Acute Bronchial Obstruction, AsthmaPhase 4NCT00460577

Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction

A Phase 4 study testing Formoterol fumerate and fenoterol/ipratropium bromide in people with Acute Bronchial Obstruction, Asthma, run by Novartis at 2 sites in Venezuela.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-<12 years) with acute bronchial obstruction attending emergency services Read more about this study

Who is it for?: Ages 5 to 12 years
Conditions the study is for: Acute Bronchial Obstruction, Asthma
What is being tested?: Formoterol fumerate and fenoterol/ipratropium bromide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesVenezuela
Study dates: Mar 2007to Sep 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 5 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence

Who cannot join

Patients with severe acute bronchial obstruction determined by functional and clinical evidence
Patients unable to use the inhaling device at time of treatment
Patients who received a bronchodilator drug within the last 12 hours
Patients who received inhaled steroids within the last 72 hours
Patients who received systemic steroids within the last 7 days
Patients with near fatal asthma history

Show all 9Show fewer

Patients with fever (>38.5°C axillar temp)
Patients with any clinical significance condition
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

2 sites in 1 country.

Venezuela2 sites

Novartis Investigator site - five sites in Caracas
Caracas
Novartis Investigator Site
Maracaibo

Other trials in Venezuela

About this study

Official title: Randomized, Double Blind, Double Dummy, Placebo Controlled Trial to Compare the Effectiveness of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Asthmatic Children (5-<12 Years) With Acute Bronchial Obstruction Attending Emergency Services

Conditions: Acute Bronchial Obstruction, Asthma
Being tested: Formoterol fumerate, fenoterol/ipratropium bromide
Keywords: Asthma, Formoterol, Bronchial Obstruction, Children
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Formoterol fumerateDrug
12 micrograms stat (twice if necessary). Inhaled via aerolizer
fenoterol/ipratropium bromideDrug
0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.

Study groups in NCT00460577
Study group	Role	What they receive
Formoterol (Foradil®)	Active comparator	Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. Receives: Drug: Formoterol fumerate
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg	Active comparator	Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized. Receives: Drug: fenoterol/ipratropium bromide

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.
Measured: Baseline,4 hours
Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.
Measured: Baseline,4 hours
Mean Change in Pulse Oxymetry From Baseline to Final Evaluation
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.
Measured: Baseline, 4 hours
Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.
Measured: Baseline,4 hours

Secondary outcomes (2)

Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events
Not posted: see comment in Limitations and Caveats.
Measured: 4 hours
Pharmacoeconomic Analysis
Pharmacoeconomic analysis comparing the mean direct costs (total cost per prescription) of treatment with Formoterol (Foradil®) to treatment with Fenoterol 0.5 mg + Berodual®.
Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Sep 2008

First posted16 Apr 2007 (estimated)
Study startMar 2007
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Bronchial Obstruction, AsthmaStudies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00460577
Sponsor's protocol ID: CFOR258DVE02
Status last verified: Mar 2011
First submitted: 13 Apr 2007
Last updated: 19 Apr 2011
Results posted: Yes, on ClinicalTrials.gov

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double Blind, Double Dummy, Placebo Controlled Trial to Compare the Effectiveness of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Asthmatic Children (5-<12 Years) With Acute Bronchial Obstruction Attending Emergency Services
ClinicalTrials.gov ID: NCT00460577
Acronym / sponsor ID: CFOR258DVE02
Conditions: Acute Bronchial Obstruction, Asthma
Keywords: Asthma, Formoterol, Bronchial Obstruction, Children
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 16 Apr 2007 (estimated)
Results: Posted 19 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Formoterol (Foradil®)	Active comparator	Drug: Formoterol fumerateFormoterol (Foradil®) 12 micrograms administered through Aerolizer®.
Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg	Active comparator	Drug: fenoterol/ipratropium bromideFenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.

Who may qualify

Ages: 5 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial obstruction mild to moderate determined by functional and clinical evidence

Key exclusion criteria (9 listed)

Patients with severe acute bronchial obstruction determined by functional and clinical evidence
Patients unable to use the inhaling device at time of treatment
Patients who received a bronchodilator drug within the last 12 hours
Patients who received inhaled steroids within the last 72 hours
Patients who received systemic steroids within the last 7 days

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
Formoterol fumerate12 micrograms stat (twice if necessary). Inhaled via aerolizer	Drug	Formoterol (Foradil®)
fenoterol/ipratropium bromide0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.	Drug	Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg

Primary outcome

Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation
Time frame: Baseline,4 hours
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Maximum Expiratory Flow.
Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation
Time frame: Baseline,4 hours
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Forced Expiratory Volume in 1 second. FEV1 is defined as the volume of air that can be forced out of the lungs in 1 second after taking a deep breath.
Mean Change in Pulse Oxymetry From Baseline to Final Evaluation
Time frame: Baseline, 4 hours
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by Pulse Oximetry used to monitor the percentage of oxygen saturation of hemoglobin in the blood.
Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation
Time frame: Baseline,4 hours
Mean Change from Baseline to Final Evaluation in the Per Protocol population assessed by the Conway Clinical Scale. Assessment of the following: Wheezing, Accessory Muscle Use and Pulse Frequency in a 0 to 3 point scale according to severity for a minimum of 0 points and a total of 9 points in a very severe clinical case.

2 secondary outcomes

Safety Assessed by: Pulse Oxymetry, Clinical Assessments, Adverse Events
Time frame: 4 hours
Pharmacoeconomic Analysis
Time frame: 4 hours

Results and safety

Results posted to the registry on 19 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Formoterol (Foradil®)	30	28
Fenoterol 0.5 mg + Berodual®	30	24

Primary outcome: Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation

Time frame: Baseline,4 hours. Mean (Standard Deviation). Unit: Liters/minute

Measure	Formoterol (Foradil®) n = 28	Fenoterol 0.5 mg + Berodual® n = 24
Value	44 (26.87)	43.67 (20.48)

Population analysed: Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.

Primary outcome: Mean Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Final Evaluation

Time frame: Baseline,4 hours. Mean (Standard Deviation). Unit: Liters

Measure	Formoterol (Foradil®) n = 28	Fenoterol 0.5 mg + Berodual® n = 24
Value	0.32 (0.2)	0.34 (0.22)

Population analysed: Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.

Primary outcome: Mean Change in Pulse Oxymetry From Baseline to Final Evaluation

Time frame: Baseline, 4 hours. Mean (Standard Deviation). Unit: percentage

Measure	Formoterol (Foradil®) n = 28	Fenoterol 0.5 mg + Berodual® n = 24
Value	2.57 (1.67)	2.83 (2.51)

Population analysed: Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.

Primary outcome: Mean Change in the Conway Clinical Scale Score From Baseline to Final Evaluation

Time frame: Baseline,4 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Formoterol (Foradil®) n = 28	Fenoterol 0.5 mg + Berodual® n = 24
Value	-3.18 (1.59)	-3.04 (1.83)

Population analysed: Per protocol population: defined as number of patients who did not present any major deviations from protocol and received at least one dose of investigational study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Formoterol (Foradil®)	0 of 30 (0%)	0 of 30 (0%)	Not reported
Fenoterol 0.5 mg + Berodual®	0 of 30 (0%)	0 of 30 (0%)	Not reported

Limitations and caveats (from the sponsor): Secondary Outcome Measure 2: Safety Assessed by Pulse Oxymetry, Clinical Assessments, Adverse Events has not been posted. Analysis of Pulse Oxymetry and Clinical Assessment was not performed. Adverse events are reported in the Adverse Event section.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Novartis de Venezuela study chair

Novartis de Venezuela

2 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 Formoterol fumerate and fenoterol/ipratropium bromide in people with Acute Bronchial Obstruction, Asthma, run by Novartis at 2 sites in Venezuela.

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 1 inclusion and 9 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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Venezuela. 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?

Yes. Results are posted in the registry (first posted 19 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change in Maximum Expiratory Flow From Baseline to Final Evaluation (time frame: Baseline,4 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00460577.

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 19 Apr 2011.