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Evaluating Bronchodilator Response in Patients With Bronchiectasis

NCT05932316 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2023-07-06

No results posted yet for this study

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 clear.

The goal of this clinical trial is to assess BDR in patients with bronchiectasis.

The main aims of this study:

1. To evaluate the role of bronchodilators in BDR testing of patients with bronchiectasis.
2. Characterize and compare BDR between different subgroups of patients with bronchiectasis, and compared to patients without bronchiectasis (healthy controls).
3. 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.

Conditions

Interventions

DIAGNOSTIC_TEST

spirometry

participants will undertake spirometry testing before and after bronchodilators and placebo

DRUG

Salbutamol

Salbutamol inhalation to determine bronchodilator response

DRUG

placebo

placebo inhalation prior to repeating spirometry

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Mordechai Pollak, MD, MSc · pediatric pulmonology institute, Ruth Rappaport children's hospital, Rambam medical center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-20
Primary Completion
2024-04-30
Completion
2024-12-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05932316 on ClinicalTrials.gov