COPDNCT07198880
Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital
A study testing BiPAP device (non invasive ventilation) and Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids) in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by Assiut University.
Trial summary
This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Ventilation Therapy
- What is being tested?
- BiPAP device (non invasive ventilation) and Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients more than 18 year old.
- Severe COPD (classified as GOLD stage Ⅲ and IV), confirmed by FEV₁/FVC < 70% and FEV₁ < 50% of the predicted value. (9)
- Persistent hypercapnia (PaCO₂ ≥ 60 mmHg ≥2 weeks after resolution of acute exacerbation and compliant on optimal medical therapy with or without long term oxygen therapy
Who cannot join
- Other significant respiratory disorders (e.g,history suggestive OSA, Body Mass Index more than 30, pneumothorax, bullous lung disease, advanced interstitial lung diseases , restrictive thoracic wall diseases , neuromuscular disease).
- Undergone intubation or tracheostomy prior to NIV initiation during the last 2 months.
- Those using addictive narcotic medications.
- Comorbidities and diseases that might confound survival outcomes (e.g., malignancy, advanced hepatic or renal diseases).
- Pregnancy
- Refusal or Inability to tolerate NIV during initiation and adaptation phase.
- Expected Poor compliance (patients deemed unlikely to adhere to nightly NIV use such as no family support, severe frailty).
- Withdrawal criteria: stopping bipap or medical treatment, voluntary withdrawal by the participant, failure to attend scheduled visits, and significant clinical deterioration requiring alternative management during the study period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide . A subset of patients develops chronic hypercapnia, which is linked to frequent hospitalizations, reduced quality of life, and poor survival. Despite optimized pharmacological therapy, pulmonary rehabilitation, and long-term oxygen therapy (LTOT), outcomes in these patients remain unsatisfactory.
Early randomized trials failed to show survival benefit from home Non Invasive Ventilation , largely due to low ventilatory pressures, poor adherence, and heterogeneous patient selection . More recent studies suggest a positive impact and demonstrated improved long-term survival, some studies reported reduced mortality with high-intensity NIV targeting PaCO₂ reduction .
Meta-analyses indicate that patients with persistent hypercapnia after an acute exacerbation are most likely to benefit , though uncertainties remain regarding patient selection and long-term real-world outcomes.
Management of chronic hypercapnic COPD currently includes pharmacological treatment, LTOT, and rehabilitation.
NIV is a cornerstone in acute exacerbations, but its role in the chronic setting is not universally established, and routine use in home care is limited.
- Conditions
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Ventilation Therapy, Non Invasive Ventilation (NIV), BiPAP, Hypercapnia
- Being tested
- BiPAP device (non invasive ventilation), Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiPAP device (non invasive ventilation)Device
BiPAP initiated 2-4 weeks post-discharge; IPAP 16 cmH₂O (titrate), EPAP 4 cmH₂O; supplemental O₂ as needed monitor SpO₂, ABG, vitals; target ≥20% PaCO₂ reduction, improved pH, reduced work of breathing; adherence ≥4 hrs/nigh
Scheduled monitoring of SpO₂, symptoms, and adherence; outpatient follow-up at 2-4 weeks and after 1, 3, 6 ,12 month intervals
Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)Drug
Patients will continue on standard COPD management: inhaled bronchodilators, inhaled corticosteroids, LTOT when required, but without NIV
| Study group | Role | What they receive |
|---|---|---|
| NIV Group | Experimental | Patients who can afford to buy or attain a Bi-PAP device will be enrolled in this interventional group long-term NIV (Bi-PAP), They will also keep taking their optimal medical therapy, with or without LTOT according to oxygen status. Receives: Device: BiPAP device (non invasive ventilation); Drug: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids) |
| Control Group | Active comparator | Patients who cannot attain a BiPAP device are managed with their optimal medical therapy, with or without LTOT according to oxygen status Receives: Drug: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in arterial blood gas parameter "PaCO₂"
follow up PaCo2 level measured by mmhg
Measured: 1 year
Assessment of Adherence to BiPAP therapy
measured as the average hours of nightly use
Measured: 1 year
Secondary outcomes (6)
Improvements in quality of life
Measured using the validated St. George's Respiratory Questionnaire - COPD. Scale range: 0-100 (0 = no impairment, 100 = maximum impairment). Direction: Higher scores indicate worse quality of life.
Measured: 1 year
Improvement in Dyspnea
Measured using the Modified Medical Research Council (mMRC) Dyspnea Scale. Scale range: 0-4 (0 = no breathlessness, 4 = severe breathlessness). Direction: Higher scores indicate worse dyspnea.
Measured: 1 year
Improvement in COPD-Related Symptoms
Measured using the COPD Assessment Test (CAT). Scale range: 0-40 (0 = no symptoms, 40 = very severe symptoms). Direction: Higher scores indicate more severe symptoms and worse impact on daily life.
Measured: 1 year
Total Duration of COPD-Related Hospitalization per Year
Documented as the cumulative number of days spent in hospital for COPD exacerbations during the study period.
Unit of Measure: Days hospitalized per participant per year
Measured: 1 year
Number of COPD-Related Hospitalizations per Year
Documented as the total number of hospital admissions for COPD exacerbations during the study period.
Unit of Measure: Number of hospitalizations per participant per year
Measured: 1 year
Assessment of Overall survival
Assessment of Overall survival between 2 cohorts (one year mortality)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud Ahmed AbdAllah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198880
- Sponsor's protocol ID
- NIV in COPD Patients
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Home Non Invasive Ventilation in Patients With Chronic Obstructive Pulmonary Disease Discharged From Assiut University Hospital
- ClinicalTrials.gov ID
- NCT07198880
- Acronym / sponsor ID
- NIV in COPD Patients
- Conditions
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Ventilation Therapy, Non Invasive Ventilation (NIV), BiPAP, Hypercapnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 30 Sep 2025 (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.
This study aims to evaluate the impact of long-term home non-invasive ventilation (NIV) on patients with COPD
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide . A subset of patients develops chronic hypercapnia, which is linked to frequent hospitalizations, reduced quality of life, and poor survival. Despite optimized pharmacological therapy, pulmonary rehabilitation, and long-term oxygen therapy (LTOT), outcomes in these patients remain unsatisfactory.
Early randomized trials failed to show survival benefit from home Non Invasive Ventilation , largely due to low ventilatory pressures, poor adherence, and heterogeneous patient selection . More recent studies suggest a positive impact and demonstrated improved long-term survival, some studies reported reduced mortality with high-intensity NIV targeting PaCO₂ reduction .
Meta-analyses indicate that patients with persistent hypercapnia after an acute exacerbation are most likely to benefit , though uncertainties remain regarding patient selection and long-term real-world outcomes.
Management of chronic hypercapnic COPD currently includes pharmacological treatment, LTOT, and rehabilitation.
NIV is a cornerstone in acute exacerbations, but its role in the chronic setting is not universally established, and routine use in home care is limited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV Group | Experimental | Device: BiPAP device (non invasive ventilation), Drug: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)Patients who can afford to buy or attain a Bi-PAP device will be enrolled in this interventional group long-term NIV (Bi-PAP), They will also keep taking their optimal medical therapy, with or without LTOT according to oxygen status. |
| Control Group | Active comparator | Drug: Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)Patients who cannot attain a BiPAP device are managed with their optimal medical therapy, with or without LTOT according to oxygen status |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients more than 18 year old.
- Severe COPD (classified as GOLD stage Ⅲ and IV), confirmed by FEV₁/FVC < 70% and FEV₁ < 50% of the predicted value. (9)
- Persistent hypercapnia (PaCO₂ ≥ 60 mmHg ≥2 weeks after resolution of acute exacerbation and compliant on optimal medical therapy with or without long term oxygen therapy
Key exclusion criteria (8 listed)
- Other significant respiratory disorders (e.g,history suggestive OSA, Body Mass Index more than 30, pneumothorax, bullous lung disease, advanced interstitial lung diseases , restrictive thoracic wall diseases , neuromuscular disease).
- Undergone intubation or tracheostomy prior to NIV initiation during the last 2 months.
- Those using addictive narcotic medications.
- Comorbidities and diseases that might confound survival outcomes (e.g., malignancy, advanced hepatic or renal diseases).
- Pregnancy
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 |
|---|---|---|
| BiPAP device (non invasive ventilation)BiPAP initiated 2-4 weeks post-discharge; IPAP 16 cmH₂O (titrate), EPAP 4 cmH₂O; supplemental O₂ as needed monitor SpO₂, ABG, vitals; target ≥20% PaCO₂ reduction, improved pH, reduced work of breathing; adherence ≥4 hrs/nigh Scheduled monitoring of SpO₂, symptoms, and adherence; outpatient follow-up at 2-4 weeks and after 1, 3, 6 ,12 month intervals | Device | NIV Group |
| Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids)Patients will continue on standard COPD management: inhaled bronchodilators, inhaled corticosteroids, LTOT when required, but without NIV | Drug | Control Group, NIV Group |
Primary outcome
Changes in arterial blood gas parameter "PaCO₂"
Time frame: 1 year
follow up PaCo2 level measured by mmhg
Assessment of Adherence to BiPAP therapy
Time frame: 1 year
measured as the average hours of nightly use
6 secondary outcomes
Improvements in quality of life
Time frame: 1 year
Improvement in Dyspnea
Time frame: 1 year
Improvement in COPD-Related Symptoms
Time frame: 1 year
Total Duration of COPD-Related Hospitalization per Year
Time frame: 1 year
Number of COPD-Related Hospitalizations per Year
Time frame: 1 year
Assessment of Overall survival
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP device (non invasive ventilation) and Optimal Medical Management ( long acting beta agonist , long acting muscarinic antagonist and inhaled corticosteroids) in people with COPD and COPD (Chronic Obstructive Pulmonary 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Mahmoud Ahmed (0201001554241, doc.mostafa5454@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in arterial blood gas parameter "PaCO₂" (time frame: 1 year). 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?
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 30 Sep 2025.