OBJECTIVE AND BACKGROUND: Increasing evidence suggests that low-dose theophylline has anti-inflammatory benefits and is safe in the treatment of COPD. This study aims to evaluate the efficacy and safety of low-dose, slow-release oral theophylline administered over a 1-year period in patients with COPD. METHODS: A randomized, double-blind, parallel-group, placebo-controlled trial was carried out. In total, 110 participants with COPD were randomly assigned to receive slow-release theophylline (100 mg b.i.d.) or placebo for 1 year. Use of medicine and symptoms recorded by diary cards; pulmonary function, exacerbations of COPD, quality of life and the use of rescue medicine were evaluated. Superiority test was used to estimate the efficacy. RESULTS:Of 110 participants, 85 (77.3%) complied with the protocol, with 42 subjects in theophylline and 43 subjects onplacebo. In both intention-to-treat and per-protocol population analysis, greater improvement in pre-bronchodilator FEV(1) (P = 0.038 and P = 0.070, respectively), lower frequency of COPD exacerbations (P = 0.047 and P = 0.035, respectively), fewer days of COPD exacerbations (P = 0.045 and P = 0.046, respectively), lower frequency of clinical visits (P = 0.017 and P = 0.039, respectively), greater improvement in satisfaction with treatment (P = 0.014 and P = 0.004, respectively) were found in the theophylline group than in the placebo group. In per-protocol population, greater improvements in quality of life (P = 0.047) were also observed in the theophylline group and the mean time to the first exacerbation was delayed in theophylline group in comparison with placebo group (P = 0.047). Drug-related adverse events such as stomach discomfort (3.51%), headache (3.51%), insomnia (1.75%) and palpitation (1.75%) were found in the theophylline group. CONCLUSIONS:Low-dose, slow-release oral theophylline is effective and well-tolerated in the long term treatment of stable COPD, although it does not improve post-bronchodilator lung function.
RCT Entities:
OBJECTIVE AND BACKGROUND: Increasing evidence suggests that low-dose theophylline has anti-inflammatory benefits and is safe in the treatment of COPD. This study aims to evaluate the efficacy and safety of low-dose, slow-release oral theophylline administered over a 1-year period in patients with COPD. METHODS: A randomized, double-blind, parallel-group, placebo-controlled trial was carried out. In total, 110 participants with COPD were randomly assigned to receive slow-release theophylline (100 mg b.i.d.) or placebo for 1 year. Use of medicine and symptoms recorded by diary cards; pulmonary function, exacerbations of COPD, quality of life and the use of rescue medicine were evaluated. Superiority test was used to estimate the efficacy. RESULTS: Of 110 participants, 85 (77.3%) complied with the protocol, with 42 subjects in theophylline and 43 subjects on placebo. In both intention-to-treat and per-protocol population analysis, greater improvement in pre-bronchodilator FEV(1) (P = 0.038 and P = 0.070, respectively), lower frequency of COPD exacerbations (P = 0.047 and P = 0.035, respectively), fewer days of COPD exacerbations (P = 0.045 and P = 0.046, respectively), lower frequency of clinical visits (P = 0.017 and P = 0.039, respectively), greater improvement in satisfaction with treatment (P = 0.014 and P = 0.004, respectively) were found in the theophylline group than in the placebo group. In per-protocol population, greater improvements in quality of life (P = 0.047) were also observed in the theophylline group and the mean time to the first exacerbation was delayed in theophylline group in comparison with placebo group (P = 0.047). Drug-related adverse events such as stomach discomfort (3.51%), headache (3.51%), insomnia (1.75%) and palpitation (1.75%) were found in the theophylline group. CONCLUSIONS: Low-dose, slow-release oral theophylline is effective and well-tolerated in the long term treatment of stable COPD, although it does not improve post-bronchodilator lung function.
Authors: Marc Miravitlles; Juan José Soler-Cataluña; Myriam Calle; Jesús Molina; Pere Almagro; José Antonio Quintano; Juan Antonio Riesco; Juan Antonio Trigueros; Pascual Piñera; Adolfo Simón; José Luis López-Campos; Joan B Soriano; Julio Ancochea Journal: Aten Primaria Date: 2012-06-15 Impact factor: 1.137
Authors: Graham Devereux; Seonaidh Cotton; Shona Fielding; Nicola McMeekin; Peter J Barnes; Andrew Briggs; Graham Burns; Rekha Chaudhuri; Henry Chrystyn; Lisa Davies; Anthony De Soyza; Simon Gompertz; John Haughney; Karen Innes; Joanna Kaniewska; Amanda Lee; Alyn Morice; John Norrie; Anita Sullivan; Andrew Wilson; David Price Journal: JAMA Date: 2018-10-16 Impact factor: 56.272
Authors: Gerard J Criner; Jean Bourbeau; Rebecca L Diekemper; Daniel R Ouellette; Donna Goodridge; Paul Hernandez; Kristen Curren; Meyer S Balter; Mohit Bhutani; Pat G Camp; Bartolome R Celli; Gail Dechman; Mark T Dransfield; Stanley B Fiel; Marilyn G Foreman; Nicola A Hanania; Belinda K Ireland; Nathaniel Marchetti; Darcy D Marciniuk; Richard A Mularski; Joseph Ornelas; Jeremy D Road; Michael K Stickland Journal: Chest Date: 2015-04 Impact factor: 9.410
Authors: Dheeraj Gupta; Ritesh Agarwal; Ashutosh Nath Aggarwal; V N Maturu; Sahajal Dhooria; K T Prasad; Inderpaul S Sehgal; Lakshmikant B Yenge; Aditya Jindal; Navneet Singh; A G Ghoshal; G C Khilnani; J K Samaria; S N Gaur; D Behera Journal: Lung India Date: 2013-07