Chronic Obstructive Pulmonary Disease ExacerbationPhase 3FUROSCOPENCT05769738
The Addition of Inhaled Furosemide to Standard Treatment of COPD Exacerbation
A Phase 3 study testing Furosemide and Normal saline in people with Chronic Obstructive Pulmonary Disease Exacerbation and COPD Exacerbation, run by American University of Beirut Medical Center.
Trial summary
The goal of this randomized controlled trial is to determine the effect of adding inhaled furosemide to the known treatment of patient with Chronic obstructive pulmonary disease (COPD) exacerbation. It primarily aims at studying its effect on: 1. Relief of dyspnea sensation 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Exacerbation, COPD Exacerbation
- What is being tested?
- Furosemide and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2024
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosed with COPD
- Presenting with COPD exacerbation
- Requiring hospitalization
Who cannot join
- Hemodynamically instability (systolic blood pressure ≤ 90mmHg, heart rate ≥ 120 or ≤ 50 Bpm)
- Decreased level of consciousness
- Non-invasive mechanical ventilation or intubation at the time of recruitment
- >5 liters of oxygen at the time of recruitment
- Pregnant patients
- Other primary pulmonary disease or heart failure exacerbation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Addition of Inhaled FUROsemide to Standard of Care in COPD Exacerbation: a Randomized Double Blinded Control Trial (FUROSCOPE Trial)
The goal of this randomized controlled trial is to determine the effect of adding inhaled furosemide to the known treatment of patient with Chronic obstructive pulmonary disease (COPD) exacerbation. It primarily aims at studying its effect on:
- Relief of dyspnea sensation
- Length of hospital stay
Participants will be receiving the standard therapy of COPD exacerbation plus either inhaled furosemide or inhaled saline over 3 days. They will be asked to:
- Perform spirometry
- Fill in dyspnea score
- Do arterial blood gases (ABGs)
- Being tested
- Furosemide, Normal saline
- Keywords
- COPD, furosemide, dyspnea, inhaled furosemide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Also called Lasix, Diuretic
40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days
Normal salineDrug
4ml of normal saline to be nebulized 3 times daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Furosemide group | Experimental | Inhaled furosemide Receives: Drug: Furosemide |
| Placebo group | Placebo comparator | Inhaled saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)
Visual analogue scale is a scale from 0 to 10, where 0 means no dyspnea at all and 10 is the worse dyspnea ever
Measured: at 24 hours
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)
Visual analogue scale is a scale from 0 to 10, where 0 means no dyspnea at all and 10 is the worse dyspnea ever
Measured: at 72 hours
Change in length of hospital stay
Measured: From admission to hospital discharge, up to 1 year
Secondary outcomes (8)
Change in lung volumes from baseline as measured by bedside spirometer
Forced expiratory volume in first second (FEV1) and forced vital capacity (FVC)
Measured: On days 0, 1 and 3
Change in Arterial blood gases
Measured: On days 0 and 1
Change in heart rate from baseline
Measured: On days 0, 1 and 3
Change in systolic and diastolic blood pressure from baseline
Measured: On days 0, 1 and 3
Change in steroid dose
Measured: Through hospital stay, up till 1 year
Change in the number of patients requiring intubation or non-invasive mechanical ventilation
Measured by questionnaire
Measured: Through hospital stay, up till 1 year
Change in mortality
Measured: Through hospital stay, up till 1 year
Number of patients with adverse events as documented by questionnaires
Including: kidney injury measured by Creatinine and urine output, electrolyte disturbances (sodium and potassium levels)
Measured: On days 1,2,3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nivine Abou Dargham, MD, Study director, AUBMCSalah Zeineddine, MD, Principal investigator, AUBMCHisham Bou Fakhreddine, MD, Principal investigator, AUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769738
- Sponsor's protocol ID
- BIO-2022-0187
- Acronym
- FUROSCOPE
- Status last verified
- Jan 2023
- First submitted
- 3 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of Inhaled FUROsemide to Standard of Care in COPD Exacerbation: a Randomized Double Blinded Control Trial (FUROSCOPE Trial)
- ClinicalTrials.gov ID
- NCT05769738
- Acronym / sponsor ID
- FUROSCOPE / BIO-2022-0187
- Keywords
- COPD, furosemide, dyspnea, inhaled furosemide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Mar 2023 (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 goal of this randomized controlled trial is to determine the effect of adding inhaled furosemide to the known treatment of patient with Chronic obstructive pulmonary disease (COPD) exacerbation. It primarily aims at studying its effect on:
- Relief of dyspnea sensation
- Length of hospital stay
Participants will be receiving the standard therapy of COPD exacerbation plus either inhaled furosemide or inhaled saline over 3 days. They will be asked to:
- Perform spirometry
- Fill in dyspnea score
- Do arterial blood gases (ABGs)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide group | Experimental | Drug: FurosemideInhaled furosemide |
| Placebo group | Placebo comparator | Drug: Normal salineInhaled saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosed with COPD
- Presenting with COPD exacerbation
- Requiring hospitalization
Key exclusion criteria (6 listed)
- Hemodynamically instability (systolic blood pressure ≤ 90mmHg, heart rate ≥ 120 or ≤ 50 Bpm)
- Decreased level of consciousness
- Non-invasive mechanical ventilation or intubation at the time of recruitment
- >5 liters of oxygen at the time of recruitment
- Pregnant patients
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 |
|---|---|---|
| FurosemideAlso: Lasix, Diuretic40mg (4ml) of furosemide to be nebulized 3 times daily for 3 days | Drug | Furosemide group |
| Normal saline4ml of normal saline to be nebulized 3 times daily for 3 days | Drug | Placebo group |
Primary outcome
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)
Time frame: at 24 hours
Visual analogue scale is a scale from 0 to 10, where 0 means no dyspnea at all and 10 is the worse dyspnea ever
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS)
Time frame: at 72 hours
Visual analogue scale is a scale from 0 to 10, where 0 means no dyspnea at all and 10 is the worse dyspnea ever
Change in length of hospital stay
Time frame: From admission to hospital discharge, up to 1 year
8 secondary outcomes
Change in lung volumes from baseline as measured by bedside spirometer
Time frame: On days 0, 1 and 3
Change in Arterial blood gases
Time frame: On days 0 and 1
Change in heart rate from baseline
Time frame: On days 0, 1 and 3
Change in systolic and diastolic blood pressure from baseline
Time frame: On days 0, 1 and 3
Change in steroid dose
Time frame: Through hospital stay, up till 1 year
Change in the number of patients requiring intubation or non-invasive mechanical ventilation
Time frame: Through hospital stay, up till 1 year
Change in mortality
Time frame: Through hospital stay, up till 1 year
Number of patients with adverse events as documented by questionnaires
Time frame: On days 1,2,3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Nivine Abou Dargham, MD study director
AUBMC
Salah Zeineddine, MD principal investigator
AUBMC
Hisham Bou Fakhreddine, MD principal investigator
AUBMC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide and Normal saline in people with Chronic Obstructive Pulmonary Disease Exacerbation and COPD Exacerbation, run by American University of Beirut Medical Center.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nivine Abou Dargham, MD (0096170160343, na291@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dyspnea score from baseline as assessed by visual analogue scale (VAS) (time frame: at 24 hours). The study lists 3 primary outcomes in all. 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 15 Mar 2023.