Comparison of Two Bronchodilator Inhalers in Pediatric As... | NCT00112411

Studies
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

NCT00112411

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Status

Completed

Last Update Posted

Dec 8, 2021Actual

Enrollment

Not provided

Phase

Phase 2

Conditions

Asthma

Interventions

Bronchodilator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2005Actual

Primary Completion Date

Sep 30, 2005Actual

Completion Date

Sep 30, 2005Actual

First Submitted Date

Jun 2, 2005

First Submission Date that Met QC Criteria

Jun 2, 2005

First Posted Date

Jun 3, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2021

Last Update Posted Date

Dec 8, 2021Actual

Description Module

Brief Summary

This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Bronchodilator	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persistent asthma for a minimum of six months duration that has been stable for at least four weeks
Predicted FEV1 60-90%
Demonstration of 12% airway reversibility

Exclusion Criteria:

Continuous requirement for beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, anticholinergics and/or steroids other than those inhaled;
Presence of clinically-significant non-asthmatic acute or chronic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allergy Associates Medical Group, Inc.		San Diego	California	92120	United States
Aeroallergy Research Labs of Savannah, Inc.

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001993	Bronchodilator Agents

Ancestor Terms

ID	Term
D001337	Autonomic Agents
D018373	Peripheral Nervous System Agents
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided