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Status unknownNCT03050424ICE-TUpdated May 12, 2017

Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial

A Phase 2 interventional study of Ferric Carboxymaltose and Sodium Chloride 0.9% in Chronic Obstructive Pulmonary Disease, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-05-12.

Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the detailed description

Iron deficiency (ID) is one of the most common nutritional deficiencies affecting humans. Chronic diseases, including COPD, are commonly complicated by iron deficiency anaemia (IDA). It has been well documented that there is an association between both ID and anaemia and reduced exercise capacity. It has been postulated that addressing this ID may be a novel approach to improve exercise capacity and quality of life.

The ECLIPSE cohort found that the prevalence of anaemia in patients with COPD is 19% and is associated with functional limitation and poor outcomes; similarly Nickol et al (2015) found ID to be prevalent in 17.7% of patients with COPD.

Barberan-Garcia et al (2015) evaluated the relationship between Non-anaemic iron deficiency (NAID) and aerobic capacity in seventy COPD patients before and after an 8 week high intensity endurance exercise training programme. Endurance time was assessed as endurance time during constant work rate exercise testing at 80% of oxygen consumption (VO2) peak. At baseline it was noted that the NAID group in comparison to the normal iron status group had a lower exercise tolerance of approximately 90 seconds, which is close to normally reported minimal clinical important difference (MCID's) for this test, P=0.007. After adjusting for confounding variables with a multiple regression analysis it was shown that training induced increase in aerobic exercise capacity was only found in the normal iron status group, with the effect of training on exercise tolerance being lower in the NAID (P=0.041).

Exercise capacity in COPD is strongly linked to outcome measures and mortality. The benefit of correcting NAID in COPD subjects would be to achieve an increase in exercise endurance and thus an improvement in Quality of Life (QoL). Currently there is no standard treatment for NAID in COPD, so this pilot, randomised, double-blind, placebo-controlled trial will attempt to answer this question.

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Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • Iron
  • Exercise Capacity
  • Non-anaemic iron deficiency
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 40 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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
  2. Non-anaemic: males haemoglobin (Hb) ≥ 130g/L, and females ≥ 120g/L

  3. Iron deficiency, defined as:

    1. Serum Ferritin \< 100 µg/ml
    2. Serum Ferritin 100-299 µg/ml with Transferrin saturation (TSAT) \< 16%
    3. Soluble transferring receptor > 28.1nmol/L
  4. No history of lower respiratory tract infection or exacerbation of COPD in the last 6 weeks
  5. No participation in Pulmonary Rehabilitation (PR) for at least 3 months prior to initial assessment.

Exclusion criteria

Exclusion Criteria:

  1. Polycythemia defined as Hb > 170g/L and haematocrit > 0.6 in males and Hb > 150g/L and haematocrit > 0.56 in females.
  2. Significant co-morbidity contributing to reduced exercise tolerance
  3. Congestive cardiac failure defined as Left Ventricular Ejection Fraction (LVEF) \< 45% or plasma B-type natriuretic peptide (BNP) > 100pg/ml.
  4. Oral iron therapy at doses > 100mg/day in the previous week prior to randomisation.
  5. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of normal range.
  6. Anaemia (WHO [31]) defined as Hb \< 130g/L in males > 15 yrs old and Hb \< 120g/L in non-pregnant females.
  7. Current malignancy or haematological disorders.
  8. Currently receiving systemic chemotherapy and/or radiotherapy.
  9. Renal dialysis (previous, current or planned).
  10. Unstable angina.
  11. Subject is of child-bearing potential or is pregnant or breast feeding.

  12. Contraindication to Ferrous Carboxymaltose (Ferinject):

    1. Hypersensitivity to active substance
    2. Known serious hypersensitivity to other parental iron substance
    3. Anaemia not attributed to iron deficiency (e.g. other microcytic anaemia)
    4. Evidence of iron overload or disturbance in utilisation of iron.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Active

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

    Drug: Ferric Carboxymaltose

  • Placebo comparator
    Placebo

    Sodium Chloride 0.9%

    Drug: Sodium Chloride 0.9%

Interventions

  • DrugFerric Carboxymaltose

    Ferric Carboxymaltose injectable Product

    Also known as: Ferinject®

  • DrugSodium Chloride 0.9%

    Sodium Chloride 0.9%

06

What researchers measure

Primary outcomes

  1. Constant Rate Cycle Ergometry (75% Max Load)

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

    Time frame: 8 weeks

Secondary outcomes

  1. Quality of Life

    COPD Assessment Test (CAT)

    Time frame: Week 0; Week 8; Week 10; Week 14

  2. Quality of Life

    Medical Research Council (MRC) Dyspnoea Scale

    Time frame: Week 0; Week 8; Week 10; Week 14

  3. Quality of Life

    Hospital Anxiety and Depression (HAD) Scale

    Time frame: Week 0; Week 8; Week 10; Week 14

  4. Quality of Life

    Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

    Time frame: Week 0; Week 8; Week 10; Week 14

  5. Quality of Life

    EuroQoL Group (EQ-5D-5L)

    Time frame: Week 0; Week 8; Week 10; Week 14

  6. Muscle Oxygen Delivery

    Near infrared spectroscopy during muscle contraction

    Time frame: Week 0; Week 8; Week 14

  7. Endurance Shuttle Walk Test (ESWT)

    Change in endurance shuttle walk test distance and time

    Time frame: Week 0; Week 4; Week 10; Week 14

  8. Adverse Effects of Iron Administration

    Any adverse effects of intravenous iron administration

    Time frame: Week 0; Week 4; Week 8; Week 10; Week 14

07

Study locations

1 of 1 sites recruiting
  • Royal Brompton & Harefield NHS Foundation Trust
    London, SW3 6HP, United Kingdom
    • Matthew Pavitt, MBBS, MRCP · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 28137918 ↗
  • 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. PubMed 27999170 ↗
  • 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. PubMed 27911566 ↗
  • 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. PubMed 26974332 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03050424
Lead sponsor
Royal Brompton & Harefield NHS Foundation Trust
Responsible party
Sponsor
First posted
Feb 10, 2017
Start date
Apr 1, 2017
Primary completion
Oct 1, 2018 (estimated)
Completion
Jan 1, 2019 (estimated)
Last update
May 12, 2017

Study contacts

Matthew Pavitt, MBBS, MRCP
Contact
M.Pavitt@rbht.nhs.uk
0207 351 8029
Michael Polkey, MRCP, PhD
principal investigator · Royal Bromtpon and Harefield NHS Foundation Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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