Research with human participants

Overview of medical research in the Netherlands

Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972)

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Last updated:

Effect on bone mineral density.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Bone disorders (excl congenital and fractures)
Study type
Interventional

ID

NL-OMON44651

Source

ToetsingOnline

Brief title

HZC102972

Condition

  • Bone disorders (excl congenital and fractures)
  • Respiratory disorders NEC

Synonym

COPD; chronic obstructive pulmonary disease

Research involving

Human

Sponsors and support

Primary sponsor :
GlaxoSmithKline BV
Source(s) of monetary or material Support :
GlaxoSmithKline BV

Intervention

Keyword :
BMD, COPD, Corticosteroids, Inhaled

Outcome measures

Primary outcome

Bone mineral density hip.

Secondary outcome

Bone mineral density lumbar spine. Adverse events.

Background summary

Although inhaled corticosteroids have demonstrated utility in patients with
COPD, there is a potential safety concern with long-term use of ICS on bone
demineralization. These concerns, for the most part, are derived from the
well-documented effects of oral corticosteroids on bone density and fracture;
however the actual effects of inhaled corticosteroids are not clear and require
further study.
Study HZC102972 will prospectively assess the effects of 3 years (156 weeks)
exposure to Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder versus VI
on bone mineral density in adult subjects with COPD.
Fluticasone is an inhaled corticosteroid and vilanterol is a long acting ß2-
agonist. The combination has recently been registered in the EU.

Study objective

Effect on bone mineral density.

Study design

Multicenter randomized double blind phase IV parallel group study. Single-blind
run-in period of 2-3 weeks.
Randomisation (1:1) to treatment with:
* Fluticasone Furoate /Vilanterol (100/25 mcg) once daily
* Vilanterol (25 mcg) once daily
administration as inhaled dry powder formulation.
Treatment duration approx 3 years.
Approx 280 randomized patients.

Intervention

Treatment with fluticasone furoate/vilanterol or vilanterol.

Study burden and risks

Risk: Adverse effects of study medication.
Burden:
Visits: screening, 1st treatment day, thereafter every 3 months during approx.
3 years. Final telephone consultation. Duration 1-3 hours.
Physical examination: screening, therafter yearly.
Inspection mouth and throat: every visit.
Blood draw 20 ml, ECG, chest X-ray and (if relevant) pregnancy test at
screening.
Pulmonary function test at screening (incl. reversibility) and every 6 months
thereafter.
DEXA scan: screening, thereafter every 6 months.
Daily completion of diary (medication use, concomitant medical problems,
concomitant medication).
Optional pharmacogenetic research (saliva).

Public
GlaxoSmithKline BV

Huis ter Heideweg 62
Zeist 3705 LZ
NL
Scientific
GlaxoSmithKline BV

Huis ter Heideweg 62
Zeist 3705 LZ
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

* COPD patients *40 years of age (see protocol page 16 for details).
* (Ex) smokers, at least 10 pack years.
* Pre and post salbutamol FEV1/FVC ratio <70%.
* Post salbutamol FEV1 *50% and *70% of predicted.
* At least one native hip..
* Safe contraception for women of childbearing potential.

Exclusion criteria

* Pregnancy, lactation.
* Bronchial asthma.
* Poorly controlled COPD (see protocol page 17 for details).
* Bone disorders (see protocol page 17 for details).
* Immobility.
* Low vitamin D (see protocol page 18 for details)
* Use of prohibited medication (see protocol page 19 for details).

Design

Study phase :
4
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
50
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Relvar Ellipta
Generic name :
fluticasone furoate / vilanterol
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
vilanterol
Generic name :
vilanterol

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
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Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
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Approved WMO
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
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MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
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Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
Other clinicaltrials.gov; NCT01957150
EudraCT EUCTR2012-004801-28-NL
CCMO NL46657.060.13