Alpha-1 Antitrypsin Deficiency (AATD)RRALFA1NCT07242079
Effect Of Pulmonary Rehabilitation in Patients With Alpha-1 Antitrypsin Deficiency
An observational study of Alpha-1 Antitrypsin Deficiency (AATD), run by University of Parma at 1 site in Italy.
Trial summary
This single-center, longitudinal, observational, prospective study aims to assess the applicability, adherence, and clinical impact of the Active Cycle of Breathing Technique (ACBT) with augmented reality support in patients with alpha-1 antitrypsin deficiency (AATD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alpha-1 Antitrypsin Deficiency (AATD)
- What is being tested?
- Pulmonary Rehabilitation
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2024to 24 Jun 2025
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will consist of 50 adult patients, referred at outpatient clinic of the Respiratory Disease Unit of the University Hospital of Parma (Italy)
Who may be able to join
- Male or female adults aged ≥18 years;
- Signed informed consent;
- All AATD patients, regardless of nephelometric alpha-1 antitrypsin dose and clinical phenotype, who require PR according to guidelines
Who cannot join
- Subjects unable to perform the lung function tests and rehabilitation program required by the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pulmonary Rehabilitation and Physical Activity in Patients With Alpha-1 Antitrypsin Deficiency
This single-center, longitudinal, observational, prospective study aims to assess the applicability, adherence, and clinical impact of the Active Cycle of Breathing Technique (ACBT) with augmented reality support in patients with alpha-1 antitrypsin deficiency (AATD).
A total of 50 adult AATD patients will be recruit from the Lung Function Unit of the University Hospital of Parma, meeting specific inclusion criteria. Participants will perform ACBT twice daily and walk at least 5000 steps per day. Clinical and functional outcomes including dyspnea perception, lung function, and quality of life, will be assessed before and after a six-week ACBT program.
The study explores whether augmented reality enhance adherence and efficacy compared to conventional pulmonary rehabilitation (PR) methods. The expected outcome is improved adherence to PR.
Read the detailed description
Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder caused by mutations in the SERPINA1 gene, located on chromosome 14. The condition is characterized by low circulating levels of alpha-1 antitrypsin (AAT), a glycoprotein primarily produced by hepatocytes, which plays a crucial role in inhibiting neutrophil elastase (NE). Without adequate AAT, unregulated NE activity damages the lung parenchyma, leading to progressive emphysema. AATD presents with variable phenotypic expression, ranging from asymptomatic individuals to those with severe pulmonary and hepatic complications.
Treatment includes intravenous AAT replacement therapy, vaccination and guideline-recommended pulmonary rehabilitation (PR) based on the patient's clinical condition.
PR consists of a structured program combining breathing exercises, physical training, education, and psychological support to optimize respiratory function and improve patients' quality of life. One of the most effective techniques within PR is the Active Cycle of Breathing Technique (ACBT), which enhances airway clearance and lung function. ACBT is a simple, standardized, and home-based technique that patients can perform with or without digital tools. ACBT has already been shown to improve forced vital capacity, peak expiratory flow, arterial oxygenation and exercise capacity.
A tendency towards poor adherence to PR has been reported in the literature. To facilitate the performance of PR procedures, technological evolution in recent decades has brought new complementary techniques such as active video games, virtual reality and augmented reality.
ThIs study aims to assess satisfaction, adherence, and usability of pulmonary rehabilitation techniques in AATD patients, both with and without technological support, through relevant questionnaires (VAS, RAI, USE, TAM). Additionally, it aims to describe changes in the perception of dyspnea (mMRC), quality of life (EuroQol 5), impact of the pathology on daily life, and some functional parameters (FEV1, FVC, R5-R20, LCI, metres walked assessed by the six-minute walking test) at baseline and at the end of the rehabilitation program.
Data will be collected in a dedicated electronic Clinical Records Form (CRF). The database will be saved on a password-protected company Personal Computer (PC) which will be updated at each visit and used exclusively for scientific research purposes. At the time of enrollment, each patient will receive an alphanumeric code so that any information collected during the study, and in particular sensitive data, is treated in an anonymous manner. Data reporting patients' identifications will only be used to file patients and collect informed consent.
- Conditions
- Alpha-1 Antitrypsin Deficiency (AATD)
- Being tested
- Pulmonary Rehabilitation
- Keywords
- Alpha-1 antitrypsin deficiency, Pulmonary rehabilitation, Active Cycle of Breathing Technique
- Medical subject headings
- alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
the Active Cycle of Breathing Technique (ACBT) is a simple, standardized, and home-based technique that patients can perform with or without digital tools. ACBT has already been shown to improve forced vital capacity, peak expiratory flow, arterial oxygenation and exercise capacity.
| Study group | Role | What they receive |
|---|---|---|
| Patients with alpha-1 antitrypsin deficiency (AATD) | Adults with a confirmed diagnosis of alpha-1 antitrypsin deficiency (AATD) with asthma and/or COPD. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with PR techniques using Technology Acceptance Model (TAM) questionnaire.
Satisfaction will be assessed using the Technology Acceptance Model (TAM) questionnaire, with scores ranging from 1 to 7, where lower scores indicate more satisfaction.
Measured: six weeks
Patient adherence to the PR techniques using the Rehabilitation Adherence Index (RAI) questionnaire.
Adherence will be assessed using the Rehabilitation Adherence Index (RAI) questionnaire, with scores ranging from 1 to 7, where higher scores indicate better adherence.
Measured: six weeks
Usability of pulmonary rehabilitation techniques using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire
Usability will be measured using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire, with scores ranging from 1 to 7, where higher scores indicate better usability.
Measured: six weeks
Secondary outcomes (5)
To describe the change in perception of dyspnea at baseline and at the end of the PR using Modified Medical Research Council (mMRC) questionnaire.
The Modified Medical Research Council (mMRC) questionnaire assesses the perception of dyspnea with scores ranging from 0 to 4, with higher scores indicating greater severity.
Measured: six weeks
To describe the change in quality of life at baseline and at the end of the PR using EuroQol-5D (EQ-5D) questionnaire.
The EQ-5D questionnaire assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity: no problems, slight problems, moderate problems, severe problems, and unable to perform/extreme problems. Additionally, the EQ-5D includes a visual analogue scale (VAS) where respondents rate their overall health on a scale from 0 to 100, with 0 being the worst imaginable health and 100 being the best.
Measured: six weeks
To assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on AATD- related COPD patients using COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) is assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on a person's daily life. It ranges from 0 to 5, where higher scores indicate a greater impact of COPD on daily life
Measured: six weeks
To assess the impact of asthma on AATD patients with asthma using the Asthma Control Test (ACT)
The Asthma Control Test (ACT) is a questionnaire used to assess asthma control, with scores ranging from 5 to 25. Higher scores indicate better asthma control, meaning the asthma is well-managed and less likely to interfere with daily activities.
Measured: six weeks
To describe the change in functional respiratory parameters at baseline and at the end of the PR program using spirometry.
Spirometry will be performed according to ATS/ERS standards to obtain Forced Expiratory Volume in 1 second (FEV₁, % predicted), Forced Vital Capacity (FVC, % predicted), and FEV₁/FVC, %.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start15 Nov 2024
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Alpha-1 Antitrypsin Deficiency (AATD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242079
- Sponsor's protocol ID
- 31276
- Acronym
- RRALFA1
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be collected in a dedicated electronic Clinical Records Form (CRF). The database will be saved on a password- protected company personal computer which will be updated at each visit and used exclusively for scientific research purposes. At the time of enrolment, each patient will receive an alphanumeric code so that any information collected during the study, and in particular sensitive data, will be treated in an anonymous manner. Data reporting patients' identifications will only be used to file patients and collect informed consent.
Publications
Conrad A, Janciauskiene S, Kohnlein T, Fuge J, Ivanyi P, Tudorache I, Gottlieb J, Welte T, Fuehner T. Impact of alpha 1-antitrypsin deficiency and prior augmentation therapy on patients' survival after lung transplantation. Eur Respir J. 2017 Sep 10;50(3):1700962. doi: 10.1183/13993003.00962-2017. Print 2017 Sep. No abstract available.
PubMed 28890438Cerdan de Las Heras J, Tulppo M, Kiviniemi AM, Hilberg O, Lokke A, Ekholm S, Catalan-Matamoros D, Bendstrup E. Augmented reality glasses as a new tele-rehabilitation tool for home use: patients' perception and expectations. Disabil Rehabil Assist Technol. 2022 May;17(4):480-486. doi: 10.1080/17483107.2020.1800111. Epub 2020 Aug 4.
PubMed 32750254Patsaki I, Avgeri V, Rigoulia T, Zekis T, Koumantakis GA, Grammatopoulou E. Benefits from Incorporating Virtual Reality in Pulmonary Rehabilitation of COPD Patients: A Systematic Review and Meta-Analysis. Adv Respir Med. 2023 Aug 10;91(4):324-336. doi: 10.3390/arm91040026.
PubMed 37622840Hayton C, Clark A, Olive S, Browne P, Galey P, Knights E, Staunton L, Jones A, Coombes E, Wilson AM. Barriers to pulmonary rehabilitation: characteristics that predict patient attendance and adherence. Respir Med. 2013 Mar;107(3):401-7. doi: 10.1016/j.rmed.2012.11.016. Epub 2012 Dec 19.
PubMed 23261311Depew ZS, Novotny PJ, Benzo RP. How many steps are enough to avoid severe physical inactivity in patients with chronic obstructive pulmonary disease? Respirology. 2012 Aug;17(6):1026-7. doi: 10.1111/j.1440-1843.2012.02207.x.
PubMed 22672739Savci S, Ince DI, Arikan H. A comparison of autogenic drainage and the active cycle of breathing techniques in patients with chronic obstructive pulmonary diseases. J Cardiopulm Rehabil. 2000 Jan-Feb;20(1):37-43. doi: 10.1097/00008483-200001000-00006.
PubMed 10680096Zisi D, Chryssanthopoulos C, Nanas S, Philippou A. The effectiveness of the active cycle of breathing technique in patients with chronic respiratory diseases: A systematic review. Heart Lung. 2022 May-Jun;53:89-98. doi: 10.1016/j.hrtlng.2022.02.006. Epub 2022 Feb 27.
PubMed 35235877Barjaktarevic I, Campos M. Management of lung disease in alpha-1 antitrypsin deficiency: what we do and what we do not know. Ther Adv Chronic Dis. 2021 Jul 29;12_suppl:20406223211010172. doi: 10.1177/20406223211010172. eCollection 2021.
PubMed 34408831Alwadani FA, Wheeler K, Pittaway H, Turner AM. Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease Patients with Underlying Alpha-1 Antitrypsin Deficiency: A Systematic Review and Practical Recommendations. Chronic Obstr Pulm Dis. 2024 Jan 25;11(1):121-132. doi: 10.15326/jcopdf.2023.0434.
PubMed 37813825Nici L, Donner C, Wouters E, Zuwallack R, Ambrosino N, Bourbeau J, Carone M, Celli B, Engelen M, Fahy B, Garvey C, Goldstein R, Gosselink R, Lareau S, MacIntyre N, Maltais F, Morgan M, O'Donnell D, Prefault C, Reardon J, Rochester C, Schols A, Singh S, Troosters T; ATS/ERS Pulmonary Rehabilitation Writing Committee. American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1390-413. doi: 10.1164/rccm.200508-1211ST. No abstract available.
PubMed 16760357Crystal RG. Alpha 1-antitrypsin deficiency, emphysema, and liver disease. Genetic basis and strategies for therapy. J Clin Invest. 1990 May;85(5):1343-52. doi: 10.1172/JCI114578. No abstract available.
PubMed 2185272Nukiwa T, Brantly M, Ogushi F, Fells G, Satoh K, Stier L, Courtney M, Crystal RG. Characterization of the M1(Ala213) type of alpha 1-antitrypsin, a newly recognized, common "normal" alpha 1-antitrypsin haplotype. Biochemistry. 1987 Aug 25;26(17):5259-67. doi: 10.1021/bi00391a008.
PubMed 2890373Brantly M, Nukiwa T, Crystal RG. Molecular basis of alpha-1-antitrypsin deficiency. Am J Med. 1988 Jun 24;84(6A):13-31. doi: 10.1016/0002-9343(88)90154-4.
PubMed 3289385DeMeo DL, Silverman EK. Alpha1-antitrypsin deficiency. 2: genetic aspects of alpha(1)-antitrypsin deficiency: phenotypes and genetic modifiers of emphysema risk. Thorax. 2004 Mar;59(3):259-64. doi: 10.1136/thx.2003.006502.
PubMed 14985567Long GL, Chandra T, Woo SL, Davie EW, Kurachi K. Complete sequence of the cDNA for human alpha 1-antitrypsin and the gene for the S variant. Biochemistry. 1984 Oct 9;23(21):4828-37. doi: 10.1021/bi00316a003.
PubMed 6093867
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulmonary Rehabilitation and Physical Activity in Patients With Alpha-1 Antitrypsin Deficiency
- ClinicalTrials.gov ID
- NCT07242079
- Acronym / sponsor ID
- RRALFA1 / 31276
- Conditions
- Alpha-1 Antitrypsin Deficiency (AATD)
- Keywords
- Alpha-1 antitrypsin deficiency, Pulmonary rehabilitation, Active Cycle of Breathing Technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 21 Nov 2025 (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.
This single-center, longitudinal, observational, prospective study aims to assess the applicability, adherence, and clinical impact of the Active Cycle of Breathing Technique (ACBT) with augmented reality support in patients with alpha-1 antitrypsin deficiency (AATD).
A total of 50 adult AATD patients will be recruit from the Lung Function Unit of the University Hospital of Parma, meeting specific inclusion criteria. Participants will perform ACBT twice daily and walk at least 5000 steps per day. Clinical and functional outcomes including dyspnea perception, lung function, and quality of life, will be assessed before and after a six-week ACBT program.
The study explores whether augmented reality enhance adherence and efficacy compared to conventional pulmonary rehabilitation (PR) methods. The expected outcome is improved adherence to PR.
Detailed description
Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder caused by mutations in the SERPINA1 gene, located on chromosome 14. The condition is characterized by low circulating levels of alpha-1 antitrypsin (AAT), a glycoprotein primarily produced by hepatocytes, which plays a crucial role in inhibiting neutrophil elastase (NE). Without adequate AAT, unregulated NE activity damages the lung parenchyma, leading to progressive emphysema. AATD presents with variable phenotypic expression, ranging from asymptomatic individuals to those with severe pulmonary and hepatic complications.
Treatment includes intravenous AAT replacement therapy, vaccination and guideline-recommended pulmonary rehabilitation (PR) based on the patient's clinical condition.
PR consists of a structured program combining breathing exercises, physical training, education, and psychological support to optimize respiratory function and improve patients' quality of life. One of the most effective techniques within PR is the Active Cycle of Breathing Technique (ACBT), which enhances airway clearance and lung function. ACBT is a simple, standardized, and home-based technique that patients can perform with or without digital tools. ACBT has already been shown to improve forced vital capacity, peak expiratory flow, arterial oxygenation and exercise capacity.
A tendency towards poor adherence to PR has been reported in the literature. To facilitate the performance of PR procedures, technological evolution in recent decades has brought new complementary techniques such as active video games, virtual reality and augmented reality.
ThIs study aims to assess satisfaction, adherence, and usability of pulmonary rehabilitation techniques in AATD patients, both with and without technological support, through relevant questionnaires (VAS, RAI, USE, TAM). Additionally, it aims to describe changes in the perception of dyspnea (mMRC), quality of life (EuroQol 5), impact of the pathology on daily life, and some functional parameters (FEV1, FVC, R5-R20, LCI, metres walked assessed by the six-minute walking test) at baseline and at the end of the rehabilitation program.
Data will be collected in a dedicated electronic Clinical Records Form (CRF). The database will be saved on a password-protected company Personal Computer (PC) which will be updated at each visit and used exclusively for scientific research purposes. At the time of enrollment, each patient will receive an alphanumeric code so that any information collected during the study, and in particular sensitive data, is treated in an anonymous manner. Data reporting patients' identifications will only be used to file patients and collect informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with alpha-1 antitrypsin deficiency (AATD) | – | Other: Pulmonary RehabilitationAdults with a confirmed diagnosis of alpha-1 antitrypsin deficiency (AATD) with asthma and/or COPD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will consist of 50 adult patients, referred at outpatient clinic of the Respiratory Disease Unit of the University Hospital of Parma (Italy)
Key inclusion criteria (3 listed)
- Male or female adults aged ≥18 years;
- Signed informed consent;
- All AATD patients, regardless of nephelometric alpha-1 antitrypsin dose and clinical phenotype, who require PR according to guidelines
Key exclusion criteria (1 listed)
- Subjects unable to perform the lung function tests and rehabilitation program required by the protocol
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 |
|---|---|---|
| Pulmonary Rehabilitationthe Active Cycle of Breathing Technique (ACBT) is a simple, standardized, and home-based technique that patients can perform with or without digital tools. ACBT has already been shown to improve forced vital capacity, peak expiratory flow, arterial oxygenation and exercise capacity. | Other | Patients with alpha-1 antitrypsin deficiency (AATD) |
Primary outcome
Patient satisfaction with PR techniques using Technology Acceptance Model (TAM) questionnaire.
Time frame: six weeks
Satisfaction will be assessed using the Technology Acceptance Model (TAM) questionnaire, with scores ranging from 1 to 7, where lower scores indicate more satisfaction.
Patient adherence to the PR techniques using the Rehabilitation Adherence Index (RAI) questionnaire.
Time frame: six weeks
Adherence will be assessed using the Rehabilitation Adherence Index (RAI) questionnaire, with scores ranging from 1 to 7, where higher scores indicate better adherence.
Usability of pulmonary rehabilitation techniques using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire
Time frame: six weeks
Usability will be measured using the Usefulness, Satisfaction and Ease of Use (USE) questionnaire, with scores ranging from 1 to 7, where higher scores indicate better usability.
5 secondary outcomes
To describe the change in perception of dyspnea at baseline and at the end of the PR using Modified Medical Research Council (mMRC) questionnaire.
Time frame: six weeks
To describe the change in quality of life at baseline and at the end of the PR using EuroQol-5D (EQ-5D) questionnaire.
Time frame: six weeks
To assess the impact of Chronic Obstructive Pulmonary Disease (COPD) on AATD- related COPD patients using COPD Assessment Test (CAT)
Time frame: six weeks
To assess the impact of asthma on AATD patients with asthma using the Asthma Control Test (ACT)
Time frame: six weeks
To describe the change in functional respiratory parameters at baseline and at the end of the PR program using spirometry.
Time frame: six weeks
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 21 Nov 2025.
- Results publication: PubMed 28890438Conrad A, Janciauskiene S, Kohnlein T, Fuge J, Ivanyi P, Tudorache I, Gottlieb J, Welte T, Fuehner T. Impact of alpha 1-antitrypsin deficiency and prior augmentation therapy on patients' survival after lung transplantation. Eur Respir J. 2017 Sep 10;50(3):1700962. doi: 10.1183/13993003.00962-2017. Print 2017 Sep. No abstract available.
- Results publication: PubMed 32750254Cerdan de Las Heras J, Tulppo M, Kiviniemi AM, Hilberg O, Lokke A, Ekholm S, Catalan-Matamoros D, Bendstrup E. Augmented reality glasses as a new tele-rehabilitation tool for home use: patients' perception and expectations. Disabil Rehabil Assist Technol. 2022 May;17(4):480-486. doi: 10.1080/17483107.2020.1800111. Epub 2020 Aug 4.
- Results publication: PubMed 37622840Patsaki I, Avgeri V, Rigoulia T, Zekis T, Koumantakis GA, Grammatopoulou E. Benefits from Incorporating Virtual Reality in Pulmonary Rehabilitation of COPD Patients: A Systematic Review and Meta-Analysis. Adv Respir Med. 2023 Aug 10;91(4):324-336. doi: 10.3390/arm91040026.
- Results publication: PubMed 23261311Hayton C, Clark A, Olive S, Browne P, Galey P, Knights E, Staunton L, Jones A, Coombes E, Wilson AM. Barriers to pulmonary rehabilitation: characteristics that predict patient attendance and adherence. Respir Med. 2013 Mar;107(3):401-7. doi: 10.1016/j.rmed.2012.11.016. Epub 2012 Dec 19.
- Results publication: PubMed 22672739Depew ZS, Novotny PJ, Benzo RP. How many steps are enough to avoid severe physical inactivity in patients with chronic obstructive pulmonary disease? Respirology. 2012 Aug;17(6):1026-7. doi: 10.1111/j.1440-1843.2012.02207.x.
- Results publication: PubMed 10680096Savci S, Ince DI, Arikan H. A comparison of autogenic drainage and the active cycle of breathing techniques in patients with chronic obstructive pulmonary diseases. J Cardiopulm Rehabil. 2000 Jan-Feb;20(1):37-43. doi: 10.1097/00008483-200001000-00006.
- Results publication: PubMed 35235877Zisi D, Chryssanthopoulos C, Nanas S, Philippou A. The effectiveness of the active cycle of breathing technique in patients with chronic respiratory diseases: A systematic review. Heart Lung. 2022 May-Jun;53:89-98. doi: 10.1016/j.hrtlng.2022.02.006. Epub 2022 Feb 27.
- Results publication: PubMed 34408831Barjaktarevic I, Campos M. Management of lung disease in alpha-1 antitrypsin deficiency: what we do and what we do not know. Ther Adv Chronic Dis. 2021 Jul 29;12_suppl:20406223211010172. doi: 10.1177/20406223211010172. eCollection 2021.
- Results publication: PubMed 37813825Alwadani FA, Wheeler K, Pittaway H, Turner AM. Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease Patients with Underlying Alpha-1 Antitrypsin Deficiency: A Systematic Review and Practical Recommendations. Chronic Obstr Pulm Dis. 2024 Jan 25;11(1):121-132. doi: 10.15326/jcopdf.2023.0434.
- Results publication: PubMed 16760357Nici L, Donner C, Wouters E, Zuwallack R, Ambrosino N, Bourbeau J, Carone M, Celli B, Engelen M, Fahy B, Garvey C, Goldstein R, Gosselink R, Lareau S, MacIntyre N, Maltais F, Morgan M, O'Donnell D, Prefault C, Reardon J, Rochester C, Schols A, Singh S, Troosters T; ATS/ERS Pulmonary Rehabilitation Writing Committee. American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1390-413. doi: 10.1164/rccm.200508-1211ST. No abstract available.
- Results publication: PubMed 2185272Crystal RG. Alpha 1-antitrypsin deficiency, emphysema, and liver disease. Genetic basis and strategies for therapy. J Clin Invest. 1990 May;85(5):1343-52. doi: 10.1172/JCI114578. No abstract available.
- Results publication: PubMed 2890373Nukiwa T, Brantly M, Ogushi F, Fells G, Satoh K, Stier L, Courtney M, Crystal RG. Characterization of the M1(Ala213) type of alpha 1-antitrypsin, a newly recognized, common "normal" alpha 1-antitrypsin haplotype. Biochemistry. 1987 Aug 25;26(17):5259-67. doi: 10.1021/bi00391a008.
- Individual participant dataSharing planned: Yes. Data will be collected in a dedicated electronic Clinical Records Form (CRF). The database will be saved on a password- protected company personal computer which will be updated at each visit and used exclusively for scientific research purposes. At the time of enrolment, each patient will receive an alphanumeric code so that any information collected during the study, and in particular sensitive data, will be treated in an anonymous manner. Data reporting patients' identifications will only be used to file patients and collect informed consent.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alpha-1 Antitrypsin Deficiency (AATD), run by University of Parma at 1 site in Italy.
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 1 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Patient satisfaction with PR techniques using Technology Acceptance Model (TAM) questionnaire. (time frame: six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07242079, which also lists 17 linked publications.
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 21 Nov 2025.