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A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma | Clinical Trials | Clareo Health

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A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

A 3-week Multicenter Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

NCT00130351•Novartis

View on ClinicalTrials.gov

Summary

This study is designed to investigate the ability of patients with asthma to properly use a new multi-dose dry powder inhaler (MDDPI) device in a real-life situation.

Eligibility

Age

5 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary
•Patients who have a current diagnosis of asthma
•Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility of at least 12% over baseline value following administration of a bronchodilator (i.e. "historical" reversibility) or demonstrate a \>12% increase in FEV1 over their baseline value within 30 minutes after inhalation of up to 360 µg (4 puffs) of albuterol at Visit 1. The administration of albuterol for the reversibility test must be within 30 minutes after baseline spirometry.

Exclusion Criteria

•Patients who were enrolled in study CFOR258F2304 or CFOR258F2306, or who have any experience using the Certihaler® device.
•QTc above 450 milliseconds for males and 470 milliseconds for females, or any findings on the screening electrocardiogram (ECG) that in the opinion of the investigator would present a safety hazard for continuation in the study
•Patients who have a known history of untoward reactions to sympathomimetic amines or to inhaled medications or to any of the individual components in those therapies

Locations (12)

Allergy and Asthma Specialists Medical Group and Research Ct

Huntington Beach, California, United States

Allergy and Asthma Medical Group & Research Center

San Diego, California, United States

Allergy & Asthma Associates of Santa Clara Res. Center

San Jose, California, United States

Colorado Allergy and Asthma Centers, PC

Denver, Colorado, United States

Colorado Allergy and Asthma Centers, PC

Englewood, Colorado, United States

Northeast Medical Research Associates, Inc.

North Dartmouth, Massachusetts, United States

Northeast Medical Research Associates, Inc

North Dartmouth, Massachusetts, United States

Clinical Research Institute

Minneapolis, Minnesota, United States

The Clinical Research Center

St Louis, Missouri, United States

The Asthma & Allergy Center, PC

Papillion, Nebraska, United States

Key Dates

Start Date

July 1, 2005

Primary Completion Date

August 1, 2005

Completion Date

August 1, 2005

Last Updated

May 19, 2023

Enrollment

155

ACTUAL participants

Conditions

Asthma

Interventions

formoterol

DEVICE

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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