Impact of Chewing Gum on FeNO Levels in Patients With Bronchial Asthma

NCT07053956 | Completed

• 1 other identifier: 24-515
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to investigate the influence of chewing gum consumption on FeNO levels in asthma patients in order to avoid systematic errors in treatment decisions.

Conditions

Asthma Bronchiale; FeNO; Chewing Gum

Keywords

Asthma bronchiale; FeNO; Chewing Gum

Outcome Measures

Primary Outcomes (1)

• FeNO measurement after 15 minutes of consuming sugar-free, antioxidant-containing chewing gum

  FeNO measurement is measured again after 15 minutes of consuming sugar-free, antioxidant-containing chewing gum

  15 Minutes

Study Arms (2)

Chewing gum arm

ACTIVE COMPARATOR

Patients admitted to our outpatient clinic for bronchial asthma undergo regular FeNO measurements. If the value is ≥ 25 ppb (elevated), the patients are randomized into two groups after obtaining their consent. In the control group, a FeNO measurement is performed again after 15 minutes. In the second group, the FeNO measurement is measured again after 15 minutes of consuming sugar-free, antioxidant-containing chewing gum. The following data are then collected and documented from the patients: age, gender, height, weight, smoking status, current medication, other illnesses, whole body lung function test, and laboratory tests (eosinophils, IgE). Participation in the study will not change the course of the patient's stay in our clinic.

Other: Chewing Gum

Control arm

SHAM COMPARATOR

Patients admitted to our outpatient clinic for bronchial asthma undergo regular FeNO measurements. If the value is ≥ 25 ppb (elevated), the patients are randomized into two groups after obtaining their consent. In the control group, a FeNO measurement is performed again after 15 minutes. In the second group, the FeNO measurement is measured again after 15 minutes of consuming sugar-free, antioxidant-containing chewing gum. The following data are then collected and documented from the patients: age, gender, height, weight, smoking status, current medication, other illnesses, whole body lung function test, and laboratory tests (eosinophils, IgE). Participation in the study will not change the course of the patient's stay in our clinic.

Other: Chewing Gum

Interventions

Chewing Gum OTHER

Patients admitted to our outpatient clinic for bronchial asthma undergo regular FeNO measurements. If the value is ≥ 25 ppb (elevated), the patients are randomized into two groups after obtaining their consent. In the control group, a FeNO measurement is performed again after 15 minutes. In the second group, the FeNO measurement is measured again after 15 minutes of consuming sugar-free, antioxidant-containing chewing gum. The following data are then collected and documented from the patients: age, gender, height, weight, smoking status, current medication, other illnesses, whole body lung function test, and laboratory tests (eosinophils, IgE). Participation in the study will not change the course of the patient's stay in our clinic.

Chewing gum arm; Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have known bronchial asthma with a FeNO level ≥25 ppb at regular medical checkups
• are of legal age
• are mentally and physically capable of understanding the significance and scope of the study and obeying the instructions of study personnel
• are legally competent and have signed the informed consent form.

You may not qualify if:

• Current or past medically relevant illness or treatment that could impact the evaluability of the study.
• FeNO levels \< 25 ppb
• Medical contraindications to conducting FeNO measurements
• Expected unwillingness to actively participate in study-related measures.
• Known allergies or intolerances to the contents of chewing gum
• Smoking, alcohol consumption, mouthwash use, chewing gum/candy/lettuce/spinach/kale/beetroot/radish/sausage consumption, or exercise on the day of the study.

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (2)

University Hospital Aachen

Aachen, Aachen, 52074, Germany

Location

Department of Pneumology and Intensive Care Medicine, RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Interventions

Chewing Gum

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dr. Maria Aetou Aetou

  RWTH Aachen University Hospital

  PRINCIPAL INVESTIGATOR

• Professor Michael Dreher Dreher

  RWTH Aachen University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Single-center interventional randomized case-controlled study

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: August 1, 2025
• Primary Completion: December 17, 2025
• Study Completion: December 23, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Until further notice

Locations

DE (2)