asthma
Conditions
Interventions
tulobuterol patch (TP)
theophylline (Theo)
Sponsors
PARG (Pediatric Asthma Research Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  Children with bronchial asthma under treatment for mild persistent asthma.  Children who still have wheezing and dyspnea despite of treatment with an anti-LT.  Children who are 4~12 years of age and show stable PEF measurements (note). Note) Stable PEF measurements are defined as that the difference between the second highest and the highest PEF measurement is lower 15% lower than the highest PEF measurement among three consecutive measurements of PEF.  Children who (or whose parents) have given informed consent for participation in the present study.
Exclusion criteria
Exclusion criteria:  Children who are receiving long-acting beta2 agonists (tulobuterol patch or inhaled salmeterol) or oral beta2 agonists regularly.  Children with a history of hypersensitivity to tulobuterol patch, and children with dermal diseases such as atopic dermatitis for whom treatment with tulobuterol patch are considered inappropriate.  Children with hyperthyroidism, hypertension, heart disease or diabetes mellitus for whom treatment with beta2 agonists is considered inappropriate.  Children with a history of serious adverse effects of tulobuterol.  Children with a history of serious adverse effects of theophylline.  Children with epilepsy, hyperthyroidism, acute nephritis, congestive heart failure or liver disorder for whom treatment with theophylline is considered inappropriate.  Children with neurological dispositions (e.g., epilepsy, convulsions and abnormal EEG)  Children with fever  Any other children for whom participation in the survey is considered inappropriate by the attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Pulmonary function Morning and evening PEF 2) Airway inflammation: expired NO | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Asthma symptoms (evaluate on the basis of the patient diary) Asthma score: Symptoms, activities of daily living, nocturnal sleep, frequency of attacks, number of days without symptoms 2) Frequency of use of inhaled/oral beta2 agonists (as single doses) 3) Concomitant symptoms (adverse effects for which causal relationship with the treatment cannot be ruled out) 4) Frequency of occurence of adverse effects | — |
Countries
Japan
Contacts
Public ContactKeiko Saito, Kumiko Ohta
PARG PARG
Outcome results
None listed