A new class of bronchodilator improves lung function in COPD: A trial with GSK961081

European Respiratory Journal

Volumn 42, Issue 4, 2013, Pages 972-981

  Wielders, Pascal L M L ^a   Ludwig Sengpiel, Andrea ^b   Locantore, Nicholas ^c   Baggen, Suus ^d   Chan, Robert ^e   Riley, John H ^e  

^a CATHARINA HOSPITAL   (Netherlands)

^b KLB Healthresearch Luebeck   (Germany)

^c GLAXOSMITHKLINE   (United States)

^d GLAXOSMITHKLINE   (Netherlands)

^e GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BRONCHODILATING AGENT; GLUCOSE; GSK 961081; PLACEBO; POTASSIUM; SALMETEROL; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BACKACHE; BLOOD PRESSURE; BRONCHODILATING ACTIVITY; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONTROLLED STUDY; COUGHING; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPHONIA; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HEART PALPITATION; HEART RATE; HUMAN; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCLE SPASM; MYALGIA; NAUSEA; PARALLEL DESIGN; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SPIROMETRY;

AGED; ALBUTEROL; BRONCHODILATOR AGENTS; CARBAMATES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; FORCED EXPIRATORY VOLUME; HUMANS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PATIENT SAFETY; PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; QUINOLONES; SMOKING; SPIROMETRY; TREATMENT OUTCOME;

EID: 84886517217     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/09031936.00165712     Document Type: Article

References (21)

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD, 2011. www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html Date last accessed: October 10, 2012. Date last updated: February 2013.
2. Celli BR, MacNee W, ATS/ERS Task Force. Standards of the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J 2004; 23: 932-946.
3. Cazzola M, Molimard M. The scientific rationale for combining long-acting b2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther 2010; 23: 257-267.
4. Cazzola M, Centanni S, Santus P, et al. The functional impact of adding salmeterol and tiotropium in patients with stable COPD. Respir Med 2004; 98: 1214-1221.
5. Cazzola M, Noschese P, Salzillo A, et al. Bronchodilator response to formoterol after regular tiotropium or to tiotropium after regular formoterol in COPD patients. Respir Med 2005; 99: 524-528.
6. van Noord JA, Aumann JL, Janssens E, et al. Comparison of tiotropium once daily, formoterol twice daily and both combined once daily in patients with COPD. Eur Respir J 2005; 26: 214-222.
7. van Noord JA, Aumann JL, Janssens E, et al. Effects of tiotropium with and without formoterol on airflow obstruction and resting hyperinflation in patients with COPD. Chest 2006; 129: 509-517.
8. Tashkin DP, Littner M, Andrews CP, et al. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med 2008; 102: 479-487.
9. van der Molen T, Cazzola M. Beyond lung function in COPD management: effectiveness of LABA/LAMA combination therapy on patient-centred outcomes. Prim Care Respir J 2012; 21: 101-108.
10. Aaron SD, Vandemheen KL, Fergusson D, et al. Tiotropium in combination with placebo, salmeterol, or fluticasone-salmeterol for treatment of chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med 2007; 146: 545-555.
11. Jacobsen JR, Aiyar J, Hegde S, et al. Dual-pharmacology bronchodilators for the treatment of COPD. In: M. Hansel TT, Barnes PJ, eds. New Drugs and Targets for Asthma and COPD. Progress in Respiratory Research. Vol. 39. Basel, Karger, 2010; pp. 39-45.
12. Aiyar J, Steinfeld T, Pulido-Rios MT, et al. In vitro characterization of TD-5959: a novel bi-functional molecule with muscarinic antagonist and b2-adrenergic agonist activity. Am J Respir Crit Care Med 2009; 179: A4552.
13. Pulido-Rios MT, McNamara A, Kwan K, et al. TD-5959: a novel bi-functional muscarinic antagonist-b2-adrenergic agonist with potent and sustained in vivo bronchodilator activity in guinea pigs. Am J Respir Crit Care Med 2009; 179: A6195.
14. GSK Clinical Trials Register A study to investigate the relative pharmacological activity of an inhaled b2-agonist/ anticholinergic dual pharmacophore in healthy volunteers. www.gsk-clinicalstudyregister.com/quick- search-list. jsp?item5MAB110553&type5GSK+Study+ID&studyId5MAB110553 Date last updated: April 21, 2009.
15. Norris V, Zhu C, Ambery C. The pharmacodynamics of GSK961081 in patients with COPD. Eur Respir J 2011; 38: Suppl. 55, 138s.
16. Centers for Disease Control and Prevention. National Health and Nutrition Examination Survey III. www.cdc.gov/ nchs/nhanes/nh3data.htm Date last accessed: October 10, 2012.
17. Donohue JF. Minimal clinically important differences in COPD lung function. COPD 2005; 2: 111-124.
18. Donohue JF, van Noord JA, Bateman ED, et al. A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol. Chest 2002; 122: 47-55.
19. Buhl R, Dunn LJ, Disdier C, et al. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD. Eur Respir J 2011; 38: 797-803.
20. Bateman E, Ferguson GT, Barnes N, et al. Benefits of dual bronchodilation with QVA149 once daily versus placebo, indacaterol, NVA237 and tiotropium in patients with COPD: the SHINE study. Eur Respir J 2012; 40: Suppl. 56, 509s.
21. Mahler DA, D'Urzo A, Bateman E, et al. Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomised, double-blind comparison. Thorax 2012; 67: 781-788.