COPDPhase 1NCT03480997
Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD
A Phase 1 study testing Albuterol Sulfate and Ipratropium Bromide and Albuterol Sulfate in people with COPD, run by Pneuma Respiratory, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Albuterol Sulfate and Ipratropium Bromide and Albuterol Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2016to 28 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Respiratory and Sleep Medicine, PLLC
Hickory, North Carolina, 28601
About this study
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
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Albuterol Sulfate and Ipratropium Bromide, Albuterol Sulfate
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol Sulfate and Ipratropium BromideCombination product
Albuterol SulfateCombination product
| Study group | Role | What they receive |
|---|---|---|
| albuterol sulfate 100 mcg | Experimental | albuterol sulfate 100 mcg Test MDI Receives: Combination Product: Albuterol Sulfate |
| albuterol sulfate 200 mcg | Active comparator | albuterol sulfate 200 mcg Reference MDI Receives: Combination Product: Albuterol Sulfate |
| albuterol sulfate and ipratropium bromide | Experimental | albuterol sulfate 100 mcg and ipratropium bromide 20 mcg Test MDI Receives: Combination Product: Albuterol Sulfate and Ipratropium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Change in FEV1
Change in FEV1
Measured: Just prior to dosing and twenty minutes post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start27 Dec 2016
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pneuma Respiratory, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Stern, MD, Principal investigator, Advanced Respiratory and Sleep Medicine, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480997
- Sponsor's protocol ID
- 2016-01
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03480997
- Acronym / sponsor ID
- 2016-01
- Conditions
- COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pneuma Respiratory, IncIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| albuterol sulfate 100 mcg | Experimental | Combination Product: Albuterol Sulfatealbuterol sulfate 100 mcg Test MDI |
| albuterol sulfate 200 mcg | Active comparator | Combination Product: Albuterol Sulfatealbuterol sulfate 200 mcg Reference MDI |
| albuterol sulfate and ipratropium bromide | Experimental | Combination Product: Albuterol Sulfate and Ipratropium Bromidealbuterol sulfate 100 mcg and ipratropium bromide 20 mcg Test MDI |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol Sulfate and Ipratropium Bromide | Combination product | albuterol sulfate and ipratropium bromide |
| Albuterol Sulfate | Combination product | albuterol sulfate 100 mcg, albuterol sulfate 200 mcg |
Primary outcome
Primary Efficacy Endpoint: Change in FEV1
Time frame: Just prior to dosing and twenty minutes post dosing
Change in FEV1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Stern, MD principal investigator
Advanced Respiratory and Sleep Medicine, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Albuterol Sulfate and Ipratropium Bromide and Albuterol Sulfate in people with COPD, run by Pneuma Respiratory, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: Change in FEV1 (time frame: Just prior to dosing and twenty minutes post dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.