NCT04089826

Brief Summary

Study the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Status
unknown

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

September 1, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 16, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

September 10, 2019

Last Update Submit

September 12, 2019

Conditions

Long Term Oxygen TherapyInterstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

  • Dyspnea score improvement

    dyspnea by Modified Medical Research Counsel

    Baseline

  • Quality of life improvement

    Quality of life by st.George questionnaire

    Baseline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with ILDs who are prescribed for LTOT between eighteen and seventy years old

You may qualify if:

  • patients with ILD and hypoxia with SO2\<88 at room air and PO2 \< or equal 7.3k.pa or \< or equal 8 k.pa in presence of lower limb edema , pulmonary hypertension or polycythemia
  • age group 18 : 70

You may not qualify if:

  • Causes of chronic respiratory failure other than ILD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cobo-Ibanez T, Lopez-Longo FJ, Joven B, Carreira PE, Munoz-Fernandez S, Maldonado-Romero V, Larena-Grijalba C, Cubas IL, Muriel ET, Mateos CB, de la Pena Lefebvre PG, Gomez-Gomez A, Nogal LB, Perez A, Almodovar R, Lojo L, Ruiz-Gutierrez L, Lopez-Robledillo JC, Garcia de Yebenes MJ, Nuno-Nuno L. Long-term pulmonary outcomes and mortality in idiopathic inflammatory myopathies associated with interstitial lung disease. Clin Rheumatol. 2019 Mar;38(3):803-815. doi: 10.1007/s10067-018-4353-2. Epub 2018 Nov 3.

    PMID: 30392161BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Central Study Contacts

Asmaa Mahmoud Mohamed Eltayeb

CONTACT

01114203879asmaaeltayeb34@gmail.com

Atef Farouk Elqarn

CONTACT

01006474200

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at chest department Assiut university

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 13, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

September 16, 2019

Record last verified: 2019-08