Clinical trial NCT02235428: Study to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, in Acute Asthmatic Attacks in Young Children
Official title: Double-blind, Controlled Trial to Assess the Efficacy of Ipratropium Bromide Associated With High Dose Salbutamol by Repeated Nebulisation Versus Repeat Nebulisation of Salbutamol Alone, for 120 Minutes, in Acute Asthmatic Attacks in Young Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-10
Enrollment: 3
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in pulmonary resistance (Rint) between T0 and T120
timeFrame: Baseline, 120 minutes after drug administration
Secondary outcomes:
measure: Assessment of accessory muscle recruitment on a 4-point scale
timeFrame: Up to 120 minutes after drug administration
measure: Assessment of wheezing on a 4-point scale
timeFrame: Up to 120 minutes after drug administration
measure: Assessment of dyspnoea on a 4-point scale
timeFrame: Up to 120 minutes after drug administration
measure: Changes in respiratory rate
timeFrame: Up to 120 minutes after drug administration
measure: Changes in Oxygen Saturation (ambient air)
timeFrame: Up to 120 minutes after drug administration
measure: Changes in measurement of pulmonary resistance
timeFrame: Up to 120 minutes after drug administration
measure: Number of patients dropped out because of lack of efficacy
timeFrame: Up to 120 minutes after drug administration
measure: Number of patients with adverse events
timeFrame: Up to 17 days after last drug administration
measure: Number of patients dropped out because of adverse events
timeFrame: Up to 17 days after last drug administration
measure: Number of patients with clinical significant findings in blood pressure
timeFrame: Up to 120 minutes after drug administration
measure: Number of patients with clinical significant findings in heart rate
timeFrame: Up to 120 minutes after drug administration
measure: Hospital Admission rate
timeFrame: 120 minutes after drug administration
measure: Assessment of Patient Status by investigator on a 3-question list
timeFrame: 72 hours after drug admimistration
Other outcomes:
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