A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00273962 |
Recruitment Status :
Completed
First Posted : January 10, 2006
Last Update Posted : October 29, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: ipratropium plus salbutamol UDV Drug: salbutamol UDV | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2002 |
Actual Primary Completion Date : | November 2003 |
Study Completion Date : | November 2003 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 10 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
- 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.
EXCLUSION CRITERIA
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00273962
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 | |
East Ave Medical Center | |
Quezon City, Philippines | |
Philipines Heart Center | |
Quezon City, Philippines | |
Quirino Memorial Medical Center | |
Quezon City, Philippines | |
Philippine Children's Medical Center | |
Quezon, Philippines, 1104 | |
Quezon City General Hospital | |
Quezon, Philippines |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. (Phil) Inc. |
ClinicalTrials.gov Identifier: | NCT00273962 |
Other Study ID Numbers: |
1012.45 |
First Posted: | January 10, 2006 Key Record Dates |
Last Update Posted: | October 29, 2013 |
Last Verified: | October 2013 |
Albuterol Ipratropium Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Tocolytic Agents |
Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Cholinergic Agents |