NCT03050424

Brief Summary

This phase II single centre, double blind, placebo-controlled, randomised trial aims to test the hypothesis that intravenous iron improves exercise performance in Chronic Obstructive Pulmonary Disease (COPD) as measured by constant rate cycle ergometry.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2017

Typical duration for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

February 7, 2017

Last Update Submit

May 11, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDIronExercise CapacityNon-anaemic iron deficiency

Outcome Measures

Primary Outcomes (1)

  • Constant Rate Cycle Ergometry (75% Max Load)

    Increased exercise capacity as assessed by endurance cycle ergometry at 75% VO2max

    8 weeks

Secondary Outcomes (8)

  • Quality of Life

    Week 0; Week 8; Week 10; Week 14

  • Quality of Life

    Week 0; Week 8; Week 10; Week 14

  • Quality of Life

    Week 0; Week 8; Week 10; Week 14

  • Quality of Life

    Week 0; Week 8; Week 10; Week 14

  • Quality of Life

    Week 0; Week 8; Week 10; Week 14

  • +3 more secondary outcomes

Study Arms (2)

Active

EXPERIMENTAL

Ferric Carboxymaltose (FCM) (Ferinject) at 15 mg iron/kg body weight

Drug: Ferric Carboxymaltose

Placebo

PLACEBO COMPARATOR

Sodium Chloride 0.9%

Drug: Sodium Chloride 0.9%

Interventions

Ferric CarboxymaltoseDRUG

Ferric Carboxymaltose injectable Product

Also known as: Ferinject®
Active
Sodium Chloride 0.9%DRUG

Sodium Chloride 0.9%

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically stable patients (\>18 years old), Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV COPD Forced Expiratory Volume in 1 second (FEV1):Forced Vital capacity (FVC) \< 0.70
  • Non-anaemic: males haemoglobin (Hb) ≥ 130g/L, and females ≥ 120g/L
  • Iron deficiency, defined as:
  • Serum Ferritin \< 100 µg/ml
  • Serum Ferritin 100-299 µg/ml with Transferrin saturation (TSAT) \< 16%
  • Soluble transferring receptor \> 28.1nmol/L
  • No history of lower respiratory tract infection or exacerbation of COPD in the last 6 weeks
  • No participation in Pulmonary Rehabilitation (PR) for at least 3 months prior to initial assessment.

You may not qualify if:

  • Polycythemia defined as Hb \> 170g/L and haematocrit \> 0.6 in males and Hb \> 150g/L and haematocrit \> 0.56 in females.
  • Significant co-morbidity contributing to reduced exercise tolerance
  • Congestive cardiac failure defined as Left Ventricular Ejection Fraction (LVEF) \< 45% or plasma B-type natriuretic peptide (BNP) \> 100pg/ml.
  • Oral iron therapy at doses \> 100mg/day in the previous week prior to randomisation.
  • Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of normal range.
  • Anaemia (WHO \[31\]) defined as Hb \< 130g/L in males \> 15 yrs old and Hb \< 120g/L in non-pregnant females.
  • Current malignancy or haematological disorders.
  • Currently receiving systemic chemotherapy and/or radiotherapy.
  • Renal dialysis (previous, current or planned).
  • Unstable angina.
  • Subject is of child-bearing potential or is pregnant or breast feeding.
  • Contraindication to Ferrous Carboxymaltose (Ferinject):
  • Hypersensitivity to active substance
  • Known serious hypersensitivity to other parental iron substance
  • Anaemia not attributed to iron deficiency (e.g. other microcytic anaemia)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton & Harefield NHS Foundation Trust

London, SW3 6HP, United Kingdom

RECRUITING

Related Publications (4)

  • Demeyer H, Louvaris Z, Frei A, Rabinovich RA, de Jong C, Gimeno-Santos E, Loeckx M, Buttery SC, Rubio N, Van der Molen T, Hopkinson NS, Vogiatzis I, Puhan MA, Garcia-Aymerich J, Polkey MI, Troosters T; Mr Papp PROactive study group and the PROactive consortium. Physical activity is increased by a 12-week semiautomated telecoaching programme in patients with COPD: a multicentre randomised controlled trial. Thorax. 2017 May;72(5):415-423. doi: 10.1136/thoraxjnl-2016-209026. Epub 2017 Jan 30.

    PMID: 28137918BACKGROUND

  • Zoumot Z, Davey C, Jordan S, McNulty WH, Carr DH, Hind MD, Polkey MI, Shah PL, Hopkinson NS. Endobronchial valves for patients with heterogeneous emphysema and without interlobar collateral ventilation: open label treatment following the BeLieVeR-HIFi study. Thorax. 2017 Mar;72(3):277-279. doi: 10.1136/thoraxjnl-2016-208865. Epub 2016 Dec 20.

    PMID: 27999170BACKGROUND

  • Nolan CM, Maddocks M, Canavan JL, Jones SE, Delogu V, Kaliaraju D, Banya W, Kon SSC, Polkey MI, Man WD. Pedometer Step Count Targets during Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 May 15;195(10):1344-1352. doi: 10.1164/rccm.201607-1372OC.

    PMID: 27911566BACKGROUND

  • Demeyer H, Gimeno-Santos E, Rabinovich RA, Hornikx M, Louvaris Z, de Boer WI, Karlsson N, de Jong C, Van der Molen T, Vogiatzis I, Janssens W, Garcia-Aymerich J, Troosters T, Polkey MI; PROactive consortium. Physical Activity Characteristics across GOLD Quadrants Depend on the Questionnaire Used. PLoS One. 2016 Mar 14;11(3):e0151255. doi: 10.1371/journal.pone.0151255. eCollection 2016.

    PMID: 26974332BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

ferric carboxymaltoseSodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Michael Polkey, MRCP, PhD

    Royal Bromtpon and Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Pavitt, MBBS, MRCP

CONTACT

0207 351 8029M.Pavitt@rbht.nhs.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind, placebo-controlled, randomised trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 10, 2017

Study Start

April 1, 2017

Primary Completion

October 1, 2018

Study Completion

January 1, 2019

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)