A randomized, double-blind, double-dummy, single-dose, crossover trial evaluating the efficacy and safety profiles of two dose levels (12 and 24 μg) of formoterol-HFA (pMDI) vs. those of a dose level (24 μg) of formoterol-DPI (Foradil®/Aerolizer™) and of placebo (pMDI or Aerolizer) in moderate to severe asthmatic patients

Respiration

Volumn 72, Issue SUPPL. 1, 2005, Pages 13-19

  Bousquet, J ^a   Guenole E ^b   Duvauchelle, T ^c   Vicaut, E ^d   Lefrancois G ^e  

^a HÔPITAL ARNAUD DE VILLENEUVE   (France)

^b Therapharm Recherches   (France)

^c Aster Cephac   (France)

^d HÔPITAL LARIBOISIÈRE   (France)

^e Chiesi   (France)

Author keywords

Asthma; Clinical equivalence; Dry powder inhalers; Formoterol; Hydrofluoroalkanes; Pressurized metered dose inhalers

Indexed keywords

FORMOTEROL; NORFLURANE; PLACEBO;

ADULT; AGED; ANXIETY; ARTICLE; ASTHENIA; ASTHMA; BRONCHODILATING ACTIVITY; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DIARRHEA; DISEASE EXACERBATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DYSPNEA; FEMALE; FORCED EXPIRATORY VOLUME; GASTROENTERITIS; HEADACHE; HEART PALPITATION; HUMAN; HYPOKALEMIA; LUNG DISEASE; LUNG FUNCTION TEST; MAJOR CLINICAL STUDY; MALE; MEDICAL ASSESSMENT; METERED DOSE INHALER; MODERATE PERSISTENT ASTHMA; MULTICENTER STUDY; NAUSEA; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; SAMPLE SIZE; SEVERE PERSISTENT ASTHMA; SIDE EFFECT; SINGLE DRUG DOSE; SYNCOPE; TREMOR; VOMITING;

ADULT; AEROSOL PROPELLANTS; AEROSOLS; ASTHMA; BRONCHODILATOR AGENTS; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; ETHANOLAMINES; FEMALE; HUMANS; HYDROCARBONS, FLUORINATED; MALE; METERED DOSE INHALERS; MIDDLE AGED; POWDERS; SEVERITY OF ILLNESS INDEX; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 20944445483     PISSN: 00257931     EISSN: None     Source Type: Journal    
DOI: 10.1159/000083688     Document Type: Article

References (14)

1. Montreal Protocol [Accessed 2002, Apr 19] on line. Available from: http://www.unep.org/ozone/pdf/Montreal-Protocol2000.pdf.
2. Forte R Jr, Dibble C: The role of international environmental agreements in metered-dose inhaler technology changes. J Allergy Clin Immunol 1999;104:S217-S220.
3. Global Initiative for Asthma: Global strategy for asthma management and prevention. National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) 2002, pp 1-192.
4. Palmqvist M, Persson G, Lazer L, Rosenborg J, Larsson P, Lotvall J: Inhaled dry-powder formoterol and salmeterol in asthmatic patients: Onset of action, duration of effect and potency. Eur Respir J 1997;10:2484-2489.
5. Steinijans VW, Neuhauser M, Hummel T, Leichtl S, Rathgeb F, Keller A: Asthma management: The challenge of equivalence. Int J Clin Pharmacol Ther 1998;36:117-125.
6. Bartow RA, Brogden RN: Formoterol. An update of its pharmacological properties and therapeutic efficacy in the management of asthma. Drugs 1998;55:303-322.
7. Ganderton D, Lewis D, Davies R, Meakin B, Brambilla G, Church T: Modulite: A means of designing the aerosols generated by pressurized metered dose inhalers. Respir Med 2002;96:S3-S8.
8. Bousquet J: Introduction. Modulite: Simplifying the changeover. Respir Med 2002;96:S1-S2.
9. Magnussen H: Budesonide Modulite: Improving the changeover to CFC-free treatments. Respir Med 2003;97:S1-S3.
10. Bousquet J, Cantini L: Clinical studies in asthmatics with a new non-extra fine HFA formulation of beclometasone dipropionate (BDP Modulite). Respir Med 2002;96:S17-S27.
11. Anderson PB, Langley SJ, Mooney P, Jones J, Addlestone R, Rossetti A, Cantini L: Equivalent efficacy and safety of a new HFA-134a formulation of BDP compared with the conventional CFC in adult asthmatics. J Investig Allergol Clin Immunol 2002;12:107-113.
12. Grzelewska-Rzymowska I, Malolepszy J, de Molina M, Sladek K, Zarkovice J, Siergiejko Z: Equivalent asthma control and systemic safety of inhaled budesonide delivered via HFA-134a or CFC propellant in a broad range of doses. Respir Med 2003;97:S10-S19.
13. Vastagh E, Kuna P, Calistruc P, Bogdan MA: Efficacy and safety of inhaled budesonide delivered once or twice daily via HFA-134a in mild to moderate persistent asthma in adult patients. Comparison with budesonide CFC. Respir Med 2003;97:S20-S28.
14. Sears MR: Adverse effects of beta-agonists. J Allergy Clin Immunol 2002;110:8322-8328.