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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04748900
Other study ID # 04/02/2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date February 5, 2021

Study information

Verified date February 2021
Source Universidad Católica de Ávila
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date February 5, 2021
Est. primary completion date February 3, 2021
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - woman - diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis - over 50 years of age - under 80 years of age Exclusion Criteria: - male - not have a diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis - under 50 years of age - over 80 years of age

Study Design


Intervention

Diagnostic Test:
spirometer
different values are measured on the spirometer after training in respiratory physiotherapy.

Locations

Country Name City State
Spain Universidad Católica de Ávila Ávila

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica de Ávila

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

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- — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Lareau SC, Fahy B. Pulmonary Rehabilitation. Am J Respir Crit Care Med. 2018 Nov 15;198(10):P19-P20. doi: 10.1164/rccm.19810P19. — View Citation

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: 1 — View Citation

Patel G, Greenberger PA. Allergic bronchopulmonary aspergillosis. Allergy Asthma Proc. 2019 Nov 1;40(6):421-424. doi: 10.2500/aap.2019.40.4262. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total volume ml 3 months
Primary Vital capacity ml 3 months
Primary Expiratory reserve volume ml 3 months
Primary Inspiratory reserve volume ml 3 months
Primary Inspiratory capacity ml 3 months
Primary Inspiration time seconds 3 months
Primary Expiratory time seconds 3 months
Secondary Total time seconds 3 months
Secondary Percentage inspiratory time seconds 3 months
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