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Trial record 76 of 862 for:    ALBUTEROL

Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03480997
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Pneuma Respiratory, Inc

Brief Summary:
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product as measured by increases in FEV1.

Condition or disease Intervention/treatment Phase
COPD Combination Product: Albuterol Sulfate and Ipratropium Bromide Combination Product: Albuterol Sulfate Phase 1

Detailed Description:
A single center, open label, single dose study to demonstrate the pharmacodynamic bioequivalence of the test and reference metered dose inhalers containing albuterol sulfate or albuterol sulfate/ipratropium in adult patients with COPD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center Study to Measure the Bronchodilator Effect of Albuterol Sulfate or Albuterol Sulfate/Ipratropium Bromide Using the Pneuma Respiratory Inhaler and the ProAir HFA Inhaler in Stable COPD Patients
Actual Study Start Date : December 27, 2016
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : April 28, 2017

Arm Intervention/treatment
Experimental: albuterol sulfate 100 mcg
albuterol sulfate 100 mcg Test MDI
Combination Product: Albuterol Sulfate
Active Comparator: albuterol sulfate 200 mcg
albuterol sulfate 200 mcg Reference MDI
Combination Product: Albuterol Sulfate
Experimental: albuterol sulfate and ipratropium bromide
albuterol sulfate 100 mcg and ipratropium bromide 20 mcg Test MDI
Combination Product: Albuterol Sulfate and Ipratropium Bromide

Primary Outcome Measures :
  1. Primary Efficacy Endpoint: Change in FEV1 [ Time Frame: Just prior to dosing and twenty minutes post dosing ]
    Change in FEV1

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provide written informed consent
  • Diagnosis of COPD as defined by the American Thoracic Society/European Respiratory Society guidelines characterized by progressive airflow limitation associated with abnormal inflammatory response of the lungs to noxious particles or gases primarily caused by cigarette smoking.
  • Have an established COPD clinical history, symptomatic with dyspnea, chronic cough, chronic sputum production or wheezing. At Visit 1, FEV1/FVC ratio must be less than 0.70 or at least 10% less than the FEV1/FVC ratio determined by the predicted normal value. FEV1 must be less than 70% of the predicted normal value and greater than 25% of the predicted normal value.
  • Must be using one or more inhaled bronchodilators for treatment of COPD at the time of Visit 1.
  • Current or former smokers, with a history of at least 10 pack-years of cigarette smoking. Number of pack-years = (number of cigarettes per day/20) X (number of years smoked).
  • Willing, and in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol.

Exclusion Criteria:

  • Current diagnosis of other respiratory disorder(s) including, but not limited to: alpha-1-antitrypsin deficiency; lung cancer; cystic fibrosis; tuberculosis; sarcoidosis; idiopathic pulmonary fibrosis; primary pulmonary hypertension; or pulmonary thromboembolic disease. Patients with concomitant COPD and asthma will be allowed to participate.
  • Diagnosis of non-respiratory disorder(s) that are currently affecting lung function, as determined by he principal investigator including, but not limited to: congestive heart failure; symptomatic cardiac arrhythmia; symptomatic seizure disorder; dementia; lupus; rheumatoid arthritis; or liver cirrhosis.
  • Unable to abstain from protocol defined prohibited medications during the screening and testing period.
  • Unable to withhold short acting bronchodilators for 6 hours prior to spirometry testing at the study visit.
  • Unable to perform acceptable or repeatable spirometry or comply with other study procedures.
  • Known allergic reaction to albuterol sulfate or ipratropium bromide.
  • Diagnosis of cancer that is not presumed to be in remission or cured.
  • Active alcohol or drug abuse.
  • Pregnant or lactating women. Pregnancy confirmed by a positive hCG test.
  • Treatment with another investigational study drug in another clinical study within the last 30 days or five half-lives, whichever is longer.

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 identifier (NCT number): NCT03480997

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United States, North Carolina
Advanced Respiratory and Sleep Medicine, PLLC
Hickory, North Carolina, United States, 28601
Sponsors and Collaborators
Pneuma Respiratory, Inc
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Principal Investigator: Tom Stern, MD Advanced Respiratory and Sleep Medicine, PLLC

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Responsible Party: Pneuma Respiratory, Inc Identifier: NCT03480997     History of Changes
Other Study ID Numbers: 2016-01
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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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
Cholinergic Antagonists
Cholinergic Agents