AsthmaPhase 4NCT00273962
A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
A Phase 4 study testing ipratropium plus salbutamol UDV and salbutamol UDV in people with Asthma, run by Boehringer Ingelheim at 10 sites in Philippines.
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 Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Asthma
- What is being tested?
- ipratropium plus salbutamol UDV and salbutamol UDV
- How many people
- 500 participants
- Where
- 10 sitesPhilippines
- Study dates
- May 2002to Nov 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Philippines10 sites
Jose Reyes Memorial Medical Center
Manila
Philippine General Hospital
Manila
Amang Rodriguez Hospital
Marikina City
San Juan de Dios Hospital
Pasay
Rizal Provincial Hospital
Pasig
Philippine Children's Medical Center
Quezon, 1104
Quezon City General Hospital
Quezon
East Ave Medical Center
Quezon City
Philipines Heart Center
Quezon City
Quirino Memorial Medical Center
Quezon City
About this study
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
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
Read the detailed 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
- Conditions
- Asthma
- Being tested
- ipratropium plus salbutamol UDV, salbutamol UDV
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ipratropium plus salbutamol UDVDrug
salbutamol UDVDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startMay 2002
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. (Phil) Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273962
- Sponsor's protocol ID
- 1012.45
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 29 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00273962
- Acronym / sponsor ID
- 1012.45
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003
- First posted
- 10 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ipratropium plus salbutamol UDV | Drug | – |
| salbutamol UDV | Drug | – |
Primary outcome
The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. (Phil) Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ipratropium plus salbutamol UDV and salbutamol UDV in people with Asthma, run by Boehringer Ingelheim at 10 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients showing improvement in asthma severity scores from severe at baseline to mild at the end of the treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.