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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Ferric Carboxymaltose

Sodium Chloride 0.9%

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Iron, Exercise Capacity, Non-anaemic iron deficiency

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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
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.

Exclusion Criteria:

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):
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.

Sites / Locations

Royal Brompton & Harefield NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

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

Sodium Chloride 0.9%

Outcomes

Primary Outcome Measures

Constant Rate Cycle Ergometry (75% Max Load)

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

Secondary Outcome Measures

Quality of Life

COPD Assessment Test (CAT)

Quality of Life

Medical Research Council (MRC) Dyspnoea Scale

Quality of Life

Hospital Anxiety and Depression (HAD) Scale

Quality of Life

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

Quality of Life

EuroQoL Group (EQ-5D-5L)

Muscle Oxygen Delivery

Near infrared spectroscopy during muscle contraction

Endurance Shuttle Walk Test (ESWT)

Change in endurance shuttle walk test distance and time

Adverse Effects of Iron Administration

Any adverse effects of intravenous iron administration

Full Information

NCT ID

NCT03050424

First Posted

February 7, 2017

Last Updated

May 11, 2017

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03050424

Brief Title

Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial

Acronym

ICE-T

Official Title

Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

October 1, 2018 (Anticipated)

Study Completion Date

January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Iron, Exercise Capacity, Non-anaemic iron deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double blind, placebo-controlled, randomised trial

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Sodium Chloride 0.9%

Intervention Type

Drug

Intervention Name(s)

Ferric Carboxymaltose

Other Intervention Name(s)

Ferinject®

Intervention Description

Ferric Carboxymaltose injectable Product

Intervention Type

Drug

Intervention Name(s)

Sodium Chloride 0.9%

Intervention Description

Sodium Chloride 0.9%

Primary Outcome Measure Information:

Title

Constant Rate Cycle Ergometry (75% Max Load)

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Quality of Life

Description

COPD Assessment Test (CAT)

Time Frame