Methacholine challenge tests to demonstrate therapeutic equivalence of terbutaline sulfate via different Turbuhaler ® devices in patients with mild to moderate asthma: Appraisal of a four-way crossover design

Author:

Bjermer Leif,Gauvreau Gail M.,Postma Dirkje S.,O'Byrne Paul M.,van den Berge Maarten,Boulet Louis-Philippe,Beckman Ola,Persson Tore,Román JonasORCID,Carlholm Marie,Schützer Kajs-MarieORCID,Eckerwall Göran

Publisher

Elsevier BV

Subject

Pharmacology (medical),Biochemistry, medical,Pulmonary and Respiratory Medicine

Reference13 articles.

1. Therapeutic equivalence of Spiros dry powder inhaler and Ventolin metered dose inhaler. A bioassay using methacholine;Ahrens;Am. J. Respir. Crit. Care Med.,1999

2. Bronchial responsiveness to inhaled histamine and exercise;Anderton;J. Allergy Clin. Immunol.,1979

3. Bronchial reactivity to inhaled histamine: a method and clinical survey;Cockcroft;Clin. Allergy,1977

4. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents. London: European Medicines Agency. CHMP; 22 January 2009.. Doc Ref. CPMP/EWP/4151/00 Rev1. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003504.pdf.

5. Dose equivalence and bronchoprotective effects of salmeterol and salbutamol in asthma;Higham;Thorax,1998

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