Acute Exacerbation CopdNCT07484178
Effectiveness of Nurse-Led Interventions on Respiratory Outcomes in Hospitalized Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study of Acute Exacerbation Copd, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to evaluate whether respiratory nursing interventions can improve respiratory outcomes in patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Exacerbation Copd
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 2 May 2026to 20 Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed cases of COPD admitted for acute exacerbation according to Global Initiative for Chronic Obstructive Lung Disease.
- Adults aged > 40 years (WHO, 2023; GOLD, 2024).
- Both genders (male \& female).
- Hemodynamically stable at the time of enrollment in terms of vital signs (e.g., blood pressure > 90/60 mmHg, heart rate between 60-100 bpm) to safely undergo nursing interventions without acute risk (Jarhyan et al., 2021).
- Dyspnea Grade ≥ 2 on the mMRC Scale (Mahler and Wells, 1988).
- Blood Oxygen Saturation (SpO₂) ≥ 88% on Room Air or Oxygen Therapy (O'Driscoll, 2017).
Who cannot join
- Dyspnea due to cardio-pulmonary disease or other co-morbidities.
- Patients on mechanical ventilation and ICU admission.
- Patients with mental disorders.
- Patients with upper airway obstruction.
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
UHS
Lahore, Punjab Province
Samina Kausar, Phd Nursing, +923334072790, ion_uhs@uhs.edu.pk
About this study
Official title: Effectiveness of Nurse-Led Interventions on Respiratory Outcomes in Hospitalized Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Control Trial
The goal of this clinical trial is to evaluate whether respiratory nursing interventions can improve respiratory outcomes in patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). The main questions it aims to answer are:
Do respiratory nursing interventions improve dyspnea levels measured by the Modified Medical Research Council (mMRC) Dyspnea Scale? Do these interventions improve oxygen saturation and pulmonary function (FVC, FEV1, and FEV1/FVC ratio)?
Read more
Researchers will compare patients receiving respiratory nursing interventions plus routine hospital care with patients receiving routine hospital care alone to determine whether the interventions improve respiratory outcomes.
Participants will:
Undergo baseline assessment using the mMRC Dyspnea Scale, pulse oximetry, and pulmonary function tests.
Receive either respiratory nursing interventions (deep breathing exercises, chest percussion, postural drainage, and lukewarm water intake) along with routine care or routine hospital care alone.
Be reassessed after the intervention period using the same respiratory outcome measures.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder and a leading cause of morbidity and mortality globally. In Pakistan, the prevalence of COPD is increasing due to factors such as tobacco smoking, environmental pollution, and the use of biomass fuels. Patients hospitalized with acute exacerbation of COPD often experience worsening respiratory symptoms including dyspnea, reduced oxygen saturation, and impaired pulmonary function.
Respiratory nursing interventions such as deep breathing exercises, chest percussion, postural drainage, and adequate hydration through lukewarm water intake have been reported in international literature to improve airway clearance, enhance ventilation, and support better respiratory outcomes. Despite this evidence, there is limited research conducted in Pakistan to evaluate the effectiveness of these interventions in hospitalized COPD patients.
This randomized controlled study aims to assess the add-on effects of respiratory nursing interventions on respiratory outcomes among patients with acute exacerbation of COPD. A total of 68 patients will be recruited through convenience sampling. Eligible participants will be randomly allocated into two groups: an intervention group and a control group, with 34 participants in each group, using the lottery method.
The study will be conducted in three phases: assessment, intervention, and evaluation. Baseline respiratory outcomes will be assessed prior to intervention. Participants in the intervention group will receive respiratory nursing interventions in addition to routine hospital care, while the control group will receive routine hospital care only. Outcomes will be measured using the Modified Medical Research Council (mMRC) Dyspnea Scale, pulse oximetry, and pulmonary function tests including FVC, FEV1, and FEV1/FVC ratio. Data will be analyzed using an independent t-test to determine the effectiveness of the respiratory nursing interventions.
- Conditions
- Acute Exacerbation Copd
- Being tested
- Experimental group will receive nursing interventions such as deep breathing exercise, chest percussions along with standard care.
- Keywords
- Nursing Intervention, COPD, Acute Exacerbation, Respiratory outcomes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group will receive nursing interventions such as deep breathing exercise, chest percussions along with standard care.Other
The intervention consists of a structured package of respiratory nursing interventions provided in addition to routine hospital care for patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It includes deep breathing exercises, chest percussion, postural drainage, and lukewarm water intake, administered by trained nursing staff according to a standardized protocol during hospitalization. These combined interventions aim to enhance airway clearance, improve ventilation, and reduce mucus viscosity, thereby improving dyspnea, oxygen saturation, and pulmonary function outcomes. The integration of multiple respiratory nursing techniques as an add-on to routine care distinguishes this intervention from standard management practices.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Control arm will receive standard care only. |
| Experimental Group will receive nursing intervention | Experimental | Experimental Group will receive nursing interventions such as deep breathing exercise, chest percussions, postural drainage and lukewarm water intake along with standard care Receives: Other: Experimental group will receive nursing interventions such as deep breathing exercise, chest percussions along with standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dyspnea Severity
Change in dyspnea severity measured using the Modified Medical Research Council Dyspnea Scale to assess the dyspnea affecting functioning in patients with acute exacerbation of Chronic Obstructive Pulmonary Disease. 0-5 Scale (0 Minimal functioning impairment and 4 maximum functioning impairment)
Measured: Baseline to Day 4 of hospitalization or at discharge if earlier.
Change in Pulmonary Function
Change in pulmonary function parameters including Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), and FEV1/FVC ratio measured using pulmonary function tests to determine the impact of respiratory nursing interventions in COPD patients with acute exacerbation. Normal is greater than 70%. Less than 70% means decreased pulmonary function.
Measured: Baseline to Day 4 of hospitalization or at discharge if earlier.
Secondary outcomes (1)
Change in Oxygen Saturation (SpO₂)
Change in oxygen saturation levels measured by pulse oximetry to evaluate the impact of respiratory nursing interventions on oxygenation status in patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease. Low Saturation Less than 88% and Normal greater than 95%.
Measured: Baseline to Day 4 of hospitalization or at discharge if earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start2 May 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion20 Oct 2026 (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 Acute Exacerbation CopdStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Misha Mazhar, University of Health Sciences Lahore
- Investigators
- Samina Kausar, Phd Nursing, Study director, UHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484178
- Sponsor's protocol ID
- UHS/DPS-26/575
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu X, Zhang H, Chen J. Comprehensive expectoration nursing in elderly patients with pulmonary infection and its influence on respiratory function. Am J Transl Res. 2021 Nov 15;13(11):12965-12972. eCollection 2021.
PubMed 34956512
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nurse-Led Interventions on Respiratory Outcomes in Hospitalized Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07484178
- Acronym / sponsor ID
- UHS/DPS-26/575
- Conditions
- Acute Exacerbation Copd
- Keywords
- Nursing Intervention, COPD, Acute Exacerbation, Respiratory outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 2 May 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
The goal of this clinical trial is to evaluate whether respiratory nursing interventions can improve respiratory outcomes in patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). The main questions it aims to answer are:
Do respiratory nursing interventions improve dyspnea levels measured by the Modified Medical Research Council (mMRC) Dyspnea Scale? Do these interventions improve oxygen saturation and pulmonary function (FVC, FEV1, and FEV1/FVC ratio)?
Researchers will compare patients receiving respiratory nursing interventions plus routine hospital care with patients receiving routine hospital care alone to determine whether the interventions improve respiratory outcomes.
Participants will:
Undergo baseline assessment using the mMRC Dyspnea Scale, pulse oximetry, and pulmonary function tests.
Receive either respiratory nursing interventions (deep breathing exercises, chest percussion, postural drainage, and lukewarm water intake) along with routine care or routine hospital care alone.
Be reassessed after the intervention period using the same respiratory outcome measures.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory disorder and a leading cause of morbidity and mortality globally. In Pakistan, the prevalence of COPD is increasing due to factors such as tobacco smoking, environmental pollution, and the use of biomass fuels. Patients hospitalized with acute exacerbation of COPD often experience worsening respiratory symptoms including dyspnea, reduced oxygen saturation, and impaired pulmonary function.
Respiratory nursing interventions such as deep breathing exercises, chest percussion, postural drainage, and adequate hydration through lukewarm water intake have been reported in international literature to improve airway clearance, enhance ventilation, and support better respiratory outcomes. Despite this evidence, there is limited research conducted in Pakistan to evaluate the effectiveness of these interventions in hospitalized COPD patients.
This randomized controlled study aims to assess the add-on effects of respiratory nursing interventions on respiratory outcomes among patients with acute exacerbation of COPD. A total of 68 patients will be recruited through convenience sampling. Eligible participants will be randomly allocated into two groups: an intervention group and a control group, with 34 participants in each group, using the lottery method.
The study will be conducted in three phases: assessment, intervention, and evaluation. Baseline respiratory outcomes will be assessed prior to intervention. Participants in the intervention group will receive respiratory nursing interventions in addition to routine hospital care, while the control group will receive routine hospital care only. Outcomes will be measured using the Modified Medical Research Council (mMRC) Dyspnea Scale, pulse oximetry, and pulmonary function tests including FVC, FEV1, and FEV1/FVC ratio. Data will be analyzed using an independent t-test to determine the effectiveness of the respiratory nursing interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Control arm will receive standard care only. |
| Experimental Group will receive nursing intervention | Experimental | Other: Experimental group will receive nursing interventions such as deep breathing exercise, chest percussions along with standard care.Experimental Group will receive nursing interventions such as deep breathing exercise, chest percussions, postural drainage and lukewarm water intake along with standard care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed cases of COPD admitted for acute exacerbation according to Global Initiative for Chronic Obstructive Lung Disease.
- Adults aged > 40 years (WHO, 2023; GOLD, 2024).
- Both genders (male \& female).
- Hemodynamically stable at the time of enrollment in terms of vital signs (e.g., blood pressure > 90/60 mmHg, heart rate between 60-100 bpm) to safely undergo nursing interventions without acute risk (Jarhyan et al., 2021).
- Dyspnea Grade ≥ 2 on the mMRC Scale (Mahler and Wells, 1988).
Key exclusion criteria (4 listed)
- Dyspnea due to cardio-pulmonary disease or other co-morbidities.
- Patients on mechanical ventilation and ICU admission.
- Patients with mental disorders.
- Patients with upper airway obstruction.
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 |
|---|---|---|
| Experimental group will receive nursing interventions such as deep breathing exercise, chest percussions along with standard care.The intervention consists of a structured package of respiratory nursing interventions provided in addition to routine hospital care for patients hospitalized with acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It includes deep breathing exercises, chest percussion, postural drainage, and lukewarm water intake, administered by trained nursing staff according to a standardized protocol during hospitalization. These combined interventions aim to enhance airway clearance, improve ventilation, and reduce mucus viscosity, thereby improving dyspnea, oxygen saturation, and pulmonary function outcomes. The integration of multiple respiratory nursing techniques as an add-on to routine care distinguishes this intervention from standard management practices. | Other | Experimental Group will receive nursing intervention |
Primary outcome
Change in Dyspnea Severity
Time frame: Baseline to Day 4 of hospitalization or at discharge if earlier.
Change in dyspnea severity measured using the Modified Medical Research Council Dyspnea Scale to assess the dyspnea affecting functioning in patients with acute exacerbation of Chronic Obstructive Pulmonary Disease. 0-5 Scale (0 Minimal functioning impairment and 4 maximum functioning impairment)
Change in Pulmonary Function
Time frame: Baseline to Day 4 of hospitalization or at discharge if earlier.
Change in pulmonary function parameters including Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), and FEV1/FVC ratio measured using pulmonary function tests to determine the impact of respiratory nursing interventions in COPD patients with acute exacerbation. Normal is greater than 70%. Less than 70% means decreased pulmonary function.
1 secondary outcome
Change in Oxygen Saturation (SpO₂)
Time frame: Baseline to Day 4 of hospitalization or at discharge if earlier.
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 15 Apr 2026.
- Results publication: PubMed 34956512Wu X, Zhang H, Chen J. Comprehensive expectoration nursing in elderly patients with pulmonary infection and its influence on respiratory function. Am J Transl Res. 2021 Nov 15;13(11):12965-12972. eCollection 2021.
- Management of severe acute exacerbations of COPD: an updated narrative reviewLink provided by the sponsor.
- 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.
Samina Kausar, Phd Nursing study director
UHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Acute Exacerbation Copd, run by University of Health Sciences Lahore 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 6 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 15 Apr 2026. 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 Misha Mazhar, MSN (+923026958223, mishamazhar786@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dyspnea Severity (time frame: Baseline to Day 4 of hospitalization or at discharge if earlier.). 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 NCT07484178, 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 15 Apr 2026.