Additive Effects of Alternative Nostril Breathing with Pharmacological Management on Dyspnea and Control Pause in Patients with Bronchial Asthma

September 20, 2024 updated by: Foundation University Islamabad
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Recruiting
        • Foundation University College of Physical Therapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nostril Breathing along with pharmacological therapy Group

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.
Other: Alternative nostril breathing
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.
Drug: Pharmacological therapy

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.
Active Comparator: Pharmacological therapy Group

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.
Drug: Pharmacological therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: 4 weeks
Evaluation will be done using Dyspnea-12 questionnaire for dyspnea
4 weeks
Control pause
Time Frame: 4 weeks
Stopwatch will be used to measure control pause.
4 weeks
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.
4 weeks
Peak expiratory flow rate.
Time Frame: 4 Weeks
Peak flow meter will be used to measure peak expiratory flow rate
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUI/CTR/2024/25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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