Bronchiectasis AdultNCT05183841
Bronchodilators on the Exercise Capacity of Bronchiectasis Patients
A study testing Bronchodilator (Ipratropium and Fenoterol) in people with Bronchiectasis Adult, run by University of Sao Paulo General Hospital at 3 sites in Brazil.
Trial summary
The bronchodilators (BD) have been widely used in bronchiectasis (BCE) therapeutic and have been shown to be effective in improving exercise capacity in patients with chronic obstructive pulmonary disease and asthma. However the BD effect on the exercise capacity of patients with BCE is poorly known. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Bronchodilator (Ipratropium and Fenoterol)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesBrazil
- Study dates
- 14 Apr 2022to Nov 2025
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All sexes
- 18 to 59 years
- Bronchiectasis diagnosis, according to thorax the Computed Tomography (Pasteur et al., 2010)
- Clinically stable (last 30 days without exacerbation/hospitalization)
- Air trapping on plethysmography (Residual Volume/Total Lung Capacity>125%)
- Smoking Load <10 pack-years
Who cannot join
- Do not accept to participate
- Smoking
- Continuous oxygen use
- Pulmonary Rehabilitation program in the last 6 months
- Previous lung resection
- Uncontrolled cardiovascular disease
Show all 9Show fewer
- Other respiratory chronic diseases
- Neurological or musculoskeletal disorders that limit exercise
- Cognitive deficits that limit comprehension
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Celso Ricardo Fernandes de Carvalho
São Paulo, 01246903
Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)
São Paulo, 05360000
Clinical Hospital of Sao Paulo University Medical School
São Paulo, 05360000
About this study
Official title: Effect of Bronchodilators on the Exercise Capacity of Bronchiectasis Patients
The bronchodilators (BD) have been widely used in bronchiectasis (BCE) therapeutic and have been shown to be effective in improving exercise capacity in patients with chronic obstructive pulmonary disease and asthma. However the BD effect on the exercise capacity of patients with BCE is poorly known. Besides, the respiratory mechanics pattern of the patients with BCE is not known nor its association with their physical activity level (PAL). Therefore, the hypothesis of this study is that BD are effective in improving exercise capacity of patients with BCE. The authors also propose to characterize the respiratory mechanics of the patients with BCE and to evaluate their PAL and its association with quality of life, as secondary aims.
Read the detailed description
This is a randomized, double-blind, crossover, placebo-controlled trial. Forty clinically stable patients with bronchiectasis (BCE), all sexes, 18 to 59 years, will be evaluated in two non-consecutive days. On the first day, anamnesis, anthropometric evaluation and lung function will be performed, followed by: Quality of Life Questionnaire-Bronchiectasis, Saint George questionnaire, modified Medical Research Council scale and social and economic status. Then, a cardiopulmonary exercise test (CPET) will be performed and after a rest period, a bronchodilator (BD) or placebo randomization will precede a constant load exercise test (CLET) with the respiratory mechanics assessment (OEP). Spirometry will be performed pre and post BD/placebo. Finally, the accelerometer will be coupled to the patient for 7 consecutive days, aiming to assess the PAL. On the second day, after at least one-week washout, the accelerometer will be collected and the patient will repeat the CLET with the respiratory mechanics assessment, at the opposite condition to the randomization. The randomization sequence will be generated by computer, and put in sealed and opaque envelopes by a volunteer not involved in the study. The BD or placebo will be administered by a volunteer not involved in the study, according to the randomization. The evaluator will not have access to information on which intervention (BD or placebo) was given prior to each CLET. A paired (anthropometric and social and economic status) healthy control group will be assessed by spirometry, CPET, and CLET and OEP, for comparing respiratory mechanics. In addition the participants will also use an accelerometer for 7 consecutive days. Data of endurance time from CLET, respiratory mechanics from OEP, dyspnea and vital signs will be assessed before and after both BD and placebo CLET. Data about onset of BCE, comorbidities and BCE medication will be collected from the patient's medical record. Data normality will be tested by Kolmogorov-Smirnov. Data comparison will be performed by t test or Wilcoxon and the association by Pearson or Spearman. Categorical data will be analyzed by qui-square test or Fischer. The significance level will be set to 5% for all tests.
- Conditions
- Bronchiectasis Adult
- Being tested
- Bronchodilator (Ipratropium and Fenoterol), Placebo
- Keywords
- Bronchiectasis, Bronchodilators Agents, Exercise/Physical Activity, Respiratory Mechanics
- Medical subject headings
- Bronchiectasis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchodilator (Ipratropium and Fenoterol)Drug
Also called duovent
8 puffs of Ipratropium (20mcg) and Fenoterol (50mcg) via an inhaler device with a spacer (30 seconds interval between puffs) in 5 tidal volume breaths each puff.
PlaceboOther
8 puffs of placebo via an inhaler device with a spacer (30 seconds interval between puffs) in 5 tidal volume breaths each puff.
| Study group | Role | What they receive |
|---|---|---|
| Bronchodilator | Active comparator | The intervention will be a combination of 2 drugs, ipratropium (20 mcg) and fenoterol (50mcg). Ipratropium is an anticholinergic bronchodilator, and fenoterol is a beta-agonist bronchodilator. The medication will be delivered to the patient via an inhaler device with spacer, at leat 20 minutes before the constant load exercise test (CLET). Patient will be asked for a total exhalation, followed by an appropriate spacer mouthpiece placement and the first of eight puffs (30 seconds interval between puffs) will be delivered through the opposite extremity of the spacer. Patient will be instructed to perform five tidal volume breaths for each puff. Receives: Drug: Bronchodilator (Ipratropium and Fenoterol) |
| Placebo | Placebo comparator | The placebo will be delivered via an inhaler device with spacer (identical to the bronchodilator device), at least 20 minutes before the constant load exercise test (CLET). Patient will be asked for a total exhalation, followed by an appropriate spacer mouthpiece placement and the first of eight puffs (30 seconds interval between puffs) will be delivered through the opposite extremity of the spacer. Patient will be instructed to perform five tidal volume breaths for each puff. Receives: Other: Placebo |
| Control | No intervention | A paired healthy control group will be assessed by a constant load exercise test (75% from maximal load achieved on the cardiopulmonary exercise test) concomitant to the optoelectronic plethysmography to compare mechanical respiratory parameters to the bronchiectasis patients during the placebo assessment. In addition they will also use an accelerometer for 7 consecutive days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
endurance time
Endurance time will be assessed by the constant load exercise test (CLET). The CLET will be performed with 75% of maximal load (W) achieved on the cardiopulmonary exercise test (CPET). The CLET will be performed at a cycloergometer and the end of the CLET will be determined by the exertion (modified Borg Scale 9-10) or the required pedaling rate (60/min.) could not be kept up for 10 seconds.
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start14 Apr 2022
- Primary completionNov 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Model description
- On the first day, anamnesis, anthropometric evaluation and lung function will be performed, followed by: Quality of Life Questionnaire-Bronchiectasis, Saint George questionnaire, modified Medical Research Council scale and social and economic status. Then, a cardiopulmonary exercise test (CPET) will be performed and after rest, a bronchodilator (BD) or placebo randomization will precede a constant load exercise test (CLET) with the respiratory mechanics assessment (OEP). Finally, the accelerometer will be coupled to the patient for 7 consecutive days, aiming to assess the PAL. On the second day, after at least one-week washout, the accelerometer will be collected and the patient will repeat the CLET with the respiratory mechanics assessment, at the opposite condition to randomization.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celso R. Carvalho, University of Sao Paulo General Hospital
- Investigators
- Celso RF Carvalho, PhD, Study director, University of São Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183841
- Sponsor's protocol ID
- 3008.886
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marques da Silva CCB, Dal Corso S, Lunardi AC, Fonseca AJ, Rached SZ, Athanazio RA, Carvalho CRF. Effect of Dual Bronchodilation on the Exercise Capacity of Individuals With Non-Cystic Fibrosis Bronchiectasis: Protocol for a Randomized Controlled Double-Blind Crossover Study. JMIR Res Protoc. 2025 Jul 28;14:e68582. doi: 10.2196/68582.
PubMed 40720815
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bronchodilators on the Exercise Capacity of Bronchiectasis Patients
- ClinicalTrials.gov ID
- NCT05183841
- Acronym / sponsor ID
- 3008.886
- Conditions
- Bronchiectasis Adult
- Keywords
- Bronchiectasis, Bronchodilators Agents, Exercise/Physical Activity, Respiratory Mechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Jan 2022 (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 bronchodilators (BD) have been widely used in bronchiectasis (BCE) therapeutic and have been shown to be effective in improving exercise capacity in patients with chronic obstructive pulmonary disease and asthma. However the BD effect on the exercise capacity of patients with BCE is poorly known. Besides, the respiratory mechanics pattern of the patients with BCE is not known nor its association with their physical activity level (PAL). Therefore, the hypothesis of this study is that BD are effective in improving exercise capacity of patients with BCE. The authors also propose to characterize the respiratory mechanics of the patients with BCE and to evaluate their PAL and its association with quality of life, as secondary aims.
Detailed description
This is a randomized, double-blind, crossover, placebo-controlled trial. Forty clinically stable patients with bronchiectasis (BCE), all sexes, 18 to 59 years, will be evaluated in two non-consecutive days. On the first day, anamnesis, anthropometric evaluation and lung function will be performed, followed by: Quality of Life Questionnaire-Bronchiectasis, Saint George questionnaire, modified Medical Research Council scale and social and economic status. Then, a cardiopulmonary exercise test (CPET) will be performed and after a rest period, a bronchodilator (BD) or placebo randomization will precede a constant load exercise test (CLET) with the respiratory mechanics assessment (OEP). Spirometry will be performed pre and post BD/placebo. Finally, the accelerometer will be coupled to the patient for 7 consecutive days, aiming to assess the PAL. On the second day, after at least one-week washout, the accelerometer will be collected and the patient will repeat the CLET with the respiratory mechanics assessment, at the opposite condition to the randomization. The randomization sequence will be generated by computer, and put in sealed and opaque envelopes by a volunteer not involved in the study. The BD or placebo will be administered by a volunteer not involved in the study, according to the randomization. The evaluator will not have access to information on which intervention (BD or placebo) was given prior to each CLET. A paired (anthropometric and social and economic status) healthy control group will be assessed by spirometry, CPET, and CLET and OEP, for comparing respiratory mechanics. In addition the participants will also use an accelerometer for 7 consecutive days. Data of endurance time from CLET, respiratory mechanics from OEP, dyspnea and vital signs will be assessed before and after both BD and placebo CLET. Data about onset of BCE, comorbidities and BCE medication will be collected from the patient's medical record. Data normality will be tested by Kolmogorov-Smirnov. Data comparison will be performed by t test or Wilcoxon and the association by Pearson or Spearman. Categorical data will be analyzed by qui-square test or Fischer. The significance level will be set to 5% for all tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- On the first day, anamnesis, anthropometric evaluation and lung function will be performed, followed by: Quality of Life Questionnaire-Bronchiectasis, Saint George questionnaire, modified Medical Research Council scale and social and economic status. Then, a cardiopulmonary exercise test (CPET) will be performed and after rest, a bronchodilator (BD) or placebo randomization will precede a constant load exercise test (CLET) with the respiratory mechanics assessment (OEP). Finally, the accelerometer will be coupled to the patient for 7 consecutive days, aiming to assess the PAL. On the second day, after at least one-week washout, the accelerometer will be collected and the patient will repeat the CLET with the respiratory mechanics assessment, at the opposite condition to randomization.
| Arm | Type | Receives |
|---|---|---|
| Bronchodilator | Active comparator | Drug: Bronchodilator (Ipratropium and Fenoterol)The intervention will be a combination of 2 drugs, ipratropium (20 mcg) and fenoterol (50mcg). Ipratropium is an anticholinergic bronchodilator, and fenoterol is a beta-agonist bronchodilator. The medication will be delivered to the patient via an inhaler device with spacer, at leat 20 minutes before the constant load exercise test (CLET). Patient will be asked for a total exhalation, followed by an appropriate spacer mouthpiece placement and the first of eight puffs (30 seconds interval between puffs) will be delivered through the opposite extremity of the spacer. Patient will be instructed to perform five tidal volume breaths for each puff. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo will be delivered via an inhaler device with spacer (identical to the bronchodilator device), at least 20 minutes before the constant load exercise test (CLET). Patient will be asked for a total exhalation, followed by an appropriate spacer mouthpiece placement and the first of eight puffs (30 seconds interval between puffs) will be delivered through the opposite extremity of the spacer. Patient will be instructed to perform five tidal volume breaths for each puff. |
| Control | No intervention | –A paired healthy control group will be assessed by a constant load exercise test (75% from maximal load achieved on the cardiopulmonary exercise test) concomitant to the optoelectronic plethysmography to compare mechanical respiratory parameters to the bronchiectasis patients during the placebo assessment. In addition they will also use an accelerometer for 7 consecutive days. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All sexes
- 18 to 59 years
- Bronchiectasis diagnosis, according to thorax the Computed Tomography (Pasteur et al., 2010)
- Clinically stable (last 30 days without exacerbation/hospitalization)
- Air trapping on plethysmography (Residual Volume/Total Lung Capacity>125%)
Key exclusion criteria (9 listed)
- Do not accept to participate
- Smoking
- Continuous oxygen use
- Pulmonary Rehabilitation program in the last 6 months
- Previous lung resection
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 |
|---|---|---|
| Bronchodilator (Ipratropium and Fenoterol)Also: duovent8 puffs of Ipratropium (20mcg) and Fenoterol (50mcg) via an inhaler device with a spacer (30 seconds interval between puffs) in 5 tidal volume breaths each puff. | Drug | Bronchodilator |
| Placebo8 puffs of placebo via an inhaler device with a spacer (30 seconds interval between puffs) in 5 tidal volume breaths each puff. | Other | Placebo |
Primary outcome
endurance time
Time frame: 60 seconds
Endurance time will be assessed by the constant load exercise test (CLET). The CLET will be performed with 75% of maximal load (W) achieved on the cardiopulmonary exercise test (CPET). The CLET will be performed at a cycloergometer and the end of the CLET will be determined by the exertion (modified Borg Scale 9-10) or the required pedaling rate (60/min.) could not be kept up for 10 seconds.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 40720815Marques da Silva CCB, Dal Corso S, Lunardi AC, Fonseca AJ, Rached SZ, Athanazio RA, Carvalho CRF. Effect of Dual Bronchodilation on the Exercise Capacity of Individuals With Non-Cystic Fibrosis Bronchiectasis: Protocol for a Randomized Controlled Double-Blind Crossover Study. JMIR Res Protoc. 2025 Jul 28;14:e68582. doi: 10.2196/68582.
- Individual participant dataSharing planned: No
Related trials for Bronchiectasis Adult
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
RecruitingPhase 2
Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB)
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingPhase 1
A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa
Healthy Participants, Non-cystic Fibrosis Bronchiectasis
RecruitingPhase 4
Azithromycin to Modify Bronchiectasis Exacerbation Risk
Non-cystic Fibrosis Bronchiectasis, Bronchiectasis Adult
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.
Celso RF Carvalho, PhD study director
University of São Paulo General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchodilator (Ipratropium and Fenoterol) in people with Bronchiectasis Adult, run by University of Sao Paulo General Hospital at 3 sites in Brazil.
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 9 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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. 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.
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?
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?
endurance time (time frame: 60 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183841, which also lists 1 linked publication.
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 11 Dec 2023.