Bronchodilators on the Exercise Capacity of Bronchiectasis Patients

NCT05183841 | Unknown DMC

• 1 other identifier: 3008.886
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Bronchiectasis Adult

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  60 seconds

Study Arms (3)

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.

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.

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.

Interventions

Bronchodilator (Ipratropium and Fenoterol) 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.

Also known as: duovent

Bronchodilator

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All sexes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (3)

Celso Ricardo Fernandes de Carvalho

São Paulo, 01246903, Brazil

Location

Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)

São Paulo, 05360000, Brazil

Location

Clinical Hospital of Sao Paulo University Medical School

São Paulo, 05360000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 40720815 DERIVED

MeSH Terms

Conditions

Bronchiectasis; Motor Activity

Interventions

Bronchodilator Agents; Ipratropium; Fenoterol; fenoterol, ipratropium drug combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Metaproterenol; Ethanolamines; Amino Alcohols; Alcohols; Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Celso RF Carvalho, PhD

  University of São Paulo General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All the measurements will be performed by a blinded professional, who will be masked from randomization and other results. The randomization sequence will be generated by computer, and put in sealed and opaque envelopes by a volunteer not involved in the study. The bronchodilator (BD) or placebo will be administered by a professional 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 11, 2022
• Study Start: April 14, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)