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British Journal of Medicine and Medical Research, ISSN: 2231-0614,Vol.: 6, Issue.: 11


An Acute Therapeutic Evaluation of Three Regimens of Tiotropium and Formoterol in COPD Patients: A Randomized, Double-blind, Placebo-Controlled Clinical Study


Mohammed Imran1*, Sunil Kumar Chhabra2 and Anita Kotwani3

1Department of Pharmacology, Shaheed Hasan Khan Mewati Government Medical College, Nalhar, Nuh, Mewat, Haryana, India.
2Department of Cardiorespiratory Physiology, Vallabhbhai Patel Chest Institute and Vishwanathan Chest Hospital, University of Delhi, Delhi, India.
3Department of Pharmacology, Vallabhbhai Patel Chest Institute and Vishwanathan Chest Hospital, University of Delhi, Delhi, India.

Article Information
(1) Oswin Grollmuss, Department of Pediatric and Adult Resuscitation Congenital Heart of Centre Chirurgical Marie Lannelongue, University Paris XI, France.
(1) Anonymous, Japan.
(2) Anonymous, Spain.
(3) Anonymous, Italy.
Complete Peer review History: http://www.sciencedomain.org/review-history/7917


Aims: To evaluate therapeutic rationality of combining long-acting β2-agonists (formoterol) with duration of action of 12 hours and anticholinergics (tiotropium) with 24 hours as fixed dose inhaled combination (FDC) still widely prescribed in developing countries in COPD patients.
Study Design: A randomized, double-blind, placebo-controlled, parallel design study. The three regimens that were used; tiotropium 18 µg once a day in the morning along with the formoterol matched placebo in the evening, the FDC of tiotropium 18 µg plus formoterol 12 µg once a day in the morning and formoterol matched placebo in the evening and the same FDC of the two drugs once a day in the morning and once a day formoterol 12 µg in the evening in patients of COPD without any co-morbidity.
Place and Duration of Study: Tertiary care pulmonary medicine university teaching government hospital of Delhi, India; 1 year.
Methodology: Sixty COPD patients (Male, Avg. age 56±11 years) divided into 3 groups of 20 each without any comorbidity were admitted in the hospital for 24 hours. The spirometry, perception of dyspnea on Borg's scale and vitals such as blood pressure (BP) and pulse rate (PR) were recorded at the following interval 30 minutes, 2 hours, 12 hours after the morning dose and 30 minutes and 12 hours after the evening dose.
Results: Addition of formoterol in the evening along with the FDC in the morning enhanced the peak effects in percentage predicted FEV1 (82.55+/-12.639), FEV1/FVC (0.592±0.097) that remained till the next dose (24 hours) which was statistically (P=.05) superior to the tiotropium alone group (75.55+/-17.981) as well as FDC alone group (74.55+/-12.655).
Conclusion: There is no advantage of FDC once a day over tiotropium alone. However addition of evening dose of formoterol has shown therapeutic superiority over once a day FDC of the two in COPD.

Keywords :

Chronic Obstructive Pulmonary Disease (COPD); Fixed Dose Combinations (FDCs); long acting-muscarinic antagonists (LAMA); long acting β2 agonists (LABA); tiotropium, formoterol.

Full Article - PDF    Page 1069-1077

DOI : 10.9734/BJMMR/2015/14053

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