Bronchodilators on the Exercise Capacity of Bronchiectasis Patients

NCT ID: NCT05183841

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2025-11-30

Brief 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. 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.

Conditions

Bronchiectasis Adult

Keywords

Bronchiectasis; Bronchodilators Agents; Exercise/Physical Activity; Respiratory Mechanics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bronchodilator (Ipratropium and Fenoterol)

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

8 puffs of placebo via an inhaler device with a spacer (30 seconds interval between puffs) in 5 tidal volume breaths each puff.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bronchodilator (Ipratropium and Fenoterol)

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.

Intervention Type: DRUG

Placebo

8 puffs of placebo via an inhaler device with a spacer (30 seconds interval between puffs) in 5 tidal volume breaths each puff.

Intervention Type: OTHER

Other Intervention Names

duovent

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Celso R. Carvalho

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Celso RF Carvalho, PhD

Role: STUDY_DIRECTOR

University of São Paulo General Hospital

Locations

Celso Ricardo Fernandes de Carvalho

São Paulo, , Brazil

Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)

São Paulo, , Brazil

Clinical Hospital of Sao Paulo University Medical School

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 40720815 (View on PubMed)

Other Identifiers

3008.886

Identifier Type: -

Identifier Source: org_study_id