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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02235428
• Other study ID #: 244.2413
• Status: Terminated
• Phase: Phase 4
• First received: September 9, 2014
• Last updated: September 9, 2014
• Start date: September 1998

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. primary completion date: September 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ipratropium bromide

• Placebo

• Salbutamol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in pulmonary resistance (Rint) between T0 and T120		Baseline, 120 minutes after drug administration	No
Secondary	Assessment of accessory muscle recruitment on a 4-point scale		Up to 120 minutes after drug administration	No
Secondary	Assessment of wheezing on a 4-point scale		Up to 120 minutes after drug administration	No
Secondary	Assessment of dyspnoea on a 4-point scale		Up to 120 minutes after drug administration	No
Secondary	Changes in respiratory rate		Up to 120 minutes after drug administration	No
Secondary	Changes in Oxygen Saturation (ambient air)		Up to 120 minutes after drug administration	No
Secondary	Changes in measurement of pulmonary resistance		Up to 120 minutes after drug administration	No
Secondary	Number of patients dropped out because of lack of efficacy		Up to 120 minutes after drug administration	No
Secondary	Number of patients with adverse events		Up to 17 days after last drug administration	No
Secondary	Number of patients dropped out because of adverse events		Up to 17 days after last drug administration	No
Secondary	Number of patients with clinical significant findings in blood pressure		Up to 120 minutes after drug administration	No
Secondary	Number of patients with clinical significant findings in heart rate		Up to 120 minutes after drug administration	No
Secondary	Hospital Admission rate		120 minutes after drug administration	No
Secondary	Assessment of Patient Status by investigator on a 3-question list		72 hours after drug admimistration	No

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