Bronchial AsthmaNCT06609941
Additive Effects of Alternative Nostril Breathing with Pharmacological Management on Dyspnea and Control Pause in Patients with Bronchial Asthma
A study testing Alternative nostril breathing and Pharmacological therapy in people with Bronchial Asthma, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Bronchial asthma is a widespread chronic condition charactrized by inflammation and narrowing of airways, leading to repeateted episodes of breathlessness, wheezing and labored breathing.Breathing exercises help to manage hyperventilation often seen in asthmatic patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Alternative nostril breathing and Pharmacological therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jun 2024to 1 Feb 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults: aged (18-45 years)
- Gender: Both males and females
- Grade1- Grade 4 on Modified MRC dyspnea scale
- Asthma severity classes (intermediate, mild persistent and moderate persistent asthma) acc. to NAEPP national asthma education and prevention program guidlin
Who cannot join
- Patients having acute exacerbation of COPD or status asthmaticus
- Patients diagnosed with acute infections
- Patients unable to follow command/ instructions
- Asthma patients with >40 sec control pause duration
- Patients who fall in red zone of asthma action plan (PEFR < 50%)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, Punjab Province, 46000
Zara Khalid, DPT, MS-CPPT,PHD, 0333-5415822, zara.khalid@fui.edu.pk
About this study
Bronchial asthma is a widespread chronic condition charactrized by inflammation and narrowing of airways, leading to repeateted episodes of breathlessness, wheezing and labored breathing.Breathing exercises help to manage hyperventilation often seen in asthmatic patients. To handle respiratory complications asthmatics are advised to practise nasal breathing techniques in conjunction with their prescribed medications.
Read the detailed description
Bronchial asthma is a very common chronic disease marked by inflammation and constriction of airways, resulting in recurrent episodes of breathlessness, wheezing and decrease work of breathing. Breathing exercises help to manage hyperventilation associated with asthma. In order to manage respiratory conditions asthmatic patients are encouraged for nasal breathing techniques along with pharmacological management. Hence the objective of the study is to compare the effects of alternative nostril breathing along with pharmacological management versus pharmacological management alone on dyspnea, control pause, asthma control and peak expiratory flow rate in patients with bronchial asthma.
- Conditions
- Bronchial Asthma
- Being tested
- Alternative nostril breathing, Pharmacological therapy
- Keywords
- Dyspnea, asthma control, peak expiratory flow rate
- Medical subject headings
- Asthma, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative nostril breathingOther
Patients in this group will receive alternative nostril breathing along with pharmacological management. For alternative nostirl breathing patient will be advised to inhale slowly (4sec) and deeply through left nostril.Then hold breath for 2-3 sec. Release right nostril and use right ring finger to close left nostril. Exhale slowly (6sec) and completely through right nostril. Inhale slowly (4sec) and deeply through right nostril. Then hold breath for 2-3sec. Release left nostril and use right thumb to close right nostril. Exhale slowly (6sec) and completely through left nostril. Repeat the cycle.
Pharmacological therapyDrug
Participants in this group will only be provided with standard pharmacological management for 4 weeks as prescribed by a pulmonologist. For example:
Salbutamol inhaler (Short acting bronchodilator) Saltra inhaler (Selective long acting β2 adrenoceptor agonist) Tiotropium (Anticholinergic) Combivir (Nucleoside analogue - reverse transcriptase inhibitor) etc.
Week 01 and week 02:
Patients will receive medication prescribed by pulmonologist.
Week 03 and week 04:
Patients will receive medication prescribed by pulmonologist.
| Study group | Role | What they receive |
|---|---|---|
| Nostril Breathing along with pharmacological therapy Group | Experimental | Patients in this group will receive alternative nostril breathing along with pharmacological management.
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. Receives: Other: Alternative nostril breathing; Drug: Pharmacological therapy |
| Pharmacological therapy 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. Receives: Drug: Pharmacological therapy |
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
Control pause
Stopwatch will be used to measure control pause.
Measured: 4 weeks
Asthma control
Asthma control test (ACT) will be used to evaluate asthma control and peak flow meter for peak expiratory flow rate.
Measured: 4 weeks
Peak expiratory flow rate.
Peak flow meter will be used to measure peak expiratory flow rate
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 posted24 Sep 2024
- Study start18 Jun 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies 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
- Model description
- This is a randomized controlled trial having two groups. One group will receive (interventional group) alternative nostril breathing along with pharmacological management and the other group (control group) will receive only pharmacological management.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609941
- Sponsor's protocol ID
- FUI/CTR/2024/25
- Status last verified
- Aug 2024
- First submitted
- 20 Sep 2024
- Last updated
- 24 Sep 2024
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effects of Alternative Nostril Breathing with Pharmacological Management on Dyspnea and Control Pause in Patients with Bronchial Asthma
- ClinicalTrials.gov ID
- NCT06609941
- Acronym / sponsor ID
- FUI/CTR/2024/25
- Conditions
- Bronchial Asthma
- Keywords
- Dyspnea, asthma control, peak expiratory flow rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 24 Sep 2024 (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.
Bronchial asthma is a widespread chronic condition charactrized by inflammation and narrowing of airways, leading to repeateted episodes of breathlessness, wheezing and labored breathing.Breathing exercises help to manage hyperventilation often seen in asthmatic patients. To handle respiratory complications asthmatics are advised to practise nasal breathing techniques in conjunction with their prescribed medications.
Detailed description
Bronchial asthma is a very common chronic disease marked by inflammation and constriction of airways, resulting in recurrent episodes of breathlessness, wheezing and decrease work of breathing. Breathing exercises help to manage hyperventilation associated with asthma. In order to manage respiratory conditions asthmatic patients are encouraged for nasal breathing techniques along with pharmacological management. Hence the objective of the study is to compare the effects of alternative nostril breathing along with pharmacological management versus pharmacological management alone on dyspnea, control pause, asthma control and peak expiratory flow rate in patients with bronchial asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial having two groups. One group will receive (interventional group) alternative nostril breathing along with pharmacological management and the other group (control group) will receive only pharmacological management.
| Arm | Type | Receives |
|---|---|---|
| Nostril Breathing along with pharmacological therapy Group | Experimental | Other: Alternative nostril breathing, Drug: Pharmacological therapyPatients in this group will receive alternative nostril breathing along with pharmacological management. 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. |
| Pharmacological therapy Group | Active comparator | Drug: Pharmacological therapyPatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults: aged (18-45 years)
- Gender: Both males and females
- Grade1- Grade 4 on Modified MRC dyspnea scale
- Asthma severity classes (intermediate, mild persistent and moderate persistent asthma) acc. to NAEPP national asthma education and prevention program guidlin
Key exclusion criteria (5 listed)
- Patients having acute exacerbation of COPD or status asthmaticus
- Patients diagnosed with acute infections
- Patients unable to follow command/ instructions
- Asthma patients with >40 sec control pause duration
- Patients who fall in red zone of asthma action plan (PEFR < 50%)
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 |
|---|---|---|
| Alternative nostril breathingPatients in this group will receive alternative nostril breathing along with pharmacological management. For alternative nostirl breathing patient will be advised to inhale slowly (4sec) and deeply through left nostril.Then hold breath for 2-3 sec. Release right nostril and use right ring finger to close left nostril. Exhale slowly (6sec) and completely through right nostril. Inhale slowly (4sec) and deeply through right nostril. Then hold breath for 2-3sec. Release left nostril and use right thumb to close right nostril. Exhale slowly (6sec) and completely through left nostril. Repeat the cycle. | Other | Nostril Breathing along with pharmacological therapy Group |
| Pharmacological therapyParticipants in this group will only be provided with standard pharmacological management for 4 weeks as prescribed by a pulmonologist. For example: Salbutamol inhaler (Short acting bronchodilator) Saltra inhaler (Selective long acting β2 adrenoceptor agonist) Tiotropium (Anticholinergic) Combivir (Nucleoside analogue - reverse transcriptase inhibitor) etc. Week 01 and week 02: Patients will receive medication prescribed by pulmonologist. Week 03 and week 04: Patients will receive medication prescribed by pulmonologist. | Drug | Nostril Breathing along with pharmacological therapy Group, Pharmacological therapy Group |
Primary outcome
Dyspnea
Time frame: 4 weeks
Evaluation will be done using Dyspnea-12 questionnaire for dyspnea
Control pause
Time frame: 4 weeks
Stopwatch will be used to measure control pause.
Asthma control
Time frame: 4 weeks
Asthma control test (ACT) will be used to evaluate asthma control and peak flow meter for peak expiratory flow rate.
Peak expiratory flow rate.
Time frame: 4 Weeks
Peak flow meter will be used to measure peak expiratory flow rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative nostril breathing and Pharmacological therapy in people with Bronchial Asthma, 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 4 inclusion and 5 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 24 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bazkha Tariq Aslam Khawaja, DPT (0333-1281293, bazkhatariq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: 4 weeks). The study lists 4 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 24 Sep 2024.