Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05699720 |
| Other study ID # |
7372/REG/KEMU2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
January 2023 |
| Source |
King Edward Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is designed to determine the effect of Nebulized Magnesium Sulphate as an add-on
therapy with conventional treatment on In-hospital outcome in patients having acute
exacerbation of COPD.
Description:
Chronic obstructive pulmonary disease (COPD) is called as the second highly common
respiratory disorder after pulmonary Tuberculosis in Pakistan. It is characterized by chronic
and progressive breathlessness, cough, sputum production and airflow obstruction, which
progressively lead to restricted activity and impaired life quality (1). According to the
World Health Organization, COPD would be the third leading cause of mortality by 2020. It
imposes a significant economic burden on account of its morbidity (2). This chronic
debilitating disorder is accompanied by various comorbid factors that contribute to a spiral
of decline, leading to an increase in mortality (3). Episodes of acute deterioration
associated with COPD is called exacerbations. These exacerbations are among one of the most
common causes of hospital admissions in the country. Acute exacerbation is triggered by
bacterial and viral infections and can also be precipitated by environmental factors,
including air pollution, second-hand smoke, and periodically variations, i.e., low
temperature (winter season) (1). Acute exacerbation lead to deterioration in the patients'
quality of life, adverse effects on symptoms and lung functions that may last for many weeks,
reduction in lung functions, frequent hospital visits, increase in health expenditure, and
significant mortality as lung function cannot recover entirely afterwards (1,2). Acute
exacerbations of COPD are treated by oxygen, inhaled bronchodilators, i.e., beta-2 agonists
and anticholinergics, antibiotics, and steroids (2,3).
Exacerbations, during the illness, drastically affect the quality of life of the patient, put
a burden on healthcare expenses, and are associated with an increase in mortality.
Exacerbations also result in the worsening of airway obstruction and an increase in the
inflammatory response (5). While smoking is said to be the most significant risk factor in
the etiology of COPD, infections mainly account for recurrent episodes of exacerbation
occurring during this illness. With advancing industrialization, environmental factors in the
form of increasing air pollution contribute to COPD exacerbation pathogenesis (1,2).
Effective management of acute exacerbations of COPD will slow disease progression, improve
the patient's health status, and lessen the burden on healthcare services (5). It increases
interest in optimizing COPD treatment and devising new modalities to prevent episodes of
exacerbations. Pulmonary rehabilitation, oxygen inhalation, inhaled and systemic
corticosteroids, bronchodilators (β2-agonists and anticholinergic agents), and, if required,
mechanical ventilation constitute the standard treatment regimen in COPD. There is a
compelling interest in devising increased new strategies to effectively manage and decrease
the severity and frequency of exacerbations (4).
Magnesium is a Calcium-mediated bronchodilator that acts with different mechanisms such as
calcium antagonism via Calcium-Channels and counteraction of Calcium-medicated smooth muscle
contraction, inhibiting the release of Histamine and Acetylcholine from mast cells and
cholinergic nerve endings, respectively (2). It is proven that Magnesium helps in providing
enhanced bronchodilator effect in acute exacerbations of asthma. However, fewer data and
conflicting results are seen regarding its use in acute aggravation of COPD. So far, only six
studies have investigated the bronchodilator efficacy of magnesium sulphate in COPD.
Intravenous administration of Magnesium during exacerbations of chronic obstructive pulmonary
disease (COPD) resulted in the improvement of peak flow.
Randomized, single-blinded, placebo-controlled trials showed that intravenous magnesium
sulphate (MgSO4), when given as an adjunct to standard therapy in severe acute asthma, causes
pulmonary function improvement and decreases in-hospital admissions (4). Nebulized MgSO4,
either separately or in combination with salbutamol, has a visible bronchodilator impact in
severe asthma and shows proven betterment (5).
Acute intravenous magnesium in stable COPD patients resulted in a decline of lung
hyperinflation as well as improved respiratory muscle strength (5). There are very few
placebo-based clinical trials evaluating the efficacy of magnesium sulphate administered via
intravenous, nebulized, or both routes in COPD exacerbations. One such trial showed that
Intravenous administration of magnesium sulphate has no bronchodilating effect in patients
with COPD exacerbations. However, it enhances the bronchodilating effect of other inhaled
short-acting bronchodilators (6). Nebulized magnesium sulphate, when added to standard
bronchodilator treatment, provides additional relief of dyspnea in patients of acute
exacerbations (2). However, these studies showed inconclusive results, and the clinical
potential of Magnesium deserves to be further investigated.
Nebulized magnesium sulphate may show promising bronchodilator effect as an add-on therapy to
the conventional treatment for COPD exacerbations due to its intracellular effects. In case
of a positive outcome, this practice can be incorporated in the management of COPD in its
acute exacerbations because of its low cost, being readily available in our hospital
settings, convenient mode of administration, and lesser side effects.
