Asthma
Conditions
Brief summary
To determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma
Interventions
DRUGIpratropium bromide
DRUGPlacebo
DRUGSalbutamol
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Boys or girls between 3 and 6 years old * Presenting to emergency departments with an acute asthmatic attack * Requiring nebulised bronchodilator therapy * Rint increased by 200 % compared to theoretical Rint * Signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (GCP) defined by the International Conference on Harmonization (ICH)
Exclusion criteria
* Ipratropium bromide received within four hours before admission * First acute asthmatic attack * Hospital admission to intensive care with asthma within six months before inclusion * Hospital admission for asthma during the month prior to inclusion * Corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy * Concomitant cardiac disease * Life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma * Hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients * Renal or hepatic insufficiency * Poorly controlled diabetes * Patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial * Past history of lung surgery * Major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to AIDS, cystic fibrosis * Patients unable to follow with protocol or correctly undergo the evaluations * Patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial * Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in pulmonary resistance (Rint) between T0 and T120 | Baseline, 120 minutes after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Changes in measurement of pulmonary resistance | Up to 120 minutes after drug administration |
| Assessment of accessory muscle recruitment on a 4-point scale | Up to 120 minutes after drug administration |
| Assessment of wheezing on a 4-point scale | Up to 120 minutes after drug administration |
| Assessment of dyspnoea on a 4-point scale | Up to 120 minutes after drug administration |
| Changes in respiratory rate | Up to 120 minutes after drug administration |
| Number of patients dropped out because of lack of efficacy | Up to 120 minutes after drug administration |
| Changes in Oxygen Saturation (ambient air) | Up to 120 minutes after drug administration |
| Number of patients dropped out because of adverse events | Up to 17 days after last drug administration |
| Number of patients with clinical significant findings in blood pressure | Up to 120 minutes after drug administration |
| Number of patients with clinical significant findings in heart rate | Up to 120 minutes after drug administration |
| Hospital Admission rate | 120 minutes after drug administration |
| Assessment of Patient Status by investigator on a 3-question list | 72 hours after drug admimistration |
| Number of patients with adverse events | Up to 17 days after last drug administration |
Outcome results
None listed