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

NCT00273962 | Completed Phase 4

• 1 other identifier: 1012.45
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment

Secondary Outcomes (1)

• 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

Interventions

salbutamol UDV DRUG

ipratropium plus salbutamol UDV DRUG

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation.
• Male or female patients 2 to 10 years of age.
• Parents or legal guardians of patients must sign an Informed Consent Form prior to participation in the trial.

You may not qualify if:

• Patients with known or suspected hypersensitivity to study drugs
• Patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications
• Patients with first wheezing episode only
• Prior intubation for asthma for more than 24 hours
• Patients who used ipratropium within six hours prior to consultation
• Patients with concurrent stridor or possible presence of intra-thoracic foreign body
• Patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease)
• Patients requiring immediate resuscitation or airway intervention
• With psychiatric disease or psychosocial problems
• Patients on other investigational drugs or have used any other investigational drugs within the past month

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

Jose Reyes Memorial Medical Center

Manila, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

Amang Rodriguez Hospital

Marikina City, Philippines

Location

San Juan de Dios Hospital

Pasay, Philippines

Location

Rizal Provincial Hospital

Pasig, Philippines

Location

Philippine Children's Medical Center

Quezon, 1104, Philippines

Location

Quezon City General Hospital

Quezon, Philippines

Location

East Ave Medical Center

Quezon City, Philippines

Location

Philipines Heart Center

Quezon City, Philippines

Location

Quirino Memorial Medical Center

Quezon City, Philippines

Location

MeSH Terms

Conditions

Asthma

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. (Phil) Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 10, 2006
• Study Start: May 1, 2002
• Primary Completion: November 1, 2003
• Study Completion: November 1, 2003
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

PH (10)