NCT06609941

Brief 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. To handle respiratory complications asthmatics are advised to practise nasal breathing techniques in conjunction with their prescribed medications.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

September 24, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

September 20, 2024

Last Update Submit

September 20, 2024

Conditions

Keywords

Dyspnea, asthma control, peak expiratory flow rate

Outcome Measures

Primary Outcomes (4)

  • Dyspnea

    Evaluation will be done using Dyspnea-12 questionnaire for dyspnea

    4 weeks

  • Control pause

    Stopwatch will be used to measure control pause.

    4 weeks

  • Asthma control

    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.

    Peak flow meter will be used to measure peak expiratory flow rate

    4 Weeks

Study Arms (2)

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.

Other: Alternative nostril breathingDrug: 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.

Drug: Pharmacological therapy

Interventions

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.

Nostril Breathing along with pharmacological therapy Group

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.

Nostril Breathing along with pharmacological therapy GroupPharmacological therapy Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

AsthmaDyspnea

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Bazkha Tariq Aslam Khawaja, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

June 18, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

September 24, 2024

Record last verified: 2024-08

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