Unique ID issued by UMIN | UMIN000008912 |
---|---|
Receipt number | R000010451 |
Scientific Title | A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy |
Date of disclosure of the study information | 2012/10/01 |
Last modified on | 2014/12/10 10:16:51 |
A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy
A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy
A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy
A randomized open-label parallel-group trial to evaluate the efficacies of step-up and step-down therapies using budesonide/formoterol combination (160/4.5 mcg) in patients with poorly controlled asthma even after inhaled corticosteroid therapy
Japan |
bronchial asthma
Pneumology | Clinical immunology |
Others
NO
To compare the efficacies of step-down and step-up therapies using budesonide/formoterol combination in patients with poorly controlled asthma after inhaled corticosteroid monotherapy
Safety,Efficacy
Percentage of the number of days on which asthma is well controlled in the patients during the entire treatment period
(1) The outcomes after 12 and 24 weeks of treatment are as follows:
* Change in the results of respiratory function tests from the ones obtained before treatment
* Change in exhaled nitric oxide level from that before treatment
* Change in respiratory resistance from the pretreatment observation
(2) The parameters analyzed during the entire treatment period are as follows:
* Asthma symptom scores for daytime and nighttime
* Asthma Control Questionnaire score
* Frequency of use of relievers in daytime and nighttime
* Total number of weeks in which well-controlled asthma status is achieved
* Episodes of nocturnal awaking due to asthma symptoms
* Adherence to study drug consumption in the morning and evening
(3) Adverse event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Step-down therapy group:
Initially, budesonide/formoterol combination will be administered at the dosage of 2 inhalations twice a day (bid) for 12 weeks. If asthma is well controlled, the dosage will be changed to 1 inhalation bid. However, if asthma is not well controlled, the dosage will be changed to 4 inhalations bid. The drug will be then administered for the subsequent 12 weeks.
Step-up therapy group:
Initially, budesonide/formoterol combination is administrated at the dose of 1 inhalation b.i.d. for 12 weeks. If their asthma becomes uncontrolled, the dose is changed to 2 inhalations b.i.d, and if well-controlled, the dose is not changed. Then, the drug is administrated for the subsequent 12 weeks.
20 | years-old | <= |
Not applicable |
Male and Female
* Male and female outpatients, who are aged at least 20 years
* Treatment with inhaled corticosteroid at a dosage equivalent to 400 to 800 mcg/day or a lower dose of budesonide for at least 4 weeks, immediately before the patients are enrolled
* Patients with poorly controlled asthma
* Those who can provide written consent
* Patients with a history of hypersensitivity to components of budesonide/formoterol combination (including contact dermatitis)
* Patients with an infectious disease or deep mycosis, both of which cannot be treated effectively by any antimicrobial drug
* Patients with tuberculosis
* Patients with a history of usage of long-acting beta agonist or some drug containing a long-acting beta agonist within 4 weeks before enrollment
* Patients with a respiratory infectious disease that affects asthma; onset of the infection should have occurred within 4 weeks before enrollment
* Patients receiving beta-blocker, including an eye drop
* Patients who are administered a systemic steroid within 30 days before enrollment
* Patients with a clinically serious comorbidity
* Patients with FEV1 values less than 60% of the predicted value
* Smokers or patients with a smoking history of more than 10 pack-years, or a former smoker who stopped smoking in the 6 months before enrollment
* Patients who are planning to become pregnant, or who are pregnant, or are breast-feeding
* Those who cannot provide a written informed consent by themselves
* Those concluded to be ineligible by the investigator
100
1st name | |
Middle name | |
Last name | Takashi Iwanaga |
Kinki University, Faculty of Medicine
Department of Respiratory Medicine and Allergology
377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan
072-366-0221
crs@mcp.co.jp
1st name | |
Middle name | |
Last name | Takashi Iwanaga |
Kinki University, Faculty of Medicine
Department of Respiratory Medicine and Allergology
377-2 Ohnohigashi, Osakasayama, Osaka 589-8511, Japan
072-366-0221
crs@mcp.co.jp
Kinki Respiratory and Allergy Diseases Research Group
Japan Allergy Foundation
Non profit foundation
NO
近畿大学医学部附属病院(大阪府)
近畿大学医学部奈良病院(奈良県)
近畿大学医学部堺病院(大阪府)
橋本市民病院(大阪府)
2012 | Year | 10 | Month | 01 | Day |
Unpublished
No longer recruiting
2012 | Year | 08 | Month | 24 | Day |
2013 | Year | 04 | Month | 01 | Day |
2015 | Year | 05 | Month | 31 | Day |
2012 | Year | 09 | Month | 13 | Day |
2014 | Year | 12 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010451