Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01232322
Other study ID # D5257L00014
Secondary ID
Status Completed
Phase N/A
First received October 31, 2010
Last updated January 23, 2013
Start date October 2006
Est. completion date July 2011

Study information

Verified date January 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and WelfareJapan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage.


Recruitment information / eligibility

Status Completed
Enrollment 633
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 5 Years
Eligibility Inclusion Criteria:

- Patients treated with Pulmicort Respules for the first time due to bronchial asthma

- Children of >= 6 months and < 5 years old age at the start of study treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events Range of 3 years Yes
Primary Effects on growth rate Variation of the height/weight from the baseline. Range of 3 years Yes
Primary Effects on the adrenal cortical function. Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort. Range of 3 years Yes
Primary Effects on development of infections. Existence and type of infections. Range of 3 years Yes
Secondary Clinical course under Pulmicort long-term use Validation of the frequency of asthmatic attack, level of the asthmatic attack, daily life, night sleep from baseline No
See also
  Status Clinical Trial Phase
Recruiting NCT02934945 - Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients Phase 4
Completed NCT02561351 - Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation N/A
Recruiting NCT01759472 - Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Effect Study of Montelukast to Treat Asthma Detected by LTD4 Bronchial Provocation Test N/A
Completed NCT01918293 - Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma): Adult N/A
Completed NCT01203904 - Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation N/A
Completed NCT01762917 - Influence of Bag Volume Variation on the Reproducibility of Inert Gas Rebreathing N/A
Completed NCT00536731 - Symbicort Rapihaler Therapeutic Equivalence Study Phase 3
Completed NCT00930826 - Childhood Asthma and Schooling: The Truth Unveiled N/A
Completed NCT00331929 - Respiratory Health Study of Children in Kiryat Tivon N/A
Completed NCT00327028 - Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma Phase 4
Completed NCT00413387 - Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®) Phase 3
Completed NCT00153283 - Study of Efficacy of Gabapentin in Therapy of Bronchial Asthma Phase 4
Completed NCT00950794 - Study of Salmeterol (SN408D) for Adult Asthma Phase 4
Completed NCT00142025 - Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma Phase 4
Completed NCT00153270 - Study of Efficacy of Sodium Valproate in Therapy of Bronchial Asthma Phase 4
Completed NCT03450434 - XC8 in the Treatment of Patients With Bronchial Asthma Phase 2
Recruiting NCT05189613 - Mepolizumab Effectiveness in Severe Eosinophilic Asthma and Bronchiectasis N/A
Recruiting NCT04128111 - Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma
Completed NCT06326632 - Comparative Effectiveness Study of Constant-Load Versus Graded Aerobic Exercise in Obese Children With Bronchial Asthma N/A
Completed NCT05088512 - The Role of Genetic Factors in the Development of Bronchial Asthma in the Kazakh Population