BIOMAT Database Logo BIOMAT Database Logo

A double-blind, placebo-controlled steroid-sparing study with budesonide Turbuhaler in Japanese oral steroid-dependent asthma patients. Japanese Pulmicort Turbuhaler study group. 2000

T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
National Sagamihara Hospital, Japan.

OBJECTIVE The aim of this study was to evaluate the oral steroid-sparing capacity of budesonide Turbuhaler. METHODS One hundred and thirteen oral steroid-dependent patients were treated for 6 months with placebo or budesonide 800 microg or 1600 microg daily. Every second week the oral steroid dose was reduced if asthma control permitted. RESULTS The reductions in oral steroid doses were 9, 35 and 60% in the placebo and budesonide 800 microg and 1600 microg groups, respectively. Oral steroid treatment could be discontinued in 4% (placebo), 15% (800 microg) and 23% (1600 microg). Mean peak expiratory flow values increased by 21 and 24 L/min in the budesonide groups but decreased by 6 L/min in the placebo group. Asthma attack, activity and sleep scores remained unchanged showing maintained efficacy. Plasma cortisol levels increased and an adrenocorticotropic hormone test showed improved adrenocortical response in both budesonide groups, indicating improved safety. Adverse drug reactions were infrequent and mild in all study groups. CONCLUSIONS Budesonide Turbuhaler, 800 microg and 1600 microg daily, resulted in a significant reduction in oral steroid usage in steroid-dependent patients. The effect was achieved with maintained asthma control together with improvements in lung and adrenal functions.

UI MeSH Term Description Entries
D007564 Japan A country in eastern Asia, island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. The capital is Tokyo. Bonin Islands
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009330 Nebulizers and Vaporizers Devices that cause a liquid or solid to be converted into an aerosol (spray) or a vapor. It is used in drug administration by inhalation, humidification of ambient air, and in certain analytical instruments. Atomizers,Inhalation Devices,Inhalators,Inhalers,Vaporizers,Nebulizers,Vaporizers and Nebulizers,Atomizer,Device, Inhalation,Devices, Inhalation,Inhalation Device,Inhalator,Inhaler,Nebulizer,Vaporizer
D010366 Peak Expiratory Flow Rate Measurement of the maximum rate of airflow attained during a FORCED VITAL CAPACITY determination. Common abbreviations are PEFR and PFR. Expiratory Peak Flow Rate,Flow Rate, Peak Expiratory,PEFR
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D011239 Prednisolone A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states. Di-Adreson-F,Predate,Predonine,Di Adreson F,DiAdresonF
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D001993 Bronchodilator Agents Agents that cause an increase in the expansion of a bronchus or bronchial tubes. Bronchial-Dilating Agents,Bronchodilator,Bronchodilator Agent,Broncholytic Agent,Bronchodilator Effect,Bronchodilator Effects,Bronchodilators,Broncholytic Agents,Broncholytic Effect,Broncholytic Effects,Agent, Bronchodilator,Agent, Broncholytic,Agents, Bronchial-Dilating,Agents, Bronchodilator,Agents, Broncholytic,Bronchial Dilating Agents,Effect, Bronchodilator,Effect, Broncholytic,Effects, Bronchodilator,Effects, Broncholytic
D003627 Data Interpretation, Statistical Application of statistical procedures to analyze specific observed or assumed facts from a particular study. Data Analysis, Statistical,Data Interpretations, Statistical,Interpretation, Statistical Data,Statistical Data Analysis,Statistical Data Interpretation,Analyses, Statistical Data,Analysis, Statistical Data,Data Analyses, Statistical,Interpretations, Statistical Data,Statistical Data Analyses,Statistical Data Interpretations

Related Publications

T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
Oral glucocorticosteroid-sparing effect of budesonide administered by Turbuhaler: a double-blind, placebo-controlled study in adults with moderate-to-severe chronic asthma. Pulmicort Turbuhaler Study Group.
May 1998, Chest,
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
Treatment of croup with nebulised steroid (budesonide): a double blind, placebo controlled study.
March 1993, Archives of disease in childhood,
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
[Pseudocroup treated with inhaled steroid (budesonide). A double-blind placebo-controlled trial].
November 1994, Ugeskrift for laeger,
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
Randomised, double-blind, placebo-controlled trial of methotrexate in steroid-dependent asthma.
July 1990, Lancet (London, England),
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
Double-blind, placebo-controlled study of cyclosporin A as a corticosteroid-sparing agent in corticosteroid-dependent asthma.
February 1996, American journal of respiratory and critical care medicine,
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study.
October 2009, Gut,
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
A health-related quality-of-life comparison of formoterol (Oxis) Turbuhaler plus budesonide (Pulmicort) Turbuhaler with budesonide Turbuhaler alone and noncorticosteroid treatment in asthma: a randomized clinical study in Russia.
January 2002, Respiration; international review of thoracic diseases,
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
Lack of benefit of methotrexate in severe, steroid-dependent asthma. A double-blind, placebo-controlled study.
March 1991, Annals of internal medicine,
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler® in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study.
January 2012, Clinical drug investigation,
T Miyamoto, and T Takahashi, and S Nakajima, and S Makino, and M Yamakido, and K Mano, and M Nakashima, and U Tollemar, and O Selroos
Safety and Tolerability of High-Dose Budesonide/Formoterol via Turbuhaler® in Japanese Patients with Asthma : A Randomized, Double-Blind, Crossover, Active Comparator-Controlled, Phase III Study.
January 2012, Clinical drug investigation,
Copied contents to your clipboard!