NCT00460577 is a Phase 4 clinical trial of Formoterol fumerate in Acute Bronchial Obstruction, Asthma, sponsored by Novartis.

Who is sponsoring NCT00460577?

NCT00460577 is sponsored by Novartis.

What drugs are being tested in NCT00460577?

Interventions in NCT00460577: Formoterol fumerate, fenoterol/ipratropium bromide.

What condition does NCT00460577 study?

NCT00460577 studies Acute Bronchial Obstruction, Asthma.

Is NCT00460577 still recruiting?

NCT00460577 is currently completed. Last updated 23 March 2011.

Are results published for NCT00460577?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2011-03-23 · How we verify

NCT00460577

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 23 March 2011

What this trial tests

Phase 4 trial testing Formoterol fumerate in Acute Bronchial Obstruction, Asthma in 60 participants. Completed in 1 September 2008.

Timeline

1 March 2007

Primary endpoint
1 September 2008

1 September 2008

Quick facts

Lead sponsor	Novartis
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 March 2007
Primary completion	1 September 2008
Estimated completion	1 September 2008
Sites	2 locations across Venezuela

Drugs / interventions tested

Formoterol fumerate — full drug profile →
fenoterol/ipratropium bromide — full drug profile →

Conditions studied

Acute Bronchial Obstruction, Asthma — all drugs for Acute Bronchial Obstruction, Asthma →

Sponsor

Novartis — full company profile →

Who can join

Adults 5 to 12, any sex, with Acute Bronchial Obstruction, Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Novartis trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00460577 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis
Last refreshed: 23 March 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00460577.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing