Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Impact of Roflumilast on Visceral Adiposity and MetaBolic Profile in Chronic Obstructive Lung Disease: a Randomized and Controlled Trial: the RAMBO Trial.
The purpose of this study is to determine whether roflumilast can improve metabolic profile and reduce visceral adiposity in patients with chronic obstructive pulmonary disease (COPD).
Although underweight has been the traditional nutritional concern in patients with COPD,
overweight and obesity are becoming important issues in this disease. In a rehabilitation
study, investigators found that 66% of patients with moderate to severe COPD were either
overweight or obese according to the WHO obesity classification (BMI ≥ 25 kg/m2). Obesity
and COPD being two frequent conditions, it is important to understand the nature of their
interactions.
Obesity, particularly in its visceral form is associated with a plethora of metabolic
consequences that increases the risk of cardiovascular diseases. This would seem relevant to
COPD which is in itself an important risk factor for cardiovascular diseases. The presence
of obesity, particularly visceral obesity, may thus define in patients with COPD a clinical
phenotype at high risk of cardiovascular diseases. In this context, it is relevant to note
that the prevalence of metabolic syndrome is increased in COPD. Although fat distribution
has not been precisely assessed in COPD studies, increased waist circumference is common in
this disease suggesting that visceral obesity is part of the obesity syndrome seen in COPD.
Given the relationship between COPD, obesity and the metabolic syndrome and cardiovascular
diseases, it is tempting to suggest that visceral obesity is likely to be frequent in COPD
(as in the general population) and that the profound metabolic and inflammatory
perturbations associated with this form of overweight/obesity could play a central role in
the link between COPD and cardiovascular diseases.
Roflumilast, a Phosphodiesterase-4 inhibitor, has been recently evaluated as an
anti-inflammatory medication in patients with COPD. Roflumilast, alone or in combination
with long-acting bronchodilators, provide modest but significant improvement in lung
function along with reductions in the rate of exacerbation in patients with moderate to
severe COPD. A very interesting observation that was made in these 12-month duration studies
was that the use of roflumilast was associated with an average reduction in body weight of 2
kg that took place during the first 6 months of the trials and remained relatively stable
throughout the rest of the trials. The mechanisms and the precise effects of roflumilast on
body composition and adipose tissue distribution have not been studied in great detail.
However, available data suggest that roflumilast induces a preferential loss in body fat
mass in comparison to fat-free mass. It remains to be seen whether roflumilast specifically
affects visceral versus subcutaneous adipose tissue. The improved insulin sensitivity
reported in one study in the presence of an apparently trivial weight loss (0.7 kg compared
to placebo) may suggest that a selective loss of visceral adipose tissue may have been
produced in response to roflumilast therapy.
These observations, although not definitive, suggest that roflumilast could be used not only
to treat the respiratory component of COPD but also to modulate the metabolic aspect of this
disease including visceral adiposity, features of the metabolic syndrome and significant
co-morbidities of COPD.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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