BronchiectasisNCT05932316
Evaluating Bronchodilator Response in Patients With Bronchiectasis
A study testing spirometry and Salbutamol in people with Bronchiectasis and Cystic Fibrosis, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Although patients with bronchiectasis tend to have non reversible obstructive patterns on pulmonary function tests (PFTs), reversible obstruction is not uncommon. While bronchodilator response (BDR) is a main characteristic of asthma, the pathophysiology causing this phenomenon in bronchiectasis patients is less… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis, Cystic Fibrosis, Primary Ciliary Dyskinesia
- What is being tested?
- spirometry and Salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteIsrael
- Study dates
- 20 May 2023to Dec 2024
- Phase
- Interventional
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with bronchiectasis confirmed by CT scan
- No recent pulmonary exacerbation as determined by prescription of systemic antibiotics in 7 days prior to BDR testing
- No use of long-acting beta agonists (LABA) 12 hours before BDR testing or short acting beta agonist (SABA) 4 hours before testing
Who cannot join
- Patients under 5 years of age
- Patients incapable to perform proper spirometry
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Campus
Haifa, 3109601
Mordechai Pollak, MD, MSc, 0542388651, morduchp@gmail.com
About this study
Although patients with bronchiectasis tend to have non reversible obstructive patterns on pulmonary function tests (PFTs), reversible obstruction is not uncommon. While bronchodilator response (BDR) is a main characteristic of asthma, the pathophysiology causing this phenomenon in bronchiectasis patients is less clear.
The goal of this clinical trial is to assess BDR in patients with bronchiectasis.
Read more
The main aims of this study:
- To evaluate the role of bronchodilators in BDR testing of patients with bronchiectasis.
- Characterize and compare BDR between different subgroups of patients with bronchiectasis, and compared to patients without bronchiectasis (healthy controls).
- Identify demographics and other clinical variables associated with positive BDR
Participants will be taking a series of three spirometry tests: After the first spirometry testing, patients will be randomly assigned to receive bronchodilators as per bronchodilator response protocol (Salbutamol, 100 mcg, 4 puffs via spacer) or four puffs of placebo. After a waiting time of 15 minutes, spirometry will be repeated. Following the second spirometry testing those who received salbutamol will now receive placebo and those receiving placebo will receive Salbutamol. After a second period of 15 minutes, a third series of spirometry will be recorded.
Read the detailed description
Bronchiectasis are defined as irreversible dilatation of the bronchial tree. Patients with bronchiectasis suffer of chronic cough and sputum production, and are predisposed to recurrent airway infections. Many systemic diseases can cause bronchiectasis: cystic fibrosis (CF), primary ciliary dyskinesia (PCD), primary immune deficiencies (PID) and idiopathic bronchiectasis (IB) represent a significant proportion of patients with bronchiectasis starting in early age.
Pulmonary function testing (PFT) and specifically forced expiratory volume in one second (FEV1) is a common modality used to estimate lung disease progression and pulmonary exacerbations in patients with bronchiectasis. Although patients with bronchiectasis tend to have non reversible obstructive patterns on pulmonary function tests (PFTs), reversible obstruction is not uncommon. While bronchodilator response (BDR) is a main characteristic of asthma, the pathophysiology causing this phenomenon in bronchiectasis patients is less clear. The improvement in FEV1 after inhalation of bronchodilators can be attributed to bronchodilation or improved mucociliary clearance. It can be speculated that for some of the bronchiectasis patients, hyper-reactive airways or asthma can contribute to the reversible pattern. Despite the wide scale use of bronchodilators in bronchiectasis the evidence for its efficacy is lacking. While some studies found that BDR is associated with more severe disease, other studies did not find such associations.
According to ATS/ERS statement, the proper way to determine BDR, is by first recording three attempts of spirometry, then delivering bronchodilators, and after a waiting time, obtaining again at least three attempts of spirometry. The most resent ATS/ERS technical standard suggests that change of >10% relative to the predicted value for FEV1 or forced vital capacity (FVC) be considered a positive BDR.
While in most scenarios it is reasonable to assume that the change in FEV1 measured after the waiting time can be attributed solely to the affect of bronchodilators, this is not necessarily the case in bronchiectatic diseases. Theoretically, in bronchiectasis, the forced expiration maneuver used in spirometry testing can potentially cause changes in lung function, for example by inducing cough and mobilization of sputum. Evidence for this assumption can be seen in that respiratory therapy in terms if positive expiratory pressure (PEP) therapy can improve various parameters of lung function when tested again closely after the therapy.
The goal of this study is to determine if bronchodilator response in bronchiectatic disease might be influenced by other factors apart from the direct effect of bronchodilators. Secondary objectives are to assess if BDR is associated with age, gender, specific bronchiectatic disease, baseline FEV1, and other clinical factors such as sputum cultures, IgE levels, eosinophil levels, computed tomography (CT) score, family history of asthma and use of inhaled steroids.
- Conditions
- Bronchiectasis, Cystic Fibrosis, Primary Ciliary Dyskinesia, Primary Immune Deficiency, Bronchiolitis Obliterans
- Being tested
- spirometry, Salbutamol, placebo
- Keywords
- Bronchodilator response
- Medical subject headings
- Bronchiectasis, Cystic Fibrosis, Ciliary Motility Disorders, Primary Immunodeficiency Diseases, Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDiagnostic test
Also called pulmonary function testing
participants will undertake spirometry testing before and after bronchodilators and placebo
SalbutamolDrug
Also called bronchodilator
Salbutamol inhalation to determine bronchodilator response
placeboDrug
placebo inhalation prior to repeating spirometry
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol first | Other | Individuals included in this arm will receive 4 puffs of Salbutamol prior to the second set of spirometry testing, and 4 puffs of Placebo prior to the third set of spirometry. Receives: Diagnostic Test: spirometry; Drug: Salbutamol; Drug: placebo |
| Placebo First | Other | Individuals included in this arm will receive 4 puffs of placebo prior to the second set of spirometry testing and 4 puffs of Salbutamol prior to the third set of spirometry testing. Receives: Diagnostic Test: spirometry; Drug: Salbutamol; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchodilator response compared to placebo (change in FEV1)
Bronchodilator response = change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, compared to the same change after placebo. Results will be presented in "percent predicted" using global lung initiative (GLI) equations.
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response compared to placebo (change in FVC)
Bronchodilator response = change in forced vital capacity (FVC) from pre to post salbutamol inhalation, compared to the same change after placebo. Results will be presented in "percent predicted" using global lung initiative (GLI) equations.
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Secondary outcomes (10)
response in specific bronchiectatic disease
assessment of bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation) differences between different types of bronchiectatic disease (cystic fibrosis (CF), Primary ciliary dyskinesia (PCD), non CF - non PCD bronchiectatic disease) Results will be presented in "percent predicted" using global lung initiative (GLI) equations.
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
bronchiectasis compared to healthy controls
assessment of BDR (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation) differences between patients with bronchiectatic disease and healthy controls Results will be presented in "percent predicted" using global lung initiative (GLI) equations.
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by age
Identify if bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, presented in "percent predicted" using global lung initiative (GLI) equations) is influenced by the age of the participant
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by sex
Identify if bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, presented in "percent predicted" using global lung initiative (GLI) equations) is influenced by the biological sex of the participant
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by bronchiectatic disease
Identify if bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, presented in "percent predicted" using global lung initiative (GLI) equations) is influenced by the specific bronchiectatic disease (cystic fibrosis (CF), Primary ciliary dyskinesia (PCD), non CF - non PCD bronchiectatic disease).
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by use of inhaled steroids
Identify if bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, presented in "percent predicted" using global lung initiative (GLI) equations) is influenced by the use of inhaled corticosteroids.
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by history of allergy
Identify if bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, presented in "percent predicted" using global lung initiative (GLI) equations) is influenced by personal history of allergy
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by baseline FEV1
Identify if bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, presented in "percent predicted" using global lung initiative (GLI) equations) is influenced by baseline FEV1 as determined by the best FEV1 measured in the 6 months prior to the day of the study
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by history of pseudomonas
Identify if bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, presented in "percent predicted" using global lung initiative (GLI) equations) is influenced by personal history of pseudomonas growing in sputum cultures
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by bronchiectasis severity
Identify if bronchodilator response (change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, presented in "percent predicted" using global lung initiative (GLI) equations) is influenced by the severity of bronchiectasis as measured by CT imaging using the Bhalla score
Measured: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start20 May 2023
- Primary completionApr 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 BronchiectasisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each group of patients and controls will be randomly assigned to two study arms as follows: patients in both arms will perform regular spirometry. After the first series of spirometry testing, patients in the first arm will receive bronchodilators as per bronchodilator response protocol (Salbutamol, 100 mcg, 4 puffs via spacer) and patients in the second arm will receive four puffs of placebo. After a waiting time of 15 minutes, spirometry will be repeated. Following the second spirometry testing those who received salbutamol will now receive placebo and those receiving placebo will receive Salbutamol. After a second period of 15 minutes, a third series of spirometry will be recorded.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mordechai Pollak MD, MSc, Rambam Health Care Campus
- Investigators
- Mordechai Pollak, MD, MSc, Principal investigator, pediatric pulmonology institute, Ruth Rappaport children's hospital, Rambam medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932316
- Sponsor's protocol ID
- 0025-23-RMB
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Bronchodilator Response in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT05932316
- Acronym / sponsor ID
- 0025-23-RMB
- Conditions
- Bronchiectasis, Cystic Fibrosis, Primary Ciliary Dyskinesia, Primary Immune Deficiency, Bronchiolitis Obliterans
- Keywords
- Bronchodilator response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Jul 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.
Although patients with bronchiectasis tend to have non reversible obstructive patterns on pulmonary function tests (PFTs), reversible obstruction is not uncommon. While bronchodilator response (BDR) is a main characteristic of asthma, the pathophysiology causing this phenomenon in bronchiectasis patients is less clear.
The goal of this clinical trial is to assess BDR in patients with bronchiectasis.
The main aims of this study:
- To evaluate the role of bronchodilators in BDR testing of patients with bronchiectasis.
- Characterize and compare BDR between different subgroups of patients with bronchiectasis, and compared to patients without bronchiectasis (healthy controls).
- Identify demographics and other clinical variables associated with positive BDR
Participants will be taking a series of three spirometry tests: After the first spirometry testing, patients will be randomly assigned to receive bronchodilators as per bronchodilator response protocol (Salbutamol, 100 mcg, 4 puffs via spacer) or four puffs of placebo. After a waiting time of 15 minutes, spirometry will be repeated. Following the second spirometry testing those who received salbutamol will now receive placebo and those receiving placebo will receive Salbutamol. After a second period of 15 minutes, a third series of spirometry will be recorded.
Detailed description
Bronchiectasis are defined as irreversible dilatation of the bronchial tree. Patients with bronchiectasis suffer of chronic cough and sputum production, and are predisposed to recurrent airway infections. Many systemic diseases can cause bronchiectasis: cystic fibrosis (CF), primary ciliary dyskinesia (PCD), primary immune deficiencies (PID) and idiopathic bronchiectasis (IB) represent a significant proportion of patients with bronchiectasis starting in early age.
Pulmonary function testing (PFT) and specifically forced expiratory volume in one second (FEV1) is a common modality used to estimate lung disease progression and pulmonary exacerbations in patients with bronchiectasis. Although patients with bronchiectasis tend to have non reversible obstructive patterns on pulmonary function tests (PFTs), reversible obstruction is not uncommon. While bronchodilator response (BDR) is a main characteristic of asthma, the pathophysiology causing this phenomenon in bronchiectasis patients is less clear. The improvement in FEV1 after inhalation of bronchodilators can be attributed to bronchodilation or improved mucociliary clearance. It can be speculated that for some of the bronchiectasis patients, hyper-reactive airways or asthma can contribute to the reversible pattern. Despite the wide scale use of bronchodilators in bronchiectasis the evidence for its efficacy is lacking. While some studies found that BDR is associated with more severe disease, other studies did not find such associations.
According to ATS/ERS statement, the proper way to determine BDR, is by first recording three attempts of spirometry, then delivering bronchodilators, and after a waiting time, obtaining again at least three attempts of spirometry. The most resent ATS/ERS technical standard suggests that change of >10% relative to the predicted value for FEV1 or forced vital capacity (FVC) be considered a positive BDR.
While in most scenarios it is reasonable to assume that the change in FEV1 measured after the waiting time can be attributed solely to the affect of bronchodilators, this is not necessarily the case in bronchiectatic diseases. Theoretically, in bronchiectasis, the forced expiration maneuver used in spirometry testing can potentially cause changes in lung function, for example by inducing cough and mobilization of sputum. Evidence for this assumption can be seen in that respiratory therapy in terms if positive expiratory pressure (PEP) therapy can improve various parameters of lung function when tested again closely after the therapy.
The goal of this study is to determine if bronchodilator response in bronchiectatic disease might be influenced by other factors apart from the direct effect of bronchodilators. Secondary objectives are to assess if BDR is associated with age, gender, specific bronchiectatic disease, baseline FEV1, and other clinical factors such as sputum cultures, IgE levels, eosinophil levels, computed tomography (CT) score, family history of asthma and use of inhaled steroids.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Each group of patients and controls will be randomly assigned to two study arms as follows: patients in both arms will perform regular spirometry. After the first series of spirometry testing, patients in the first arm will receive bronchodilators as per bronchodilator response protocol (Salbutamol, 100 mcg, 4 puffs via spacer) and patients in the second arm will receive four puffs of placebo. After a waiting time of 15 minutes, spirometry will be repeated. Following the second spirometry testing those who received salbutamol will now receive placebo and those receiving placebo will receive Salbutamol. After a second period of 15 minutes, a third series of spirometry will be recorded.
| Arm | Type | Receives |
|---|---|---|
| Salbutamol first | Other | Diagnostic Test: spirometry, Drug: Salbutamol, Drug: placeboIndividuals included in this arm will receive 4 puffs of Salbutamol prior to the second set of spirometry testing, and 4 puffs of Placebo prior to the third set of spirometry. |
| Placebo First | Other | Diagnostic Test: spirometry, Drug: Salbutamol, Drug: placeboIndividuals included in this arm will receive 4 puffs of placebo prior to the second set of spirometry testing and 4 puffs of Salbutamol prior to the third set of spirometry testing. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with bronchiectasis confirmed by CT scan
- No recent pulmonary exacerbation as determined by prescription of systemic antibiotics in 7 days prior to BDR testing
- No use of long-acting beta agonists (LABA) 12 hours before BDR testing or short acting beta agonist (SABA) 4 hours before testing
Key exclusion criteria (2 listed)
- Patients under 5 years of age
- Patients incapable to perform proper spirometry
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 |
|---|---|---|
| spirometryAlso: pulmonary function testingparticipants will undertake spirometry testing before and after bronchodilators and placebo | Diagnostic test | Placebo First, Salbutamol first |
| SalbutamolAlso: bronchodilatorSalbutamol inhalation to determine bronchodilator response | Drug | Placebo First, Salbutamol first |
| placeboplacebo inhalation prior to repeating spirometry | Drug | Placebo First, Salbutamol first |
Primary outcome
Bronchodilator response compared to placebo (change in FEV1)
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response = change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, compared to the same change after placebo. Results will be presented in "percent predicted" using global lung initiative (GLI) equations.
Bronchodilator response compared to placebo (change in FVC)
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response = change in forced vital capacity (FVC) from pre to post salbutamol inhalation, compared to the same change after placebo. Results will be presented in "percent predicted" using global lung initiative (GLI) equations.
10 secondary outcomes
response in specific bronchiectatic disease
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
bronchiectasis compared to healthy controls
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by age
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by sex
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by bronchiectatic disease
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by use of inhaled steroids
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by history of allergy
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by baseline FEV1
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by history of pseudomonas
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Bronchodilator response by bronchiectasis severity
Time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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.
Mordechai Pollak, MD, MSc principal investigator
pediatric pulmonology institute, Ruth Rappaport children's hospital, Rambam 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 spirometry and Salbutamol in people with Bronchiectasis and Cystic Fibrosis, run by Rambam Health Care Campus at 1 site in Israel.
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 3 inclusion and 2 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 6 Jul 2023. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mordechai Pollak, MD, MSc (+972542388651, m_pollak@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bronchodilator response compared to placebo (change in FEV1) (time frame: spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)). The study lists 2 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 6 Jul 2023.