Obstructive Pulmonary DiseaseNCT04748900

Physiotherapy Treatment Plan in Allergic Bronchopulmonary Aspergillosis: Case Report

An observational study of Obstructive Pulmonary Disease, run by Universidad Católica de Ávila at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 to 85 years, women only
Conditions the study is for: Obstructive Pulmonary Disease
What is being tested?: spirometer
How many people: 1 participants
Where: 1 siteSpain
Study dates: 1 Oct 2020to 5 Feb 2021
How long will I take part?: 3 Months
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 50 to 85 years
Women only
No healthy volunteers
Adult, Older adult

Study population: Patient with respiratory insufficiency due to allergic bronchopulmonary aspergillosis

Who may be able to join

woman
diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis
over 50 years of age
under 80 years of age

Who cannot join

male
not have a diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis
under 50 years of age
over 80 years of age

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad Católica de Ávila
Ávila, 05005

Other trials in Spain

About this study

Official title: Effects of a Respiratory Physiotherapy Treatment Plan in Allergic Bronchopulmonary Aspergillosis: Case Report

A spirometry study is performed in a patient diagnosed with allergic bronchopulmonary aspergillosis. An initial measurement is carried out and the patient is then put on a four-week physiotherapy treatment plan. Four spirometry measurements were taken to assess different variables and an improvement in all the spirometry values was established.

Conditions: Obstructive Pulmonary Disease
Being tested: spirometer
Keywords: Obstructive Pulmonary Disease, Physiotherapy
Medical subject headings: Lung Diseases, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

spirometerDiagnostic test
different values are measured on the spirometer after training in respiratory physiotherapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

Total volume
ml
Measured: 3 months
Vital capacity
ml
Measured: 3 months
Expiratory reserve volume
ml
Measured: 3 months
Inspiratory reserve volume
ml
Measured: 3 months
Inspiratory capacity
ml
Measured: 3 months
Inspiration time
seconds
Measured: 3 months
Expiratory time
seconds
Measured: 3 months

Secondary outcomes (2)

Total time
seconds
Measured: 3 months
Percentage inspiratory time
seconds
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20205 Feb 2021

First posted10 Feb 2021
Study start1 Oct 2020
Primary completion3 Feb 2021
Study completion5 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Obstructive Pulmonary DiseaseStudies 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: Case only
Time perspective: Cross-sectional
Enrolment: 1 participants (actual)
Target duration: 3 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04748900
Sponsor's protocol ID: 04/02/2021
Status last verified: Feb 2021
First submitted: 5 Feb 2021
Last updated: 10 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bonaiti G, Merati V, Pesci A, Faverio P. Allergic bronchopulmonary aspergillosis screening in bronchiectasis: is there always a precise answer to a clear question? Eur Ann Allergy Clin Immunol. 2019 Jan;51(1):41-43. doi: 10.23822/EurAnnACI.1764-1489.62. No abstract available.
PubMed 30638358
Cui L, Liu H, Sun L. Multidisciplinary respiratory rehabilitation in combination with non-invasive positive pressure ventilation in the treatment of elderly patients with severe chronic obstructive pulmonary disease. Pak J Med Sci. 2019 Mar-Apr;35(2):500-505. doi: 10.12669/pjms.35.2.459.
PubMed 31086540
Lareau SC, Fahy B. Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2018 Nov 15;198(10):P19-P20. doi: 10.1164/rccm.19810P19. No abstract available.
PubMed 30431331
Patel G, Greenberger PA. Allergic bronchopulmonary aspergillosis. Allergy Asthma Proc. 2019 Nov 1;40(6):421-424. doi: 10.2500/aap.2019.40.4262.
PubMed 31690385
Oguma T, Taniguchi M, Shimoda T, Kamei K, Matsuse H, Hebisawa A, Takayanagi N, Konno S, Fukunaga K, Harada K, Tanaka J, Tomomatsu K, Asano K. Allergic bronchopulmonary aspergillosis in Japan: A nationwide survey. Allergol Int. 2018 Jan;67(1):79-84. doi: 10.1016/j.alit.2017.04.011. Epub 2017 May 23.
PubMed 28546015
HINSON KF, MOON AJ, PLUMMER NS. Broncho-pulmonary aspergillosis; a review and a report of eight new cases. Thorax. 1952 Dec;7(4):317-33. doi: 10.1136/thx.7.4.317. No abstract available.
PubMed 13015523
Denning DW, Pleuvry A, Cole DC. Global burden of allergic bronchopulmonary aspergillosis with asthma and its complication chronic pulmonary aspergillosis in adults. Med Mycol. 2013 May;51(4):361-70. doi: 10.3109/13693786.2012.738312. Epub 2012 Dec 4.
PubMed 23210682
Kalaiyarasan, Jain AK, Puri M, Tayal D, Singhal R, Sarin R. Prevalence of allergic bronchopulmonary aspergillosis in asthmatic patients: A prospective institutional study. Indian J Tuberc. 2018 Oct;65(4):285-289. doi: 10.1016/j.ijtb.2018.04.007. Epub 2018 Apr 13.
PubMed 30522614
Sehgal IS, Choudhary H, Dhooria S, Aggarwal AN, Bansal S, Garg M, Behera D, Chakrabarti A, Agarwal R. Prevalence of sensitization to Aspergillus flavus in patients with allergic bronchopulmonary aspergillosis. Med Mycol. 2019 Apr 1;57(3):270-276. doi: 10.1093/mmy/myy012.
PubMed 29566248

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Respiratory Physiotherapy Treatment Plan in Allergic Bronchopulmonary Aspergillosis: Case Report
ClinicalTrials.gov ID: NCT04748900
Acronym / sponsor ID: 04/02/2021
Conditions: Obstructive Pulmonary Disease
Keywords: Obstructive Pulmonary Disease, Physiotherapy
Study type: Observational
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: Universidad Católica de ÁvilaUniversity, hospital or other
Study start: 1 Oct 2020 (actual)
Primary completion: 3 Feb 2021 (actual)
Study completion: 5 Feb 2021 (actual)
First posted: 10 Feb 2021 (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.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Target follow-up: 3 Months

Who may qualify

Ages: 50 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patient with respiratory insufficiency due to allergic bronchopulmonary aspergillosis

Key inclusion criteria (4 listed)

woman
diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis
over 50 years of age
under 80 years of age

Key exclusion criteria (4 listed)

male
not have a diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis
under 50 years of age
over 80 years of age

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
spirometerdifferent values are measured on the spirometer after training in respiratory physiotherapy.	Diagnostic test	–

Primary outcome

Total volume
Time frame: 3 months
ml
Vital capacity
Time frame: 3 months
ml
Expiratory reserve volume
Time frame: 3 months
ml
Inspiratory reserve volume
Time frame: 3 months
ml
Inspiratory capacity
Time frame: 3 months
ml
Inspiration time
Time frame: 3 months
seconds
Expiratory time
Time frame: 3 months
seconds

2 secondary outcomes

Total time
Time frame: 3 months
Percentage inspiratory time
Time frame: 3 months

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 10 Feb 2021.
Results publication: PubMed 30638358Bonaiti G, Merati V, Pesci A, Faverio P. Allergic bronchopulmonary aspergillosis screening in bronchiectasis: is there always a precise answer to a clear question? Eur Ann Allergy Clin Immunol. 2019 Jan;51(1):41-43. doi: 10.23822/EurAnnACI.1764-1489.62. No abstract available.
Results publication: PubMed 31086540Cui L, Liu H, Sun L. Multidisciplinary respiratory rehabilitation in combination with non-invasive positive pressure ventilation in the treatment of elderly patients with severe chronic obstructive pulmonary disease. Pak J Med Sci. 2019 Mar-Apr;35(2):500-505. doi: 10.12669/pjms.35.2.459.
Results publication: PubMed 30431331Lareau SC, Fahy B. Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2018 Nov 15;198(10):P19-P20. doi: 10.1164/rccm.19810P19. No abstract available.
Results publication: PubMed 31690385Patel G, Greenberger PA. Allergic bronchopulmonary aspergillosis. Allergy Asthma Proc. 2019 Nov 1;40(6):421-424. doi: 10.2500/aap.2019.40.4262.
Results publication: PubMed 28546015Oguma T, Taniguchi M, Shimoda T, Kamei K, Matsuse H, Hebisawa A, Takayanagi N, Konno S, Fukunaga K, Harada K, Tanaka J, Tomomatsu K, Asano K. Allergic bronchopulmonary aspergillosis in Japan: A nationwide survey. Allergol Int. 2018 Jan;67(1):79-84. doi: 10.1016/j.alit.2017.04.011. Epub 2017 May 23.
Results publication: PubMed 13015523HINSON KF, MOON AJ, PLUMMER NS. Broncho-pulmonary aspergillosis; a review and a report of eight new cases. Thorax. 1952 Dec;7(4):317-33. doi: 10.1136/thx.7.4.317. No abstract available.
Results publication: PubMed 23210682Denning DW, Pleuvry A, Cole DC. Global burden of allergic bronchopulmonary aspergillosis with asthma and its complication chronic pulmonary aspergillosis in adults. Med Mycol. 2013 May;51(4):361-70. doi: 10.3109/13693786.2012.738312. Epub 2012 Dec 4.
Results publication: PubMed 30522614Kalaiyarasan, Jain AK, Puri M, Tayal D, Singhal R, Sarin R. Prevalence of allergic bronchopulmonary aspergillosis in asthmatic patients: A prospective institutional study. Indian J Tuberc. 2018 Oct;65(4):285-289. doi: 10.1016/j.ijtb.2018.04.007. Epub 2018 Apr 13.
Results publication: PubMed 29566248Sehgal IS, Choudhary H, Dhooria S, Aggarwal AN, Bansal S, Garg M, Behera D, Chakrabarti A, Agarwal R. Prevalence of sensitization to Aspergillus flavus in patients with allergic bronchopulmonary aspergillosis. Med Mycol. 2019 Apr 1;57(3):270-276. doi: 10.1093/mmy/myy012.
Individual participant dataSharing planned: No

Related trials for Obstructive Pulmonary Disease

RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly

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.

Jorge V Saornil, PhD principal investigator

Universidad Católica de Ávila

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 Obstructive Pulmonary Disease, run by Universidad Católica de Ávila at 1 site in Spain.

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 4 inclusion and 4 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 10 Feb 2021. 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 Spain. 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?

Total volume (time frame: 3 months). The study lists 7 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 NCT04748900, which also lists 9 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 10 Feb 2021.