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Aerosolized Beta-Agonist Isomers in Asthma

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ClinicalTrials.gov Identifier: NCT02170532
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 4, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: levalbuterol Drug: saline Other: levalbuterol MDI Device: breath actuated nebulizer Device: aerochamber max Drug: ipratroprium Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aerosolized Beta-Agonist Isomers in Asthma
Study Start Date : July 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: levalbuterol + saline in a breath actuated nebulizer
0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer
Drug: levalbuterol
0.5 ml. levalbuterol

Drug: saline
0.5ml saline

Device: breath actuated nebulizer
Active Comparator: levalbuterol + ipratroprium in a breath actuated nebulizer
0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer
Drug: levalbuterol
0.5 ml. levalbuterol

Device: breath actuated nebulizer
Drug: ipratroprium
Active Comparator: levalbuterol MDI 2 puffs
levalbuterol metered dose inhaler 2 puffs
Other: levalbuterol MDI
Active Comparator: levalbuterol MDI + aerochamber max without pause 2 puffs
levalbuterol MDI + aerochamber max without pause 2 puffs
Other: levalbuterol MDI
Device: aerochamber max
Active Comparator: levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
levalbuterol MDI + aerochamber max with 2 second pause 2 puffs
Other: levalbuterol MDI
Device: aerochamber max



Primary Outcome Measures :
  1. Change in Maximum Forced Expiratory Volume at One Second (FEV1) [ Time Frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment ]

Secondary Outcome Measures :
  1. Change in 8 Hour Area-under-the-curve FEV1 [ Time Frame: 0 to 8 hours post dose ]
  2. Change in Heart Rate [ Time Frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment ]
  3. Change in Tremor Assessment Measured by a Scale [ Time Frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment ]
    Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).

  4. Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale [ Time Frame: Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170532


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Neil MacIntyre, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02170532     History of Changes
Other Study ID Numbers: Pro00013822
First Posted: June 23, 2014    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: August 13, 2014
Last Verified: June 2014
Keywords provided by Duke University:
asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action