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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Ferric Carboxymaltose Drug: Sodium Chloride 0.9%||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind, placebo-controlled, randomised trial|
|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|
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%
- Constant Rate Cycle Ergometry (75% Max Load) [ Time Frame: 8 weeks ]Increased exercise capacity as assessed by endurance cycle ergometry at 75% VO2max
- Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]COPD Assessment Test (CAT)
- Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]Medical Research Council (MRC) Dyspnoea Scale
- Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]Hospital Anxiety and Depression (HAD) Scale
- Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
- Quality of Life [ Time Frame: Week 0; Week 8; Week 10; Week 14 ]EuroQoL Group (EQ-5D-5L)
- Muscle Oxygen Delivery [ Time Frame: Week 0; Week 8; Week 14 ]Near infrared spectroscopy during muscle contraction
- Endurance Shuttle Walk Test (ESWT) [ Time Frame: Week 0; Week 4; Week 10; Week 14 ]Change in endurance shuttle walk test distance and time
- Adverse Effects of Iron Administration [ Time Frame: Week 0; Week 4; Week 8; Week 10; Week 14 ]Any adverse effects of intravenous iron administration
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
|Contact: Matthew Pavitt, MBBS, MRCP||0207 351 8029||M.Pavitt@rbht.nhs.uk|
|Royal Brompton & Harefield NHS Foundation Trust||Recruiting|
|London, United Kingdom, SW3 6HP|
|Contact: Matthew Pavitt, MBBS, MRCP|
|Principal Investigator:||Michael Polkey, MRCP, PhD||Royal Bromtpon and Harefield NHS Foundation Trust|