The Effect of Acebrophylline vs Sustained Release Theophylline in Patients of COPD- A Comparative Study (original) (raw)

Effect of low-dose theophylline on airway inflammation in COPD

Respirology, 2004

Recent studies have shown that theophylline may exert anti-inflammatory effects on neutrophils. We undertook to assess the effect of theophylline on airway inflammation in COPD. We performed a 4-week randomized double-blind, placebo-controlled study in 11 theophylline-naive patients with mild to moderate COPD. After a 1-week run-in period, six subjects were administered 400 mg/day theophylline (Theodur; Nikken Chemicals Co. Ltd, Tokyo, Japan) for 4 weeks, while five subjects were administered a placebo. Induced sputum was obtained before and after the run-in period and then after 2 and 4 weeks of treatment. Cell differential count and levels of interleukin-8, matrix metalloproteinase-9, neutrophil elastase (NE), myeloperoxidase (MPO), alpha1-antitrypsin (alpha1-AT), leukotriene B4 and tissue inhibitor of metalloproteinases-1 (TIMP-1) were assessed. No variable was significantly different during the run-in period or with placebo treatment. In contrast, theophylline treatment significantly decreased NE and MPO levels at 4 weeks, although the cell differential count did not change appreciably as a result of treatment. These results suggest that 4 weeks of theophylline treatment attenuates neutrophil-associated inflammation in the airways of mild to moderate COPD patients. However, the clinical benefits remain to be determined.

Efficacy and Safety of Oral Low Dose Theophylline in Jordanian Patients with Stable Chronic Obstructive Pulmonary Disease Treated at King Hussein Medical Center

Journal of the Royal Medical Services, 2016

Objective: To assess the efficacy of adding Slow-Release Theophylline to the regular treatment of Chronic Obstructive Pulmonary Disease (COPD) patients. The safety of Theophylline was also assessed as a secondary endpoint. Methods: Prospective observational study of one hundred and nine patients, with moderate to very severe COPD, and treated in the pulmonology clinic at King Hussein Medical Center, between August 2014 and March 2015. Exclusion criteria included: acute exacerbation of COPD within the last 3 months; use of oral corticosteroids within the last 4 weeks; upper or lower respiratory tract infection within the last 4 weeks; recent unstable angina or arrhythmias; epilepsy; concurrent use of medications that might interact with Theophylline and excessive alcohol consumption. After enrolment, Forced Expiratory Volume in the first second (FEV1) and Forced Vital Capacity (FVC), oxygenation at rest using 2 different pulse oximeters and level of disability assessed by the Medical Research Council dyspnoea scale were evaluated. A fixed dose of oral Theophylline was added to their regular treatment, as Theophylline (Quibron-T SR) 300 mg slow-release capsules once daily. The patients were followed up after 4 weeks, when the measurements were repeated. The patients were also evaluated for any side effects related to Theophylline. The pre and post-Theophylline data were compared. The safety profile of Theophylline was assessed by recording side effects related to the drug, any serious side effects, or Theophylline withdrawal. Results: Out of the 109 patients in our study, 96(88%) were males, and 13(12%) were females. Their mean(±SD) age was 69.0±7.8 years(range 46-83 years). After 4 weeks of added Theophylline, there was a statistically significant improvement in FEV1 from 53.3±10.4 to 56.4±10.1 (% predicted mean±SD) (p= 0.03) and FVC from 70.4±10.0 to 73.1±9.8% (p= 0.05). 61% of the patients showed improvement in dyspnoea, with a significant improvement in the MRC score from 3.8±0.8 to 3.2±0.8 (p<0.0001). The patients also showed an increase in saturation from 93.6%±2.3 to 93.8%±2.0, though this was not statistically significant (p= 0.490). 5 patients (5%) had side effects related to Theophylline,though none were serious. The most common side effect was nausea (60%). None of the patients who developed side effects stopped using Theophylline during the study. Conclusion:Theophylline produced a significant increase in the lung function of patients with moderate, severe and very severe COPD and significantly improved their disability caused by dyspnoea, without any serious side effects. Use of Theophylline in stable COPD patients should be weighed however against the risk of possible non-serious side effects, mainly nausea.

A Prospective Survey on Safety of Sustained-Release Theophylline in Treatment of Asthma and COPD

Allergology International, 2006

Background: Theophylline is a useful drug for the treatment of asthma. The Asthma Prevention and Management Guidelines (JGL) recommend use of sustained-release theophylline products as controllers and of injectable aminophylline products as relievers. The Global Initiative for Asthma: Global Strategy for Asthma Management and Prevention, the NHLB! WHP Workshop Report 1995 (GINA, 1995) and guidelines in Western countries recommend sustained-release theophylline, but not as positively as in the JGL. The aim of this survey was to determine the occurrence of serious adverse reactions. Methods: The survey was conducted in 66 institutions staffed by physicians certified by the Japanese Society of Allergology (JSA). The target diseases were asthma and COPD including chronic bronchitis and pulmonary emphysema, which are indications for use of sustained-release theophylline products in Japan. Results: 3,921 patients were included in the safety evaluation. No serious adverse reactions were observed among the patients in this survey, although 54 patients (1.38%) exhibited non-serious adverse reactions. The incidence of adverse reactions was found to be high in patients who had begun use of sustained-release theophylline products at the time of registration in this survey , and in patients who were concomitantly taking macrolide antibiotics. Conclusions: The present survey demonstrates that sustained-release theophylline is safe, as long as used appropriately, although adverse reactions tend to develop early after initiation of administration.

Theophylline Therapy in Ambulatory Asthmatic Patients: Efficacy and Pharmacokinetics

Allergy and Asthma Proceedings, 1983

Theophylline has long been recognized as a potent bronchodilator. Pharmacodynamic and pharmacokinetic studies have greatly increased its efficacious use while decreasing the serious toxicity problems initially observed. Careful attention to recently established dosage guidelines can great~y minimize most untoward side effects.

Theophylline for Chronic Asthma: Rationale for Treatment, Product Selection, and Dosage Schedule

Allergy and Asthma Proceedings, 1983

Theophylline has emerged as one 0/ the mOST useful non-corticosteroid agents available for suppressing :rmptoms in the patient with chronic asthma. Maximal benefit, however, requires appreciation of the pharmacodynamics and pharmacokinetics o.l'This drug. A t concentrations between 10 and 20 mcg/ mi. optimal likelihood o.l benefit without toxiciTY is afTained and sympToms of asthma are virTualll' eliminated in many patients and are significant Zl' decreased even in paT ients requiring inhaled or oral COrTicosteroids. InrerpaTient variability in the rate ol drug elimination. however. resuiTs in a wide range o.l doses To atTain these serum concentrations. Initiation of therapy WiTh low doses and the determination o.ffinal dosage by measurement o.lserum theophylline concentration is essentialfor safe and eflective use. A simple and efficient dosing schedule has been developed that virtua/~l' eliminates problems of intolerance ol The drug and results in all buT about 1% o.l'children and almost as many adults ToleraTing theophylline without adverse effects. Sustained-release theophylline preparations, when relia-b~l' and complete~l' absorbed. o.ffer major therapeutic advantage by minimizing fluctuations in serum concen-Pro.

Slow-release theophylline for the management of chronic asthma

Singapore medical journal, 1985

In 1974 a report of a placebo-controlled double-blind crossover study indicated that treatment with theophylline was associated with a dramatic decrease in symptoms and signs of chronic asthma without adverse effects when used in individualized doses that maintained serum theophylline concentrations between 10 and 20 mcg/ml; doses of theophylline that approximated previous customary usage produced lower serum concentrations and were not effective in reducing symptoms (1). Although some bronchodilatory effect occurs at lower serum concentrations of theophylline (2), these and other datá (3) suggest that stabilization

The new trends in theophylline therapy

Bosnian journal of basic medical sciences / Udruzenje basicnih mediciniskih znanosti = Association of Basic Medical Sciences, 2002

Sustained-release theophylline pellets formulation for once-daily evening administration significantly improved patients compliance and adjusted serum levels profile of the drug. The patients conversion from i.v. to p.o. therapy is one of the most critical steps in the treatment of asthma according to its chronopathophysiological character. In our study we have examined safety and efficiency of this conversion in twelve hospitalised asthmatic patients who were given the new sustained-release theophylline pellets formulation for once-daily evening administration. The lung function parameters (FEV1, VC, RV, and Rt) and serum theophylline concentrations were monitored. So, the values obtained for the last day of i.v. therapy and the fifth day of p.o. therapy were compared. We found that 75% of the patients had no change or improved lung function on the conversion. Our results indicate that this conversion from i.v. to p.o. theophylline therapy is safe and could be efficacious. Also, th...

Use of Serum Theophylline Level as a Guide to Optimum Therapy in Patients with Chronic Obstructive Lung Disease

The Journal of Clinical Pharmacology, 1990

Blood and urine samples were collected simultaneously with measurements of pulmonary function at 2‐hour intervals for 8 hours after oral administration of short‐acting (SAT) and long‐acting theophylline (LAT) preparations in 15 patients with stable chronic obstructive lung disease (COLD) on long‐term maintenance theophylline therapy. The relationship between pulmonary function tests, serum theophylline level, plasma and urinary adenosine 3′5′ cyclic monophosphate (cAMP) was examined.The highest forced expiratory volume in one second FEV1 was obtained with STL of 12.8 μg/ml ± 5.21 SD and 9.14 μg/ml ± 6.15 (P <.05) after administration of SAT and LAT, respectively. A further increase in serum theophylline level (STL) offered no therapeutic benefit, and, in fact, was associated with a fall in FEV1 in many instances. Plasma or urinary cAMP measurements did not correlate with STL. STL at which the best pulmonary function is achieved is quite variable in patients with COLD on maintenan...