Symptoms, Respiratory Dysfunction and Frailty Level in Allergic and Eosonophilic Asthmatics

NCT06796894 | Recruiting

• 1 other identifier: SBA 24/477
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the level of respiratory dysfunction, symptoms and frailty in patients with asthma according to different endophenotypes (allergic and eosonophilic asthma). In the light of the data obtained, it is thought that rehabilitation approaches that can be determined according to different endophenotypes in line with the evaluated parameters will guide health professionals working in this field. Hypotheses H0: There is no difference between allergic and eosonophilic asthmatics in terms of pulmonary function, respiratory dysfunction, symptoms, dyspnoea, fatigue, rhinitis, perception of breathlessness in activities of daily living, asthma control, level of frailty or quality of life. H1: There is a difference between individuals with allergic and eosonophilic asthma in terms of pulmonary function, respiratory dysfunction, symptoms, dyspnoea, fatigue, rhinitis, perception of breathlessness in activities of daily living, asthma control, level of frailty or quality of life.

Conditions

Asthma; Respiratory Disease; Fragility

Keywords

Asthma; Respiratory Dysfunction; Fragility

Outcome Measures

Primary Outcomes (1)

• Respiratory Symptoms

  The Nijmegen Questionnaire. The Nijmegen Questionnaire (NQ) gives a broad view of symptoms associated with dysfunctional breathing patterns. The NQ consists of 16 items to be answered on a five-point scale ranging from 'never' counted as zero to 'very often' counted as 4. The total score ranges from 0-64.

  One day

Secondary Outcomes (9)

• Pulmonary functions

  One day

• Dyspnea during daily life

  One day

• Asthma Control Level

  One day

• Fatigue level

  One day

• Asthma and allergic rhinit symptoms

  One day

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hacettepe University Faculty of Medicine Department of Paediatrics Patients aged 35-75 years who have been diagnosed with asthma in the Allergy and Asthma Unit and who volunteered to participate in the study will be included in the study.

You may qualify if:

• Age between 35-75 years,
• Diagnosed with allergic or eosonophilic asthma according to the Global Strategy for the Prevention and Treatment of Asthma (GINA).

You may not qualify if:

• Known cognitive impairment,
• Having had an acute asthma attack in the last 6 weeks,
• Having changed medication in the last 4 weeks.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Asthma; Respiration Disorders; Dyspnea

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebru Calik Kutukcu

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Aynur Demirel, PhD

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Ebru Calik Kutukcu, PhD

CONTACT

3123051576; ebru.calik@hacettepe.edu.tr

Hacer Oncu, MsC

CONTACT

+905422305093; haceroncu1997@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

TU (1)