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Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial (ICE-T)

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ClinicalTrials.gov Identifier: NCT03050424
Recruitment Status : Unknown
Verified May 2017 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : February 10, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Ferric Carboxymaltose Drug: Sodium Chloride 0.9% Phase 2

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind, placebo-controlled, randomised trial
Primary Purpose: Treatment
Official Title: Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Ferric Carboxymaltose (FCM) (Ferinject) at 15 mg iron/kg body weight
Drug: Ferric Carboxymaltose
Ferric Carboxymaltose injectable Product
Other Name: Ferinject®

Placebo Comparator: Placebo
Sodium Chloride 0.9%
Drug: Sodium Chloride 0.9%
Sodium Chloride 0.9%




Primary Outcome Measures :
  1. Constant Rate Cycle Ergometry (75% Max Load) [ Time Frame: 8 weeks ]
    Increased exercise capacity as assessed by endurance cycle ergometry at 75% VO2max


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]
    COPD Assessment Test (CAT)

  2. Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]
    Medical Research Council (MRC) Dyspnoea Scale

  3. Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]
    Hospital Anxiety and Depression (HAD) Scale

  4. Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]
    Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  5. Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]
    EuroQoL Group (EQ-5D-5L)

  6. Muscle Oxygen Delivery [ Time Frame: Week 0; Week 8; Week 14 ]
    Near infrared spectroscopy during muscle contraction

  7. Endurance Shuttle Walk Test (ESWT) [ Time Frame: Week 0; Week 4; Week 10; Week 14 ]
    Change in endurance shuttle walk test distance and time

  8. Adverse Effects of Iron Administration [ Time Frame: Week 0; Week 4; Week 8; Week 10; Week 14 ]
    Any adverse effects of intravenous iron administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050424


Contacts
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Contact: Matthew Pavitt, MBBS, MRCP 0207 351 8029 M.Pavitt@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton & Harefield NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6HP
Contact: Matthew Pavitt, MBBS, MRCP         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Michael Polkey, MRCP, PhD Royal Bromtpon and Harefield NHS Foundation Trust

Additional Information:
Publications:

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03050424     History of Changes
Other Study ID Numbers: 2016LF003B
2016-000829-39 ( EudraCT Number )
16/EE/0355 ( Other Identifier: REC Reference )
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
COPD
Iron
Exercise Capacity
Non-anaemic iron deficiency

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics