COPD ExacerbationNCT02291016
COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers
A study testing Formoterol in people with COPD Exacerbation, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Formoterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or past cigarette smoking history of >/= 10 pack-years.
- FEV1/FVC ratio </= 70%.
- Known diagnosis of COPD.
- Current hospitalization for a primary diagnosis of acute exacerbation of COPD.
- Must be able to understand and willing to sign an informed consent document.
Who cannot join
- On a ventilator or mask ventilation.
- Allergy or contraindication to Formoterol use.
- Marked QTc prolongation (> 450 ms).
- Liver cirrhosis or chronic renal insufficiency (serum creatinine > 2 mg/dL).
- Atrial fibrillation with rapid ventricular response (heart rate > 110 bpm) or ventricular arrhythmia (frequent PVCs, ventricular tachycardia).
- Acute myocardial infarction within 12 weeks of patient study registration.
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- Known pulmonary embolism.
- Known or suspected lung cancer.
- Known neuromuscular disease, stroke with residual hemiparesis, or untreated Parkinsonism
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or sub dermal implants).
- Inability to understand instructions.
- Participation in another investigational drug clinical trial within 30 days of patient study registration.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
About this study
Official title: A Randomized, Double-Dummy, Crossover, Single-Center Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers in the Treatment of Patients Recovering From Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.
- Conditions
- COPD Exacerbation
- Being tested
- Formoterol, Placebo
- Keywords
- COPD, chronic obstructive pulmonary disease
- 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.
FormoterolDrug
Also called Foradil, PERFOROMIST
Comparison of dosage administered via a nebulizer versus dosage administered via a dry powder inhaler. 12 µg Formoterol with the dry powder inhaler and 20 µg (solution form) of Formoterol with the nebulizer. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
PlaceboOther
Also called Normal Saline
Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
| Study group | Role | What they receive |
|---|---|---|
| Formoterol via DPI then Formoterol via nebulizer | Active comparator | Group A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2.
Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2. Receives: Drug: Formoterol; Other: Placebo |
| Formoterol via nebulizer then Formoterol via DPI | Active comparator | Group B: Received Formoterol 20 µg (solution form) via nebulizer and placebo via a DPI at treatment visit #1, and Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2.
Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2. Receives: Drug: Formoterol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference Between the Values of Area Under the Response Curve for FEV1
The difference between the values of area under the response curve for FEV1 from baseline through four hours (AUC FEV1 0-4h) after inhalation of formoterol with a nebulizer or a dry powder inhaler.
Measured: Baseline through study completion (visit 1 through visit 2)
Secondary outcomes (8)
Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol
Change in peak FEV1 from Baseline. This will be completed at visit 1 and visit 2.
Steps:
- A baseline (pre-dose formoterol) FEV1 will be recorded.
- Subjects will be dosed with formoterol.
- Serial FEV1 assessments will completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so a peak measurement can be recorded.
- A percentage of change between the baseline and peak FEV1 will be recorded for this outcome measure. A higher value indicates a better result.
Measured: From pre-dose formoterol (baseline 0hrs) to 30 minutes, 1,2, and 4 hours post dose at visit 1 and measured again at visit 2
Absolute Increase in FEV1 From Baseline After Inhalation of Formoterol
Increase in FEV1 from Baseline to 4 hours post dose of formoterol. This will be completed at visit 1 and visit 2.
Steps:
- A baseline (pre-dose formoterol) FEV1 was recorded.
- Subjects was dosed with formoterol.
- Serial FEV1 assessments were completed, and recorded at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so serial FEV1 measurements could be recorded.
Measured: Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completed
Peak FEV1 Between the Two Devices (Nebulizer and DPI)
Change in peak FEV1 from Baseline. This will be completed at visit 1 and visit 2.
Steps:
- A baseline (pre-dose formoterol) FEV1 was recorded.
- Subjects were dosed with formoterol.
- Serial FEV1 assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so a peak measurement could recorded.
- Peak measurements from visit 1 and visit 2 will be compared for any significant change in FEV1 values.
Measured: Measured from Start of visit 1 until the completion of visit 2
Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol
Change in FEV1 from Baseline through 4 hours post formoterol dose. This was completed at visit 1 and visit 2.
Steps:
- A baseline (pre-dose formoterol) FEV1 was recorded.
- Subjects were dosed with formoterol.
- Serial FEV1 assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FEV1 values were recorded.
- A percentage of change from baseline FEV1 to each serial measurement of FEV1 was collected. The % of change at each time point was then used to get a measure of overall percentage change of the predicted FEV1 value.
Measured: Baseline through study completion (visit 1 through visit 2)
Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol
Steps:
- A baseline (pre-dose formoterol) FVC was recorded.
- Subjects were dosed with formoterol.
- Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.
Data was all time points were used to obtain the total area under the curve
Measured: Measured at visit 1 and again at the end of visit 2
Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol
- A baseline (pre-dose formoterol) FVC was recorded.
- Subjects were dosed with formoterol.
- Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.
- A percentage of change between the baseline and peak FVC will be recorded for this outcome measure.
Measured: Measured at visit 1 and again at the end of visit 2
Peak FVC Between the Two Devices (Nebulizer and DPI)
Steps:
- A baseline (pre-dose formoterol) FVC was recorded.
- Subjects were dosed with formoterol.
- Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.
- Peak FVC was recorded for this outcome measure and compared amongst groups.
Measured: Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change.
Change in Dyspnea Based on the Borg Dyspnea Scale for Shortness of Breath (Pre-dose Administration and 60 Minutes After Inhalation of Formoterol With a Nebulizer or a DPI)
The Shortness of Breath Modified Borg Dyspnea Scale The scale goes from 0-10, zero meaning no difficulty breathing and ten meaning maximal difficulty. A decrease of score indicates an improvement. Patients were asked to complete the scale pre-dose and again one hour post formoterol dose. This was completed at both visit 1 and visit 2. The value recorded was the difference between the baseline value and the post 60 minute value.
Measured: Measured at visit 1 and again at the end of visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COPD ExacerbationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mylan Specialty, LP
- Responsible party
- Principal investigator, Rajiv Dhand, MD, University of Tennessee Graduate School of Medicine
- Investigators
- Rajiv Dhand, MD, Principal investigator, University of Tennessee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291016
- Sponsor's protocol ID
- 3798
- Status last verified
- Feb 2019
- First submitted
- 5 Nov 2014
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Dummy, Crossover, Single-Center Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers in the Treatment of Patients Recovering From Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02291016
- Acronym / sponsor ID
- 3798
- Conditions
- COPD Exacerbation
- Keywords
- COPD, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Mylan Specialty, LP
- Study start
- Feb 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Posted 19 Mar 2019
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 compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formoterol via DPI then Formoterol via nebulizer | Active comparator | Drug: Formoterol, Other: PlaceboGroup A: Received Formoterol 12 µg via DPI and placebo via nebulizer at treatment visit #1, and Formoterol 20 µg (solution form) via nebulizer and placebo via DPI at treatment visit 2. Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2. |
| Formoterol via nebulizer then Formoterol via DPI | Active comparator | Drug: Formoterol, Other: PlaceboGroup B: Received Formoterol 20 µg (solution form) via nebulizer and placebo via a DPI at treatment visit #1, and Formoterol 12 µg via a DPI with placebo via nebulizer at treatment visit 2. Placebo: The placebo used will be sterile, preservative free, normal saline for nebulizer inhalation and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current or past cigarette smoking history of >/= 10 pack-years.
- FEV1/FVC ratio </= 70%.
- Known diagnosis of COPD.
- Current hospitalization for a primary diagnosis of acute exacerbation of COPD.
- Must be able to understand and willing to sign an informed consent document.
Key exclusion criteria (12 listed)
- On a ventilator or mask ventilation.
- Allergy or contraindication to Formoterol use.
- Marked QTc prolongation (> 450 ms).
- Liver cirrhosis or chronic renal insufficiency (serum creatinine > 2 mg/dL).
- Atrial fibrillation with rapid ventricular response (heart rate > 110 bpm) or ventricular arrhythmia (frequent PVCs, ventricular tachycardia).
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 |
|---|---|---|
| FormoterolAlso: Foradil, PERFOROMISTComparison of dosage administered via a nebulizer versus dosage administered via a dry powder inhaler. 12 µg Formoterol with the dry powder inhaler and 20 µg (solution form) of Formoterol with the nebulizer. Patients will receive formoterol and placebo at both study visit #1 and visit #2. | Drug | Formoterol via DPI then Formoterol via nebulizer, Formoterol via nebulizer then Formoterol via DPI |
| PlaceboAlso: Normal SalineComparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2. | Other | Formoterol via DPI then Formoterol via nebulizer, Formoterol via nebulizer then Formoterol via DPI |
Primary outcome
The Difference Between the Values of Area Under the Response Curve for FEV1
Time frame: Baseline through study completion (visit 1 through visit 2)
The difference between the values of area under the response curve for FEV1 from baseline through four hours (AUC FEV1 0-4h) after inhalation of formoterol with a nebulizer or a dry powder inhaler.
8 secondary outcomes
Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol
Time frame: From pre-dose formoterol (baseline 0hrs) to 30 minutes, 1,2, and 4 hours post dose at visit 1 and measured again at visit 2
Absolute Increase in FEV1 From Baseline After Inhalation of Formoterol
Time frame: Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completed
Peak FEV1 Between the Two Devices (Nebulizer and DPI)
Time frame: Measured from Start of visit 1 until the completion of visit 2
Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol
Time frame: Baseline through study completion (visit 1 through visit 2)
Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol
Time frame: Measured at visit 1 and again at the end of visit 2
Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol
Time frame: Measured at visit 1 and again at the end of visit 2
Peak FVC Between the Two Devices (Nebulizer and DPI)
Time frame: Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change.
Change in Dyspnea Based on the Borg Dyspnea Scale for Shortness of Breath (Pre-dose Administration and 60 Minutes After Inhalation of Formoterol With a Nebulizer or a DPI)
Time frame: Measured at visit 1 and again at the end of visit 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rajiv Dhand, MD principal investigator
University of Tennessee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formoterol in people with COPD Exacerbation, run by University of Tennessee Graduate School of Medicine 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 5 inclusion and 12 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 19 Mar 2019. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Difference Between the Values of Area Under the Response Curve for FEV1 (time frame: Baseline through study completion (visit 1 through visit 2)). 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 19 Mar 2019.