Inhaled A1AT in Adult Stable Bronchiectasis

NCT03383939 | Completed

• 1 other identifier: AC(HG) 44/95
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: to investigate the influence of alpha1-antitrypsin (A1-AT) nebulization on levels of A1-AT in BAL and plasma in patients with stable bronchiectasis. Method: single-blind placebo-controlled randomised clinical trial. 19 stable bronchiectasis patients with chronic bronchial infection and 10 control patients (without bronchiectasis) underwent a bronchoscopy in order to assess levels and inhibitory capacity of A1AT and neutrophilic elastase. Afterwards, the 19 bronchiectasis patients were randomly allocated to receive inhaled A1AT 250mg diluted in 10ml 0.9% saline solution once a day for a month (Group A, n: 10) or placebo (10ml 0.9% saline solution; group B, n: 9). A new BAL was performed in both groups (A and B) 24 hours after the end of treatment (1month) to re-analyze A1AT and NE.

Conditions

Bronchiectasis Adult

Keywords

bronchiectasis; alpha1-antitrypsin; neutrophilic elastase

Outcome Measures

Primary Outcomes (1)

• Changes from baseline BAL levels of A1AT

  Changes from baseline in levels of A1AT in broncho-alveolar lavage at 1 month of treatment with inhaled A1AT

  1 MONTH

Secondary Outcomes (2)

• Changes from baseline neutrophil elastase in BAL

  1 month

• Changes from baseline neutrophil elastase inhibitory capacity in BAL

  1 month

Study Arms (3)

group A

EXPERIMENTAL

10 patients randomly allocated received nebulised alpha1-antitrypsin 250mg (diluted in 10ml injectable solution) once a day during 1 month. Intervention: nebulised alpha1-antitrypsin 250mg (diluted in 10ml injectable solution) once a day during 1 month

Drug: Group A

group B

PLACEBO COMPARATOR

9 patients randomly allocated received 10ml 0.9%NaCl saline solution nebulised once daily during 1 month. intervention: 10ml 0.9% Sodium Chloride saline solution nebulised once daily during 1 month.

Drug: Group B

Control

NO INTERVENTION

10 patients without bronchiectasis were initially compared wiht bronchiectasis patients (group A + B) to define baseline levels of A1-AT and neutrophil elastase in BAL

Interventions

Group A DRUG

one nebulization with 250mg alpha-1-antitrypsine diluted in 10ml injectable solution once a day during 1 month. A CR-60 high flow compressor and Ventstream nebulizer were used for nebulization.

Also known as: inhaled Prolastin (nebulized alpha1-antitrypsin)

group A

Group B DRUG

10ml of 0.9% NaCl saline solution nebulised once daily for 1 month. A CR-60 high flow compressor and Ventstream nebulizer were used for nebulization.

Also known as: placebo

group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable clinical conditions (no use of systemic antibiotic or steroid treatment in the last month)
• diagnosis of bronchiectasis bt CT scan
• chronic purulent or mucopurulent expectoration (daily sputum expectoration in the last 6 months or more)

You may not qualify if:

• Cystic fibrosis
• interstitial lung disease as cause of bronchiectasis

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Bayer: collaborator
• Sociedad Española de Neumología y Cirugía Torácica: collaborator
• Instituto de Salud Carlos III: collaborator

MeSH Terms

Conditions

Bronchiectasis; alpha 1-Antitrypsin Deficiency

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Liver Diseases; Digestive System Diseases; Lung Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Subcutaneous Emphysema; Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier De Gracia, MD, PhD

  Servei de Pneumologia, Vall D'Hebron Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 parallel groups of patients with bronchictasis were investigated: 1 receiving inhaled prolastina and 1 receiving placebo (saline solution) all bronchiectasis patients were initially compared with 10 control patients with no bronchiectasis

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: December 27, 2017
• Study Start: June 1, 1996
• Primary Completion: September 7, 1999
• Study Completion: September 7, 1999
• Last Updated: December 27, 2017

Record last verified: 2017-12