- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05183841
Bronchodilators on the Exercise Capacity of Bronchiectasis Patients
December 4, 2023 updated by: Celso R. Carvalho, University of Sao Paulo General Hospital
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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São Paulo, Brazil, 01246903
- Celso Ricardo Fernandes de Carvalho
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São Paulo, Brazil, 05360000
- Clinical Hospital of São Paulo University medical school (HCFMUSP)
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São Paulo, Brazil, 05360000
- Clinical Hospital of Sao Paulo University Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Do not accept to participate
- Smoking
- Continuous oxygen use
- Pulmonary Rehabilitation program in the last 6 months
- Previous lung resection
- Uncontrolled cardiovascular disease
- Other respiratory chronic diseases
- Neurological or musculoskeletal disorders that limit exercise
- Cognitive deficits that limit comprehension
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bronchodilator
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.
|
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.
Other Names:
|
Placebo Comparator: Placebo
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.
|
8 puffs of placebo via an inhaler device with a spacer (30 seconds interval between puffs) in 5 tidal volume breaths each puff.
Other Names:
|
No Intervention: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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60 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Celso RF Carvalho, PhD, University of Sao Paulo General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2022
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
December 21, 2021
First Submitted That Met QC Criteria
January 7, 2022
First Posted (Actual)
January 11, 2022
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Bronchial Diseases
- Bronchiectasis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Adrenergic Agonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Reproductive Control Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Tocolytic Agents
- Sympathomimetics
- Ipratropium
- Bronchodilator Agents
- Fenoterol
Other Study ID Numbers
- 3008.886
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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