Aerosolized Beta-Agonist Isomers in Asthma

NCT02170532 | Completed Phase 4 Results

• 1 other identifier: Pro00013822
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• Change in Maximum Forced Expiratory Volume at One Second (FEV1)

  Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

Secondary Outcomes (4)

• Change in 8 Hour Area-under-the-curve FEV1

  0 to 8 hours post dose

• Change in Heart Rate

  Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

• Change in Tremor Assessment Measured by a Scale

  Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment

• 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

Study Arms (5)

levalbuterol + saline in a breath actuated nebulizer

ACTIVE COMPARATOR

0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer

Drug: levalbuterol; Drug: saline; Device: breath actuated nebulizer

levalbuterol + ipratroprium in a breath actuated nebulizer

ACTIVE COMPARATOR

0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer

Drug: levalbuterol; Device: breath actuated nebulizer; Drug: ipratroprium

levalbuterol MDI 2 puffs

ACTIVE COMPARATOR

levalbuterol metered dose inhaler 2 puffs

Other: levalbuterol MDI

levalbuterol MDI + aerochamber max without pause 2 puffs

ACTIVE COMPARATOR

levalbuterol MDI + aerochamber max without pause 2 puffs

Other: levalbuterol MDI; Device: aerochamber max

levalbuterol MDI + aerochamber max with 2 second pause 2 puffs

ACTIVE COMPARATOR

levalbuterol MDI + aerochamber max with 2 second pause 2 puffs

Other: levalbuterol MDI; Device: aerochamber max

Interventions

levalbuterol DRUG

0.5 ml. levalbuterol

levalbuterol + ipratroprium in a breath actuated nebulizer; levalbuterol + saline in a breath actuated nebulizer

saline DRUG

0.5ml saline

levalbuterol + saline in a breath actuated nebulizer

levalbuterol MDI OTHER

levalbuterol MDI + aerochamber max with 2 second pause 2 puffs; levalbuterol MDI + aerochamber max without pause 2 puffs; levalbuterol MDI 2 puffs

breath actuated nebulizer DEVICE

levalbuterol + ipratroprium in a breath actuated nebulizer; levalbuterol + saline in a breath actuated nebulizer

aerochamber max DEVICE

levalbuterol MDI + aerochamber max with 2 second pause 2 puffs; levalbuterol MDI + aerochamber max without pause 2 puffs

ipratroprium DRUG

levalbuterol + ipratroprium in a breath actuated nebulizer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• no unstable cardiovascular symptoms
• no unstable angina
• must be at least four weeks removed from an acute coronary syndrome

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Asthma

Interventions

Levalbuterol; Sodium Chloride

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Neil MacIntyre, MD
• Organization: Duke University Medical Center

macin001@mc.duke.edu

(919) 681-2720

Study Officials

• Neil MacIntyre, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: July 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 13, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-06