Aerosolized Beta-Agonist Isomers in Asthma

Asthma Clinical Trial

Official title:

Aerosolized Beta-Agonist Isomers in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170532
• Other study ID #: Pro00013822
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2014
• Last updated: August 11, 2014
• Start date: July 2007
• Est. completion date: July 2009

Study information

• Verified date: June 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.

Description:

Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• stable mild to moderate persistent asthma as defined by the National Asthma Education and Prevention Program

• greater than 18 years of age

• requiring bronchodilator therapy either routinely or on a as needed (PRN)basis

• stable with respect to respiratory disease and at least four weeks removed from the most recent acute exacerbation of the disease

• patients may or may not be on inhaled corticosteroids

Exclusion Criteria:

• no unstable cardiovascular symptoms

• no unstable angina

• must be at least four weeks removed from an acute coronary syndrome

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• levalbuterol
0.5 ml. levalbuterol
• saline
0.5ml saline

Other:
• levalbuterol MDI

Device:
• breath actuated nebulizer

• aerochamber max

Drug:
• ipratroprium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maximum Forced Expiratory Volume at One Second (FEV1)		Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment	No
Secondary	Change in 8 Hour Area-under-the-curve FEV1		0 to 8 hours post dose	No
Secondary	Change in Heart Rate		Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment	No
Secondary	Change in Tremor Assessment Measured by a Scale	Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).	Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment	No
Secondary	Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale		Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment	No