A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)

Asthma Clinical Trial

Official title:

A Comparison of Combivent® UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg) in a Double-Blind Efficacy and Safety Study in Asthmatic Children With Severe Acute Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273962
• Other study ID #: 1012.45
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2006
• Last updated: October 28, 2013
• Start date: May 2002
• Est. completion date: November 2003

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial Summary

To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with salbutamol alone given every 20 minutes for three doses in asthmatic children with severe acute exacerbation

Description:

A Comparison of Ipratropium 500mcg and salbutamol 2.5mg (Combivent UDV) and salbutamol UDV alone (2.5mg) in a Double-blind, Efficacy and Safety Study in Asthmatic Children with Severe Acute Exacerbation

Study Hypothesis:

Several studies, including a study conducted in an emergency room setting, demonstrated that the addition of ipratropium bromide, an anticholinergic drug, to standard salbutamol therapy significantly improves pulmonary function as compared to salbutamol alone.

Comparison(s):

Ipratropium bromide 500 mcg plus salbutamol 2.5mg (Combivent) vs salbutamol (2.5mg) alone given every 20 minutes for 3 doses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 2003
• Est. primary completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

INCLUSION CRITERIA

1. All patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation.

2. Male or female patients 2 to 10 years of age.

3. Parents or legal guardians of patients must sign an Informed Consent Form prior to participation in the trial.

EXCLUSION CRITERIA

1. Patients with known or suspected hypersensitivity to study drugs

2. Patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications

3. Patients with first wheezing episode only

4. Prior intubation for asthma for more than 24 hours

5. Patients who used ipratropium within six hours prior to consultation

6. Patients with concurrent stridor or possible presence of intra-thoracic foreign body

7. Patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease)

8. Patients requiring immediate resuscitation or airway intervention

9. With psychiatric disease or psychosocial problems

10. Patients on other investigational drugs or have used any other investigational drugs within the past month

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ipratropium plus salbutamol UDV

• salbutamol UDV

Locations

Country	Name	City	State
Philippines	Jose Reyes Memorial Medical Center	Manila
Philippines	Philippine General Hospital	Manila
Philippines	Amang Rodriguez Hospital	Marikina
Philippines	San Juan de Dios Hospital	Pasay
Philippines	Rizal Provincial Hospital	Pasig
Philippines	Philippine Children's Medical Center	Quezon
Philippines	Quezon City General Hospital	Quezon
Philippines	East Ave Medical Center	Quezon City
Philippines	Philipines Heart Center	Quezon City
Philippines	Quirino Memorial Medical Center	Quezon City

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment
Secondary	Change in asthma severity scores from baseline to end of treatment; number of patients needing hospitalization; number of rescue medications; oxygen saturation, number of discharged patients revisiting the ER/doctors clinic