Phase 3 randomized study of the efficacy and safety of inhaled dry powder mannitol for the symptomatic treatment of non-cystic fibrosis bronchiectasis

Chest

Volumn 144, Issue 1, 2013, Pages 215-225

  Bilton, Diana ^a   Daviskas, Evangelia ^b   Anderson, Sandra D ^b   Kolbe, John ^f   King, Gregory ^c   Stirling, Rob G ^e   Thompson, Bruce R ^f   Milne, David ^g   Charlton, Brett ^d  

^a ROYAL BROMPTON HOSPITAL   (United Kingdom)

^b ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^c ROYAL NORTH SHORE HOSPITAL   (Australia)

^d Medical Department   (Australia)

^e ALFRED HOSPITAL   (Australia)

^f UNIVERSITY OF AUCKLAND   (New Zealand)

^g AUCKLAND DISTRICT HEALTH BOARD   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; MANNITOL; PLACEBO;

ADOLESCENT; ADULT; AGED; ARTICLE; BRONCHIECTASIS; BRONCHOSPASM; BRONCHUS MUCUS; CONTROLLED STUDY; COUGHING; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY POWDER; DYSPNEA; EPISTAXIS; FEMALE; FORCED EXPIRATORY VOLUME; HEADACHE; HEMOPTYSIS; HIGH RESOLUTION COMPUTER TOMOGRAPHY; HUMAN; LARYNX PAIN; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; OPEN STUDY; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PREDICTION; PRIORITY JOURNAL; PROVOCATION TEST; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SORE THROAT; SPUTUM ANALYSIS; SPUTUM VISCOSITY; ST. GEORGE RESPIRATORY QUESTIONNAIRE; THORAX PAIN; THROAT IRRITATION; TREATMENT DURATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION;

EID: 84880078608     PISSN: 00123692     EISSN: 19313543     Source Type: Journal    
DOI: 10.1378/chest.12-1763     Document Type: Article

References (33)

1. Goeminne P, Dupont L. Non-cystic fibrosis bronchiectasis: diagnosis and management in 21st century. Postgrad Med J. 2010; 86 (1018): 493-501.
2. Steinfort DP, Brady S, Weisinger HS, Einsiedel L. Bronchiectasis in Central Australia: a young face to an old disease. Respir Med. 2008; 102 (4): 574-578.
3. Twiss J, Metcalfe R, Edwards E, Byrnes C. New Zealand national incidence of bronchiectasis "too high" for a developed country. Arch Dis Child. 2005; 90 (7): 737-740.
4. Chang AB, Masel JP, Boyce NC, Wheaton G, Torzillo PJ. Non-CF bronchiectasis: clinical and HRCT evaluation. Pediatr Pulmonol. 2003; 35 (6): 477-483.
5. Weycker D, Edelsberg J, Oster G, Tino G. Prevalence and economic burden of bronchiectasis. Clin Pulm Med. 2005; 12 (4): 205-209.
6. Chang AB, Bell SC, Byrnes CA, et al. Chronic suppurative lung disease and bronchiectasis in children and adults in Australia and New Zealand. Med J Aust. 2010; 193 (6): 356-365.
7. Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010; 65 (suppl 1): i1-i58.
8. Bye PT, Lau EMT, Elkins MR. Pharmacological airway clearance strategies in bronchiectasis. European Respiratory Monograph. 2011; 52: 239-247.
9. Daviskas E, Anderson SD, Gomes K, et al. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005; 10 (1): 46-56.
10. Bilton D, Robinson P, Cooper P, et al; CF301 Study Investigators. Inhaled dry powder mannitol in cystic fibrosis: an efficacy and safety study. Eur Respir J. 2011; 38( 5): 1071-1080.
11. Aitken ML, Bellon G, De Boeck K, et al. Long-term inhaled mannitol in cystic fibrosis: an international randomized study. Am J Resp Crit Care Med. 2012; 185 (6): 645-652.
12. Daviskas E, Turton JA, Anderson SD, Young IH, Lassig A, Charlton B. A placebo controlled trial with inhaled mannitol improves health related quality of life in patients with bronchiectasis. Eur Respir J. 2004; 24 (suppl 48): 707.
13. Nicolson CH, Stirling RG, Borg BM, Button BM, Wilson JW, Holland AE. The long term effect of inhaled hypertonic saline 6% in non-cystic fibrosis bronchiectasis. Respir Med. 2012; 106 (5): 661-667.
14. Kellett F, Robert NM. Nebulised 7% hypertonic saline improves lung function and quality of life in bronchiectasis. Respir Med. 2011; 105 (12): 1831-1835.
15. Elkins MR, Robinson M, Rose BR, et al; National Hypertonic Saline in Cystic Fibrosis (NHSCF) Study Group. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006; 354 (3): 229-240.
16. Daviskas E, Anderson SD, Eberl S, Chan H-K, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999; 159 (6): 1843-1848.
17. Daviskas E, Anderson SD, Young IH. Effect of mannitol and repetitive coughing on the sputum properties in bronchiectasis. Respir Med. 2010; 104 (3): 371-377.
18. Daviskas E, Anderson SD, Eberl S, Chan H-K, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001; 119 (2): 414-421.
19. Robinson M, Daviskas E, Eberl S, et al. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. Eur Respir J. 1999; 14 (3): 678-685.
20. Daviskas E, Anderson SD, Young IH. Inhaled mannitol changes the sputum properties in asthmatics with mucus hypersecretion. Respirology. 2007; 12 (5): 683-691.
21. Goldman MD, Daviskas E, Turton JA, Anderson SD. Inhaled mannitol improves lung function assessed by forced oscillation in a placebo-controlled trial in patients with bronchiectasis [abstract]. Eur Resp J. 2004 ;24( suppl 48): 470s-471s.
22. Brannan JD, Anderson SD, Perry CP, Freed-Martens R, Lassig AR, Charlton B; Aridol Study Group. The safety and efficacy of inhaled dry powder mannitol as a bronchial provocation test for airway hyperresponsiveness: a phase 3 comparison study with hypertonic (4.5%) saline. Respir Res. 2005; 6: 144.
23. Patterson JE, Hewitt O, Kent L, Bradbury I, Elborn JS, Bradley JM. Acapella versus 'usual airway clearance' during acute exacerbation in bronchiectasis: a randomized crossover trial. Chron Respir Dis. 2007; 4 (2): 67-74.
24. Miller MR, Hankinson J, Brusasco V, et al; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005; 26 (2): 319-338.
25. Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault J-C. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung FunctionTests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J. 1993; 6 (suppl 16): 5-40.
26. Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991; 85 (suppl B): 25-31.
27. Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MDL, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003; 58 (4): 339-343.
28. Fuchs HJ, Borowitz DS, Christiansen DH, et al; The Pulmozyme Study Group. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N Engl J Med. 1994; 331 (10): 637-642.
29. Roberts HR, Wells AU, Milne DG, et al. Airflow obstruction in bronchiectasis: correlation between computed tomography features and pulmonary function tests. Thorax. 2000; 55 (3): 198-204.
30. King GG, Müller NL, Whittall KP, Xiang QS, Paré PD. An analysis algorithm for measuring airway lumen and wall areas from high-resolution computed tomographic data. Am J Respir Crit Care Med. 2000; 161 (2 pt 1): 574-580.
31. Singh SJ, Morgan MDL, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992; 47( 12): 1019-1024.
32. Jones PWSt. George's Respiratory Questionnaire: MCID COPD. J of Chronic Obst Pulm Dis. 2005; 2 (1): 75-79.
33. Wills PJ. Inhaled mannitol in cystic fibrosis. Expert Opin Investig Drugs. 2007; 16 (7): 1121-1126.