Bronchiectasis AdultNCT03383939
Inhaled A1AT in Adult Stable Bronchiectasis
A study testing Group A and Group B in people with Bronchiectasis Adult, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Group A and Group B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 1996to 7 Sep 1999
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Cystic fibrosis
- interstitial lung disease as cause of bronchiectasis
About this study
Official title: Effects of Inhaled Alpha-1-anti-trypsin on Proteolytic Activity in BAL of Bronchiectasis Patients With Chronic Bronchial Expectoration
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.
Read the detailed description
Effects of inhaled alpha-1-anti-trypsin in bronchiectasis patients with chronic bronchial infection.
Introduction: one of the main features of bronchiectasis is chronic and deregulated neutrophilic bronchial inflammation. Excessive neutrophilic elastase (NE) activity has been widely described as part of the characteristic imbalance between proteases and anti-proteolytic enzymes that characterizes airways inflammation and progressive lung damage in bronchiectasis.
Alpha-1-antitrypsin (A1AT) is a protease inhibitor involved in protecting lung tissue from enzymes of inflammatory cells, including neutrophilic elastase, and its concentration rises in case of acute and chronic inflammation. Its reduction or absence is associated with the development of a specific kind of emphysema in case of exposure to tobacco smoking.
Moreover it is likely that its levels could be reduced in bronchiectasis as a consequence of chronic bronchial infection and inflammatory deregulation.
Aims:
- concentrations of total and free NE, NE inhibitory capacity and A1AT levels were investigated in broncho-alveolar lavage (BAL) of bronchiectasis patients with chronic airways infection in stable conditions in comparison with a control group (patients without bronchiectasis)
- The effects of inhaled A1AT (Prolastin) on BAL concentration of total and free NE and A1AT and inhibitory capacity of NE were assessed after one month of treatment in patients with bronchiectasis and chronic bronchial infection (placebo controlled trial) Study design: simple blind placebo-controlled randomized clinical trial
Methods:
19 patients with stable non cystic fibrosis bronchiectasis and chronic bronchial infection and 10 patients without bronchiectasis (control group) underwent a bronchoscopy to perform BAL analysis.
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.
Clinical, microbiological, biochemical, functional and radiological characteristics of bronchiectasis and potential side effects of treatment on both arms were also recorded before (baseline), at 7, 15, 30 days of treatment and at 1 and 2 months follow-up visits after the end of treatment. The trial was approved by Spanish Ministry of Health (Trial nº 95/256) and local Ethics Committee (AC(HG) 44/95) and all patients signed written consent.
- Conditions
- Bronchiectasis Adult
- Being tested
- Group A, Group B
- Keywords
- bronchiectasis, alpha1-antitrypsin, neutrophilic elastase
- Medical subject headings
- Bronchiectasis, alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADrug
Also called inhaled Prolastin (nebulized alpha1-antitrypsin)
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.
Group BDrug
Also called placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 MONTH
Secondary outcomes (2)
Changes from baseline neutrophil elastase in BAL
Changes from baseline in levels of neutrophil elastase in broncho-alveolar lavage at 1 month of treatment with inhaled A1AT
Measured: 1 month
Changes from baseline neutrophil elastase inhibitory capacity in BAL
Changes from baseline in levels of neutrophil elastase inhibitory capacity in broncho-alveolar lavage at 1 month of treatment with inhaled A1AT
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2017
- Study start1 Jun 1996
- Primary completion7 Sep 1999
- Study completion7 Sep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Sociedad Española de Neumología y Cirugía Torácica, Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- Javier De Gracia, MD, PhD, Principal investigator, Servei de Pneumologia, Vall D'Hebron Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383939
- Sponsor's protocol ID
- AC(HG) 44/95
- Status last verified
- Dec 2017
- First submitted
- 27 Sep 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inhaled Alpha-1-anti-trypsin on Proteolytic Activity in BAL of Bronchiectasis Patients With Chronic Bronchial Expectoration
- ClinicalTrials.gov ID
- NCT03383939
- Acronym / sponsor ID
- AC(HG) 44/95
- Conditions
- Bronchiectasis Adult
- Keywords
- bronchiectasis, alpha1-antitrypsin, neutrophilic elastase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Bayer, Sociedad Española de Neumología y Cirugía Torácica, Instituto de Salud Carlos III
- Study start
- 1 Jun 1996 (actual)
- Primary completion
- 7 Sep 1999 (actual)
- Study completion
- 7 Sep 1999 (actual)
- First posted
- 27 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Effects of inhaled alpha-1-anti-trypsin in bronchiectasis patients with chronic bronchial infection.
Introduction: one of the main features of bronchiectasis is chronic and deregulated neutrophilic bronchial inflammation. Excessive neutrophilic elastase (NE) activity has been widely described as part of the characteristic imbalance between proteases and anti-proteolytic enzymes that characterizes airways inflammation and progressive lung damage in bronchiectasis.
Alpha-1-antitrypsin (A1AT) is a protease inhibitor involved in protecting lung tissue from enzymes of inflammatory cells, including neutrophilic elastase, and its concentration rises in case of acute and chronic inflammation. Its reduction or absence is associated with the development of a specific kind of emphysema in case of exposure to tobacco smoking.
Moreover it is likely that its levels could be reduced in bronchiectasis as a consequence of chronic bronchial infection and inflammatory deregulation.
Aims:
- concentrations of total and free NE, NE inhibitory capacity and A1AT levels were investigated in broncho-alveolar lavage (BAL) of bronchiectasis patients with chronic airways infection in stable conditions in comparison with a control group (patients without bronchiectasis)
- The effects of inhaled A1AT (Prolastin) on BAL concentration of total and free NE and A1AT and inhibitory capacity of NE were assessed after one month of treatment in patients with bronchiectasis and chronic bronchial infection (placebo controlled trial) Study design: simple blind placebo-controlled randomized clinical trial
Methods:
19 patients with stable non cystic fibrosis bronchiectasis and chronic bronchial infection and 10 patients without bronchiectasis (control group) underwent a bronchoscopy to perform BAL analysis.
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.
Clinical, microbiological, biochemical, functional and radiological characteristics of bronchiectasis and potential side effects of treatment on both arms were also recorded before (baseline), at 7, 15, 30 days of treatment and at 1 and 2 months follow-up visits after the end of treatment. The trial was approved by Spanish Ministry of Health (Trial nº 95/256) and local Ethics Committee (AC(HG) 44/95) and all patients signed written consent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: Group A10 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 |
| group B | Placebo comparator | Drug: Group B9 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. |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Cystic fibrosis
- interstitial lung disease as cause of bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AAlso: inhaled Prolastin (nebulized alpha1-antitrypsin)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. | Drug | group A |
| Group BAlso: placebo10ml 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. | Drug | group B |
Primary outcome
Changes from baseline BAL levels of A1AT
Time frame: 1 MONTH
Changes from baseline in levels of A1AT in broncho-alveolar lavage at 1 month of treatment with inhaled A1AT
2 secondary outcomes
Changes from baseline neutrophil elastase in BAL
Time frame: 1 month
Changes from baseline neutrophil elastase inhibitory capacity in BAL
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier De Gracia, MD, PhD principal investigator
Servei de Pneumologia, Vall D'Hebron Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Bronchiectasis Adult, run by Hospital Universitari Vall d'Hebron Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline BAL levels of A1AT (time frame: 1 MONTH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.