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Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT03256695
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
This is a 12-week, multicenter, open-label study to evaluate the relationship between as-needed usage of ABS eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease (moderate CE-COPD)/severe CE-COPD in adult patients at least 40 years of age with exacerbation-prone COPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: ABS eMDPI Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-Week, Open-Label Study to Evaluate the Relationship Between Use of Albuterol eMDPI, an Inhaled Short-Acting Beta Agonist "Rescue" Agent With an eModule, and Exacerbations in Patients (40 Years of Age or Older) With Chronic Obstructive Pulmonary Disease
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : April 17, 2018
Actual Study Completion Date : April 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Albuterol

Arm Intervention/treatment
Experimental: ABS eMDPI Drug: ABS eMDPI
The ABS eMDPI dose will be 90 mcg, 1 to 2 inhalations every 4 hours as needed.




Primary Outcome Measures :
  1. The total number of inhalations in the days preceding the peak of a CE-COPD [ Time Frame: 12 weeks ]
  2. The number of days prior to the peak of a CE-COPD when albuterol use increased [ Time Frame: 12 weeks ]
  3. The number of inhalations of albuterol uses in the 24 hours preceding a CE-COPD [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has had at least 1 episode of moderate or severe CE-COPD over the past 12 months before screening.
  • The patient must be able to demonstrate appropriate use of albuterol from the ABS eMDPI.
  • The patient is currently using a SABA reliever plus at least one of the following: long-acting beta agonist (LABA), an inhaled corticosteroid (ICS)/LABA, a long-acting muscarinic antagonist (LAMA), or a LABA/LAMA.
  • The patient is willing to discontinue all other rescue or maintenance SABA or anti-muscarinic agents and replace them with the study-provided ABS eMDPI for the duration of the trial.
  • The patient must be willing and able to comply with study requirements as specified in the protocol, including the use of a wearable accelerometer for the subset of patients who consent to use of the device.
  • The patient is willing to discontinue all other rescue or maintenance SABA or antimuscarinic agents and replace them with the study-provided ABS eMDPI for the duration of the trial.
  • Women of childbearing potential (not surgically sterile or ≥2 years postmenopausal) must have exclusively same-sex partners or use a highly effective method of birth control and must agree to continue the use of this method for the duration of the study and for 30 days after discontinuation of the IMP.

    • Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The patient has any clinically significant medical condition (treated or untreated) that, in the opinion of the investigator, would interfere with participation in the study.
  • The patient has any other confounding underlying lung disorder other than COPD.
  • The patient has used an investigational drug within 5 half-lives of it being discontinued or 1 month, whichever is longer.
  • The patient is a pregnant or lactating woman, or plans to become pregnant during the study. Note: Any woman becoming pregnant during the study will be withdrawn from the study.
  • The patient is known to be allergic to albuterol or lactose (milk protein).
  • The patient has a history or presence of "silent" infections, including positive testing for human immunodeficiency virus types 1 and 2, hepatitis B, hepatitis C, and tuberculosis.

    • Additional criteria apply, please contact the investigator for more information

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): NCT03256695


  Show 40 Study Locations
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT03256695     History of Changes
Other Study ID Numbers: ABS-COPD-30065
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract 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