NCT04748900

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

February 5, 2021

Last Update Submit

February 9, 2021

Conditions

Keywords

Obstructive Pulmonary DiseasePhysiotherapy

Outcome Measures

Primary Outcomes (7)

  • Total volume

    ml

    3 months

  • Vital capacity

    ml

    3 months

  • Expiratory reserve volume

    ml

    3 months

  • Inspiratory reserve volume

    ml

    3 months

  • Inspiratory capacity

    ml

    3 months

  • Inspiration time

    seconds

    3 months

  • Expiratory time

    seconds

    3 months

Secondary Outcomes (2)

  • Total time

    3 months

  • Percentage inspiratory time

    3 months

Interventions

spirometerDIAGNOSTIC_TEST

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

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with respiratory insufficiency due to allergic bronchopulmonary aspergillosis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related 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. No abstract available.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Jorge V Saornil, PhD

    Universidad Católica de Ávila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 10, 2021

Study Start

October 1, 2020

Primary Completion

February 3, 2021

Study Completion

February 5, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations