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Study on the Effect of Xylometazoline Nasal Spray on Physical Capacity in Adults with Chronic Obstructive Pulmonary Disease (COPD)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a nasal spray treatment for individuals with Chronic Obstructive Pulmonary Disease (COPD). The treatment being tested is a nasal spray containing oxymetazoline, which is also known by the brand name Otrivin®. The purpose of the study is to assess how a single dose of this nasal spray affects the physical capacity of people living with COPD.

Participants in the study will receive one dose of the nasal spray, and the main focus will be on observing any changes in their ability to perform physical activities. The study will measure the distance participants can walk and use a scale called the Borg scale to evaluate their level of exertion or breathlessness during physical activity. The study aims to provide insights into whether this nasal spray can help improve the physical capabilities of those with COPD.

The trial is designed to include both males and females aged between 18 and 64 years who have been diagnosed with COPD according to standard criteria. The study will take place over a period of time, with the goal of understanding the potential benefits of using oxymetazoline nasal spray for improving the quality of life for individuals with COPD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to assess the effect of a single dose of oxymetazoline nasal spray (Otrivin®) on your physical capacity if you have Chronic Obstructive Pulmonary Disease (COPD).
Step 2
Receiving the medication
You will receive a single dose of oxymetazoline nasal spray. This medication is administered as a nasal spray, which means it is sprayed into your nose. The dosage is 1 mg/ml, and it is given only once during the study.
Step 3
Physical capacity assessment
After receiving the nasal spray, your physical capacity will be assessed. This involves measuring the distance you can walk. This is the primary endpoint of the study, meaning it is the main outcome being measured.
Step 4
Secondary assessment
In addition to the walking distance, your perceived exertion will be evaluated using the Borg scale. This scale helps to measure how hard you feel your body is working during physical activity.
Step 5
Completion of the study
Once the assessments are completed, your participation in the study will conclude. The study is expected to end by January 1, 2026.

Who can join the trial?

3 criteria

Participants must have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to the standard guidelines known as the GOLD standard.
Participants can be of any gender, both male and female are eligible.
Participants must be adults, which means they should be 18 years or older.

Who cannot join the trial?

3 criteria

Patients who do not have Chronic Obstructive Pulmonary Disease (COPD) cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Akershus University Hospital
Lorenskog, Norway

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Investigated drugs

Oxymetazoline Nasal Spray (Otrivin®) is a medication used in this clinical trial to help improve the physical capacity of people with Chronic Obstructive Pulmonary Disease (COPD). It is a nasal spray that works by narrowing the blood vessels in the nose, which helps to reduce swelling and congestion. This can make breathing easier and may help patients with COPD to be more active. The trial is studying the effects of a single dose of this nasal spray on the physical abilities of both men and women aged 18 to 64 who have COPD.

XYLOMETAZOLINE HYDROCHLORIDE

What is already known about the treatment

Otrivin® – Otrivin® is a nasal spray administered directly into the nostrils to help improve breathing. It is currently being studied in a phase 4 clinical trial to evaluate its effects on physical capacity in individuals with Chronic Obstructive Pulmonary Disease (COPD). The main therapeutic use of Otrivin® is to relieve nasal congestion, which can help improve airflow and breathing. At the molecular level, it works by constricting blood vessels in the nasal passages, reducing swelling and congestion. Otrivin® is classified as a decongestant in pharmacology.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. It is characterized by a persistent blockage of airflow from the lungs. The disease progresses slowly and involves the gradual destruction of lung tissue, leading to symptoms such as chronic cough, mucus production, and shortness of breath. Over time, the airways become inflamed and narrowed, and the lung tissue loses its elasticity. This results in decreased airflow and difficulty in expelling air from the lungs. As the disease advances, physical activities may become increasingly challenging due to reduced lung function.