Chronic Obstructive Pulmonary Disease (COPD)NCT06966063
Additive Effects of 4-7-8 Breathing Technique With Standard Management on Dyspnea, Pulmonary Function and Quality of Life in Patients With COPD.
A study testing 4-7-8 breathing along with standard management. in people with Chronic Obstructive Pulmonary Disease (COPD) and Dyspnea, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
A heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Dyspnea
- What is being tested?
- 4-7-8 breathing along with standard management.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2024to 1 Jul 2025
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults: aged (40-64 years)
- Gender: Both males and females
- Grade1- Grade 1-3 on Modified MRC dyspnea scale
- COPD mild and moderate according to GOLD classification
- Mild: FEV1 > 80% predicted
- Moderate: FEV1 >50% predicted
Who cannot join
- Severe and very severe stage of COPD according to GOLD classification.
- Patients having Acute exacerbation of COPD.
- Patients diagnosed with acute infections.
- Patients unable to follow commands/ instructions.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Islamabad, 44000
About this study
A heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction.
Breathing exercises help to manage dyspnea and reduced pulmonary function often seen in COPD patients. To handle respiratory complications COPD patients are advised to practice breathing techniques in conjunction with their prescribed medications.
Read the detailed description
COPD is a very common chronic respiratory disease with symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction.
Breathing exercises help to manage dyspnea associated with COPD. In order to manage respiratory conditions COPD patients are encouraged for nasal breathing techniques along with standard management. Hence the objective of the study is to compare the effects of 4-7-8 breathing along with standard management versus standard management alone on dyspnea, pulmonary function, and quality of life in patients with COPD.
- Being tested
- 4-7-8 breathing along with standard management., Control Group
- Keywords
- Dyspnea, pulmonary function, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-7-8 breathing along with standard management.Procedure or surgery
For 4-7-8 breathing, Patient is asked sit in comfortable position. Patient is asked place the tip of your tongue up against the back of your front teeth. Keep it there through the entire breathing process. Instruct the patient to breathe in silently through your nose to the count of four (4sec) and Hold your breath to the count of seven (7sec). Exhale through your mouth to the count of eight (8sec), making an audible "whoosh" sound. That completes one full breath. Repeat the cycle another three time, and gradually in increase the cycle four time.
Total 4 weeks protocol. Two sessions per week will be supervised by physiotherapist and 5 days at home. Week 01 and 02 Frequenc: 01 session/day Intensity: Start with comfortable duration. Time: 10 minutes Week 03 and 04 Frequecy: 02 sessions/day Intensity: 4 sec inhale, 7 sec hold and 8 sec exhale Time: 15 minutes
Control GroupProcedure or surgery
Patients will recieve medication as prescribed by pulmonologist through stepwise approach according to symptoms and severity.
Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken.
Week 01 and 02 Patients will receive medications prescribed by pulmonologist. Week 03 and 04 Patients will receive medications prescribed by pulmonologist.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Patients in interventional group will recieve 4-7-8 breathing along with standard management.
For 4-7-8 breathing, Patient is asked sit in comfortable position. Patient is asked place the tip of your tongue up against the back of your front teeth. Keep it there through the entire breathing process. Instruct the patient to breathe in silently through your nose to the count of four (4sec) and Hold your breath to the count of seven (7sec). Exhale through your mouth to the count of eight (8sec), making an audible "whoosh" sound. That completes one full breath. Repeat the cycle another three time, and gradually in increase the cycle four time.
Total 4 weeks protocol. Two sessions per week will be supervised by physiotherapist and 5 days at home. A home diary will be provided in order to ensure and follow-up that participants are performing breathing exercise at home along with medications prescribed by pulmonologist. Receives: Procedure: 4-7-8 breathing along with standard management. |
| Control group | Active comparator | Patients will receive medication as prescribed by pulmonologist through stepwise approach according to symptoms and severity.
Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken.
Week 01 and 02 Patients will receive medications prescribed by pulmonologist. Week 03 and 04 Patients will receive medications prescribed by pulmonologist. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea
Evaluation will be done using Dyspnea-12 questionnaire for dyspnea
Measured: 4 weeks
pulmonary function
spirometer to measure volume of air inspired and exhale through lungs.
Measured: 4 weeks
Quality of Life of COPD patients
COPD assessment test (CAT) will be used to evaluate quality of life of COPD patients
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 posted11 May 2025
- Study start15 Jun 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966063
- Sponsor's protocol ID
- FUI/CTR/2024/69
- Status last verified
- Sep 2025
- First submitted
- 2 May 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effects of 4-7-8 Breathing Technique With Standard Management on Dyspnea, Pulmonary Function and Quality of Life in Patients With COPD.
- ClinicalTrials.gov ID
- NCT06966063
- Acronym / sponsor ID
- FUI/CTR/2024/69
- Keywords
- Dyspnea, pulmonary function, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 11 May 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.
A heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction.
Breathing exercises help to manage dyspnea and reduced pulmonary function often seen in COPD patients. To handle respiratory complications COPD patients are advised to practice breathing techniques in conjunction with their prescribed medications.
Detailed description
COPD is a very common chronic respiratory disease with symptoms (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema)-- cause persistent, often progressive, airflow obstruction.
Breathing exercises help to manage dyspnea associated with COPD. In order to manage respiratory conditions COPD patients are encouraged for nasal breathing techniques along with standard management. Hence the objective of the study is to compare the effects of 4-7-8 breathing along with standard management versus standard management alone on dyspnea, pulmonary function, and quality of life in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Procedure: 4-7-8 breathing along with standard management.Patients in interventional group will recieve 4-7-8 breathing along with standard management. For 4-7-8 breathing, Patient is asked sit in comfortable position. Patient is asked place the tip of your tongue up against the back of your front teeth. Keep it there through the entire breathing process. Instruct the patient to breathe in silently through your nose to the count of four (4sec) and Hold your breath to the count of seven (7sec). Exhale through your mouth to the count of eight (8sec), making an audible "whoosh" sound. That completes one full breath. Repeat the cycle another three time, and gradually in increase the cycle four time. Total 4 weeks protocol. Two sessions per week will be supervised by physiotherapist and 5 days at home. A home diary will be provided in order to ensure and follow-up that participants are performing breathing exercise at home along with medications prescribed by pulmonologist. |
| Control group | Active comparator | Procedure: Control GroupPatients will receive medication as prescribed by pulmonologist through stepwise approach according to symptoms and severity. Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken. Week 01 and 02 Patients will receive medications prescribed by pulmonologist. Week 03 and 04 Patients will receive medications prescribed by pulmonologist. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults: aged (40-64 years)
- Gender: Both males and females
- Grade1- Grade 1-3 on Modified MRC dyspnea scale
- COPD mild and moderate according to GOLD classification
- Mild: FEV1 > 80% predicted
Key exclusion criteria (4 listed)
- Severe and very severe stage of COPD according to GOLD classification.
- Patients having Acute exacerbation of COPD.
- Patients diagnosed with acute infections.
- Patients unable to follow commands/ instructions.
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 |
|---|---|---|
| 4-7-8 breathing along with standard management.For 4-7-8 breathing, Patient is asked sit in comfortable position. Patient is asked place the tip of your tongue up against the back of your front teeth. Keep it there through the entire breathing process. Instruct the patient to breathe in silently through your nose to the count of four (4sec) and Hold your breath to the count of seven (7sec). Exhale through your mouth to the count of eight (8sec), making an audible "whoosh" sound. That completes one full breath. Repeat the cycle another three time, and gradually in increase the cycle four time. Total 4 weeks protocol. Two sessions per week will be supervised by physiotherapist and 5 days at home. Week 01 and 02 Frequenc: 01 session/day Intensity: Start with comfortable duration. Time: 10 minutes Week 03 and 04 Frequecy: 02 sessions/day Intensity: 4 sec inhale, 7 sec hold and 8 sec exhale Time: 15 minutes | Procedure or surgery | Interventional group |
| Control GroupPatients will recieve medication as prescribed by pulmonologist through stepwise approach according to symptoms and severity. Total 4 weeks protocol. Before and after 4 weeks pre and post interventional values will be taken. Week 01 and 02 Patients will receive medications prescribed by pulmonologist. Week 03 and 04 Patients will receive medications prescribed by pulmonologist. | Procedure or surgery | Control group |
Primary outcome
Dyspnea
Time frame: 4 weeks
Evaluation will be done using Dyspnea-12 questionnaire for dyspnea
pulmonary function
Time frame: 4 weeks
spirometer to measure volume of air inspired and exhale through lungs.
Quality of Life of COPD patients
Time frame: 4 weeks
COPD assessment test (CAT) will be used to evaluate quality of life of COPD patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-7-8 breathing along with standard management. in people with Chronic Obstructive Pulmonary Disease (COPD) and Dyspnea, run by Foundation University Islamabad 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: finished, as of the sponsor's last update on 15 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (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 15 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.