Evaluating Bronchodilator Response in Patients With Bronchiectasis

NCT05932316 | Unknown

• 1 other identifier: 0025-23-RMB
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate the role of bronchodilators in BDR testing of patients with bronchiectasis.
2. 2.Characterize and compare BDR between different subgroups of patients with bronchiectasis, and compared to patients without bronchiectasis (healthy controls).
3. 3.Identify demographics and other clinical variables associated with positive BDR

Conditions

Bronchiectasis; Cystic Fibrosis; Primary Ciliary Dyskinesia; Primary Immune Deficiency; Bronchiolitis Obliterans

Keywords

Bronchodilator response

Outcome Measures

Primary Outcomes (2)

• Bronchodilator response compared to placebo (change in FEV1)

  Bronchodilator response = change in forced expiratory volume 1 second (FEV1) from pre to post salbutamol inhalation, compared to the same change after placebo. Results will be presented in "percent predicted" using global lung initiative (GLI) equations.

  spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)

• Bronchodilator response compared to placebo (change in FVC)

  Bronchodilator response = change in forced vital capacity (FVC) from pre to post salbutamol inhalation, compared to the same change after placebo. Results will be presented in "percent predicted" using global lung initiative (GLI) equations.

  spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)

Secondary Outcomes (10)

• response in specific bronchiectatic disease

  spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)

• bronchiectasis compared to healthy controls

  spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)

• Bronchodilator response by age

  spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)

• Bronchodilator response by sex

  spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)

• Bronchodilator response by bronchiectatic disease

  spirometry results will be collected in one clinic visit in three steps: *baseline *15 minutes after first intervention (placebo or salbutamol) *15 minutes after second intervention (placebo or salbutamol)

Study Arms (2)

Salbutamol first

OTHER

Individuals included in this arm will receive 4 puffs of Salbutamol prior to the second set of spirometry testing, and 4 puffs of Placebo prior to the third set of spirometry.

Diagnostic Test: spirometry; Drug: Salbutamol; Drug: placebo

Placebo First

OTHER

Individuals included in this arm will receive 4 puffs of placebo prior to the second set of spirometry testing and 4 puffs of Salbutamol prior to the third set of spirometry testing.

Diagnostic Test: spirometry; Drug: Salbutamol; Drug: placebo

Interventions

spirometry DIAGNOSTIC_TEST

participants will undertake spirometry testing before and after bronchodilators and placebo

Also known as: pulmonary function testing

Placebo First; Salbutamol first

Salbutamol DRUG

Salbutamol inhalation to determine bronchodilator response

Also known as: bronchodilator

Placebo First; Salbutamol first

placebo DRUG

placebo inhalation prior to repeating spirometry

Placebo First; Salbutamol first

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bronchiectasis confirmed by CT scan
• No recent pulmonary exacerbation as determined by prescription of systemic antibiotics in 7 days prior to BDR testing
• No use of long-acting beta agonists (LABA) 12 hours before BDR testing or short acting beta agonist (SABA) 4 hours before testing

You may not qualify if:

• Patients under 5 years of age
• Patients incapable to perform proper spirometry

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Campus

Haifa, 3109601, Israel

RECRUITING

MeSH Terms

Conditions

Bronchiectasis; Cystic Fibrosis; Ciliary Motility Disorders; Primary Immunodeficiency Diseases; Bronchiolitis Obliterans

Interventions

Spirometry; Respiratory Function Tests; Albuterol; Bronchodilator Agents

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Otorhinolaryngologic Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Bronchiolitis; Bronchitis; Lung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses

Study Officials

• Mordechai Pollak, MD, MSc

  pediatric pulmonology institute, Ruth Rappaport children's hospital, Rambam medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mordechai Pollak, MD, MSc

CONTACT

+972542388651; m_pollak@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Salbutamol inhaler and the placebo inhaler will be marked as '1' and '2'. The division Nurse will be in charge of marking the inhalers and all the rest of the team and participants will be blinded. The clinicians, technicians and patients will not be able to distinguish between Salbutamol and placebo, and will not know to what arm the patient was assigned at the time of the testing and the interpretation of the results.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mordechai Pollak

Model Details: Each group of patients and controls will be randomly assigned to two study arms as follows: patients in both arms will perform regular spirometry. After the first series of spirometry testing, patients in the first arm will receive bronchodilators as per bronchodilator response protocol (Salbutamol, 100 mcg, 4 puffs via spacer) and patients in the second arm will receive 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.

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 6, 2023
• Study Start: May 20, 2023
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)