NCT00424268|CompletedPhase 3Results

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

HELIOS

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

AstraZeneca ClinicalTrials.gov

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2 other identifiers

BY217/M2-1282006-004508-37

Study Type

interventional

Target

743

Locations

7 countries

Sites

103

Timeline

RegisteredJan 2007

StartedJan 2007

CompletionJul 2008

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

743

participants targeted

Target at P50-P75 for phase_3 chronic-obstructive-pulmonary-disease

Timeline

Completed

Started Jan 2007

Geographic Reach

7 countries

103 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

January 1, 2007

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2007

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed

2.9 years until next milestone

Results Posted

Study results publicly available

May 19, 2011

Completed

Last Updated

December 5, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

January 18, 2007

Results QC Date

March 17, 2011

Last Update Submit

October 24, 2016

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDRoflumilast

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Post-bronchodilator FEV1
Change from baseline over 24 weeks of treatment
COPD Exacerbation Rate (Moderate or Severe)
24 weeks treatment period
Transition Dyspnea Index (TDI) Focal Score
Change from baseline over 24 weeks of treatment
Shortness of Breath Questionnaire (SOBQ) Total Score
Change from baseline over 24 weeks of treatment

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR

Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled

Drug: Roflumilast

Placebo

PLACEBO COMPARATOR

Placebo underlying medication: tiotropium 18 µg, once daily, inhaled

Drug: Placebo

Interventions

RoflumilastDRUG

500 µg, once daily, oral administration in the morning

Roflumilast

PlaceboDRUG

once daily

Placebo

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit

Contact the study team to confirm eligibility.