Long Term Oxygen TherapyNCT04089826
Long Term Oxygen Therapy in Patients With Interstitial Lung Disease
An observational study of Long Term Oxygen Therapy and Interstitial Lung Disease, run by Assiut University.
Trial summary
Study the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Long Term Oxygen Therapy, Interstitial Lung Disease
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Oct 2020
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: patients with ILDs who are prescribed for LTOT between eighteen and seventy years old
Who may be able to join
- 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
Who cannot join
- Causes of chronic respiratory failure other than ILD.
Trial locations and contacts
No sites are listed yet.
Atef Farouk Elqarn contact
About this study
Official title: Role of LTOT in Pateints With ILD
Study the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia
Read the detailed description
long term oxygen can be used in patients with interstitial lung disease with hypoxia and the aim of this study is to k ow whether this will improve life style , exercise tolerance in those patients
- Medical subject headings
- Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea score improvement
dyspnea by Modified Medical Research Counsel
Measured: Baseline
Quality of life improvement
Quality of life by st.George questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long Term Oxygen TherapyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mahmoud Mohammed Eltayeb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089826
- Sponsor's protocol ID
- Role of LTOT in Pateints e ILD
- Status last verified
- Aug 2019
- First submitted
- 10 Sep 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30392161
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of LTOT in Pateints With ILD
- ClinicalTrials.gov ID
- NCT04089826
- Acronym / sponsor ID
- Role of LTOT in Pateints e ILD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 13 Sep 2019 (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 the effect of using long term oxygen therapy in patients with interstitial lung disease and chronic hypoxia
Detailed description
long term oxygen can be used in patients with interstitial lung disease with hypoxia and the aim of this study is to k ow whether this will improve life style , exercise tolerance in those patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with ILDs who are prescribed for LTOT between eighteen and seventy years old
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Causes of chronic respiratory failure other than ILD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dyspnea score improvement
Time frame: Baseline
dyspnea by Modified Medical Research Counsel
Quality of life improvement
Time frame: Baseline
Quality of life by st.George questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Background: PubMed 30392161Cobo-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.
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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.
Atef Farouk Elqarn contact
Questions about this trial
What is this clinical trial studying?
An observational study of Long Term Oxygen Therapy and Interstitial Lung Disease, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Mahmoud Mohamed Eltayeb (01114203879, asmaaeltayeb34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea score improvement (time frame: Baseline). The study lists 2 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 NCT04089826, which also lists 1 linked publication.
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 16 Sep 2019.