COPDNCT07079527
Effects of Manual Positive End Expiratory Pressure and Non-invasive Continuous Positive Air Pressure in COPD Patients
A study testing Manual Positive End Expiratory Pressure (PEEP) Therapy and Non-Invasive CPAP Therapy in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
This randomized clinical trial aims to compare the effectiveness of Manual Positive End Expiratory Pressure (PEEP) and Non-Invasive Continuous Positive Airway Pressure (CPAP) in patients with Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- COPD
- What is being tested?
- Manual Positive End Expiratory Pressure (PEEP) Therapy and Non-Invasive CPAP Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jul 2025to 10 Dec 2025
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>40years old
- SevereCOPDpatients with Stage 3 \& 4 according to Gold Criteria
- Notcurrently experiencing an acute exacerbation.
- Baseline Forced Expiratory Volume in 1 second (FEV1) < 70% of predicted
- Ability to provide informed consent.
Who cannot join
- Othersignificant respiratory diseases (e.g., asthma, pulmonary fibrosis, cystic fibrosis)
- Invasive mechanical ventilation
- Pregnant or Breastfeeding women
- Cardiac arrhythmias or instability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Arjumand
Lahore, Punjab Province, 40100
Arjumand Bano, MS-CPPT, 03059551883, arjumand.bano@riphah.edu.pk
Naima Aqeel, MS-CPPT
About this study
Official title: Comparative Effects of Manual Positive End Expiratory Pressure and Non Invasive Continuous Air Pressure in COPD Patients
This randomized clinical trial aims to compare the effectiveness of Manual Positive End Expiratory Pressure (PEEP) and Non-Invasive Continuous Positive Airway Pressure (CPAP) in patients with Chronic Obstructive Pulmonary Disease (COPD). A total of 42 patients will be randomly assigned to two groups: one receiving manual PEEP therapy and the other receiving CPAP therapy, over a 4-week period. The primary goal is to assess and compare improvements in respiratory rate, oxygen saturation (SpO₂), and patient-reported breathlessness and comfort using standardized tools such as pulse oximetry, digital spirometry, the Borg dyspnea scale, and the COPD Assessment Test. The study is designed as a single-blind randomized trial and will be conducted at Imran Idrees and Allama Iqbal Memorial Hospitals in Sialkot. The outcomes are expected to guide better non-invasive management strategies for COPD patients to enhance clinical outcomes and quality of life.
Read the detailed description
This randomized clinical trial investigates the comparative effectiveness of Manual Positive End Expiratory Pressure (PEEP) and Non-Invasive Continuous Positive Airway Pressure (CPAP) in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a progressive respiratory condition characterized by airflow limitation, leading to breathlessness, decreased exercise tolerance, and frequent hospitalizations. Non-invasive ventilation techniques such as PEEP and CPAP are widely used to manage respiratory symptoms and improve lung function in these patients, but direct comparisons of their efficacy remain limited.
A total of 42 patients with Stage 3 or 4 COPD, aged over 40 years, will be enrolled and randomly assigned to two groups:
Group A will receive manual PEEP therapy
Group B will receive non-invasive CPAP therapy
The intervention will last four weeks, and all patients will receive baseline treatment in the form of Active Cycle of Breathing Techniques (ACBTs). The study will be conducted at Imran Idrees Teaching Hospital and Allama Iqbal Memorial Hospital, Sialkot.
Primary outcome measures include improvements in:
Oxygen saturation (SpO₂)
Respiratory rate
Patient-reported breathlessness (using the Borg scale)
Quality of life and symptom severity (using the COPD Assessment Test)
Data collection tools include pulse oximetry, digital spirometry (for FEV₁, FVC, PEF), and standardized questionnaires. The study uses a single-blind design, where the assessor is blinded to the group allocation.
The purpose is to determine which intervention-manual PEEP or CPAP-offers superior clinical outcomes, patient comfort, and symptom relief. Findings from this research aim to support evidence-based decision-making for non-invasive COPD management in clinical settings.
- Conditions
- COPD
- Being tested
- Manual Positive End Expiratory Pressure (PEEP) Therapy, Non-Invasive CPAP Therapy
- Keywords
- COPD, Posotive end expiratory pressure, CPAP
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Positive End Expiratory Pressure (PEEP) TherapyDevice
Participants in this group receive Manual Positive End Expiratory Pressure (PEEP) therapy. The intervention is delivered using a tight-fitting mask that applies positive pressure at the end of expiration, helping to keep the alveoli open, enhance oxygenation, and prevent airway collapse. The therapy is administered according to a structured protocol over a 4-week period, aiming to reduce breathlessness, improve lung function, and support ventilation. Along with PEEP, participants also receive baseline Active Cycle of Breathing Techniques (ACBTs) for airway clearance and breathing control.
Non-Invasive CPAP TherapyDevice
Participants in this group receive Non-Invasive Continuous Positive Airway Pressure (CPAP) therapy. CPAP provides a constant level of positive pressure throughout the entire breathing cycle using a non-invasive ventilator and a full-face or nasal mask. This therapy improves gas exchange, reduces the work of breathing, and eases symptoms such as dyspnea. Like Group A, CPAP therapy is delivered following a standardized protocol for 4 weeks, and participants also perform baseline ACBTs to support respiratory function.
| Study group | Role | What they receive |
|---|---|---|
| Manual PEEP Therapy | Experimental | Participants in this group receive Manual Positive End Expiratory Pressure (PEEP) therapy. The therapy is administered using a tight-fitting mask that applies positive pressure at the end of expiration to keep alveoli open, enhance oxygenation, reduce airway collapse, and improve breathing efficiency. Sessions follow a standardized protocol over a 4-week period. All participants also receive Active Cycle of Breathing Techniques (ACBTs) as baseline therapy. Receives: Device: Manual Positive End Expiratory Pressure (PEEP) Therapy |
| Non-Invasive CPAP Therapy | Experimental | Participants in this group receive Non-Invasive Continuous Positive Airway Pressure (CPAP) therapy. CPAP delivers a constant level of positive pressure throughout the respiratory cycle using a non-invasive ventilator. This helps reduce the work of breathing, improve gas exchange, and relieve symptoms of dyspnea. The intervention is delivered according to a standardized protocol for 4 weeks, along with baseline ACBTs. Receives: Device: Non-Invasive CPAP Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SpO₂ (Oxygen Saturation) from Baseline to Post-Intervention
Oxygen saturation (%) will be measured using a pulse oximeter before and after the 4-week intervention. The average change in SpO₂ will be compared within and between both groups.
Measured: 4 weeks
Change in Respiratory Rate (RR) from Baseline to Post-Intervention
Respiratory rate (breaths per minute) will be recorded at baseline and after 4 weeks. Lower respiratory rate post-intervention reflects clinical improvement.
Measured: 4 weeks
Borg Dyspnea Scale Score from Baseline to Post-Intervention at 4 weeks
The Borg Dyspnea Scale, a 0-10 point subjective scale, will be used to evaluate the severity of dyspnea in COPD patients. A score of 0 represents no breathlessness, and a score of 10 represents maximal breathlessness. Higher scores indicate worse outcomes (i.e., more severe dyspnea). Measurements will be taken at baseline and after the 8-week intervention. The primary analysis will focus on the change in median score from pre- to post-intervention within and between groups.
MaximumHigher scores indicate worse dyspnea (more severe breathlessness) score: 10
Measured: 4 weeks
Secondary outcomes (1)
Change in Distance Walked during 6-Minute Walk Test (6MWT)
Total distance walked (in meters) during the 6MWT will be recorded. Higher distance reflects improved functional capacity.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start28 Jul 2025 (estimated)
- Primary completion28 Nov 2025 (estimated)
- Study completion10 Dec 2025 (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 Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjumand Bano, Ms CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079527
- Sponsor's protocol ID
- REC/RCR&AHS/24/0357
- Status last verified
- Jul 2025
- First submitted
- 3 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Manual Positive End Expiratory Pressure and Non Invasive Continuous Air Pressure in COPD Patients
- ClinicalTrials.gov ID
- NCT07079527
- Acronym / sponsor ID
- REC/RCR&AHS/24/0357
- Conditions
- COPD
- Keywords
- COPD, Posotive end expiratory pressure, CPAP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Jul 2025 (estimated)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 23 Jul 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 randomized clinical trial aims to compare the effectiveness of Manual Positive End Expiratory Pressure (PEEP) and Non-Invasive Continuous Positive Airway Pressure (CPAP) in patients with Chronic Obstructive Pulmonary Disease (COPD). A total of 42 patients will be randomly assigned to two groups: one receiving manual PEEP therapy and the other receiving CPAP therapy, over a 4-week period. The primary goal is to assess and compare improvements in respiratory rate, oxygen saturation (SpO₂), and patient-reported breathlessness and comfort using standardized tools such as pulse oximetry, digital spirometry, the Borg dyspnea scale, and the COPD Assessment Test. The study is designed as a single-blind randomized trial and will be conducted at Imran Idrees and Allama Iqbal Memorial Hospitals in Sialkot. The outcomes are expected to guide better non-invasive management strategies for COPD patients to enhance clinical outcomes and quality of life.
Detailed description
This randomized clinical trial investigates the comparative effectiveness of Manual Positive End Expiratory Pressure (PEEP) and Non-Invasive Continuous Positive Airway Pressure (CPAP) in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a progressive respiratory condition characterized by airflow limitation, leading to breathlessness, decreased exercise tolerance, and frequent hospitalizations. Non-invasive ventilation techniques such as PEEP and CPAP are widely used to manage respiratory symptoms and improve lung function in these patients, but direct comparisons of their efficacy remain limited.
A total of 42 patients with Stage 3 or 4 COPD, aged over 40 years, will be enrolled and randomly assigned to two groups:
Group A will receive manual PEEP therapy
Group B will receive non-invasive CPAP therapy
The intervention will last four weeks, and all patients will receive baseline treatment in the form of Active Cycle of Breathing Techniques (ACBTs). The study will be conducted at Imran Idrees Teaching Hospital and Allama Iqbal Memorial Hospital, Sialkot.
Primary outcome measures include improvements in:
Oxygen saturation (SpO₂)
Respiratory rate
Patient-reported breathlessness (using the Borg scale)
Quality of life and symptom severity (using the COPD Assessment Test)
Data collection tools include pulse oximetry, digital spirometry (for FEV₁, FVC, PEF), and standardized questionnaires. The study uses a single-blind design, where the assessor is blinded to the group allocation.
The purpose is to determine which intervention-manual PEEP or CPAP-offers superior clinical outcomes, patient comfort, and symptom relief. Findings from this research aim to support evidence-based decision-making for non-invasive COPD management in clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual PEEP Therapy | Experimental | Device: Manual Positive End Expiratory Pressure (PEEP) TherapyParticipants in this group receive Manual Positive End Expiratory Pressure (PEEP) therapy. The therapy is administered using a tight-fitting mask that applies positive pressure at the end of expiration to keep alveoli open, enhance oxygenation, reduce airway collapse, and improve breathing efficiency. Sessions follow a standardized protocol over a 4-week period. All participants also receive Active Cycle of Breathing Techniques (ACBTs) as baseline therapy. |
| Non-Invasive CPAP Therapy | Experimental | Device: Non-Invasive CPAP TherapyParticipants in this group receive Non-Invasive Continuous Positive Airway Pressure (CPAP) therapy. CPAP delivers a constant level of positive pressure throughout the respiratory cycle using a non-invasive ventilator. This helps reduce the work of breathing, improve gas exchange, and relieve symptoms of dyspnea. The intervention is delivered according to a standardized protocol for 4 weeks, along with baseline ACBTs. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>40years old
- SevereCOPDpatients with Stage 3 \& 4 according to Gold Criteria
- Notcurrently experiencing an acute exacerbation.
- Baseline Forced Expiratory Volume in 1 second (FEV1) < 70% of predicted
- Ability to provide informed consent.
Key exclusion criteria (4 listed)
- Othersignificant respiratory diseases (e.g., asthma, pulmonary fibrosis, cystic fibrosis)
- Invasive mechanical ventilation
- Pregnant or Breastfeeding women
- Cardiac arrhythmias or instability
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 |
|---|---|---|
| Manual Positive End Expiratory Pressure (PEEP) TherapyParticipants in this group receive Manual Positive End Expiratory Pressure (PEEP) therapy. The intervention is delivered using a tight-fitting mask that applies positive pressure at the end of expiration, helping to keep the alveoli open, enhance oxygenation, and prevent airway collapse. The therapy is administered according to a structured protocol over a 4-week period, aiming to reduce breathlessness, improve lung function, and support ventilation. Along with PEEP, participants also receive baseline Active Cycle of Breathing Techniques (ACBTs) for airway clearance and breathing control. | Device | Manual PEEP Therapy |
| Non-Invasive CPAP TherapyParticipants in this group receive Non-Invasive Continuous Positive Airway Pressure (CPAP) therapy. CPAP provides a constant level of positive pressure throughout the entire breathing cycle using a non-invasive ventilator and a full-face or nasal mask. This therapy improves gas exchange, reduces the work of breathing, and eases symptoms such as dyspnea. Like Group A, CPAP therapy is delivered following a standardized protocol for 4 weeks, and participants also perform baseline ACBTs to support respiratory function. | Device | Non-Invasive CPAP Therapy |
Primary outcome
Change in SpO₂ (Oxygen Saturation) from Baseline to Post-Intervention
Time frame: 4 weeks
Oxygen saturation (%) will be measured using a pulse oximeter before and after the 4-week intervention. The average change in SpO₂ will be compared within and between both groups.
Change in Respiratory Rate (RR) from Baseline to Post-Intervention
Time frame: 4 weeks
Respiratory rate (breaths per minute) will be recorded at baseline and after 4 weeks. Lower respiratory rate post-intervention reflects clinical improvement.
Borg Dyspnea Scale Score from Baseline to Post-Intervention at 4 weeks
Time frame: 4 weeks
The Borg Dyspnea Scale, a 0-10 point subjective scale, will be used to evaluate the severity of dyspnea in COPD patients. A score of 0 represents no breathlessness, and a score of 10 represents maximal breathlessness. Higher scores indicate worse outcomes (i.e., more severe dyspnea). Measurements will be taken at baseline and after the 8-week intervention. The primary analysis will focus on the change in median score from pre- to post-intervention within and between groups. MaximumHigher scores indicate worse dyspnea (more severe breathlessness) score: 10
1 secondary outcome
Change in Distance Walked during 6-Minute Walk Test (6MWT)
Time frame: 4 weeks
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 23 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Arjumand Bano, Ms CPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Positive End Expiratory Pressure (PEEP) Therapy and Non-Invasive CPAP Therapy in people with COPD, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 4 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 imran amjad, phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SpO₂ (Oxygen Saturation) from Baseline to Post-Intervention (time frame: 4 weeks). The study lists 3 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 23 Jul 2025.