AuthorisedTherapeutic confirmatory (Phase III)Interventional

A single group treatment, phase 4, study to assess the effect of 1 dose with oxymetazoline nasal spray(Otrivin®) on physical capacity of males and females aged 18 and 64 years suffering from Chronic Obstructive Pulmonary Disease (COPD)

This study is testing a common nose spray called Otrivin (which contains oxymetazoline) to see if it can help people with Chronic Obstructive Pulmonary Disease (COPD). Researchers want to find out if using this spray can make it easier for people with COPD to breathe, and in turn, improve how far they can walk. The study involves giving one dose of the spray and then measuring changes in walking distance. It's open to both men and women aged 18 and older who have COPD. The main goal is to understand if this simple treatment could help people with COPD be more active in their daily lives.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sorlandet Sykehus HF

Enrolment target

Start

24 Jan 2025

Chronic Obstructive Plumonary Disease (COPD)

What is this study about?

This study is looking into a nose spray called Otrivin (which has a medicine called oxymetazoline in it) and how it might affect people who have a lung condition called Chronic Obstructive Pulmonary Disease, or COPD. COPD makes it harder to breathe, especially during physical activity. The researchers want to see if using this nose spray just once can help people with COPD walk further and feel less breathless.

The main idea behind the study is that conditions like COPD can sometimes be made worse by blocked or congested nasal passages. If the nose spray can clear up the nose, it might make breathing through the nose easier, and this could then help the lungs work a bit better, especially during exercise. This is a "Phase III" study, which means the treatment has already been tested safely in earlier stages, and now researchers are confirming how well it works.

To measure if the spray helps, the study will mainly look at how far participants can walk after using it. They will also use a special scale (called the Borg scale) to see if people feel less breathless or tired. The results of this study could help doctors understand if a simple nose spray could be a helpful addition to the care of people living with COPD, potentially making their daily activities a little easier.

Key takeaways

This study explores if a common nose spray helps people with COPD.
It aims to see if the spray improves how far someone can walk.
Participation involves using one dose of the nose spray.
The study is for men and women aged 18 and older with COPD.
It seeks to understand if simple nasal relief can aid breathing in COPD.

Who may be eligible?

This study is looking for volunteers who have Chronic Obstructive Pulmonary Disease (COPD). You need to be at least 18 years old to take part, and there's no upper age limit mentioned, so older adults are welcome.

Both men and women are encouraged to join the study. The main requirement is that you have a diagnosis of COPD, as the study is specifically designed to understand how the nose spray affects this condition.

Further details about your specific health condition or any other medications you take would be discussed with the study team to make sure it's safe and suitable for you to participate.

Quick self-check

Do I have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)?
Am I 18 years old or older?
Am I comfortable using a nose spray?
Am I able to walk, even if it's for a short distance?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will be given one dose of the prescribed nose spray (Otrivin). The main assessment will involve seeing how far you can walk, likely before and after using the spray, to measure any changes. You'll also be asked to rate your breathlessness using a simple scale. The study is designed to be quite straightforward, likely involving a single visit or a short period of assessment to understand the immediate effect of the spray. The study team will explain all the details, including how long your visit might be and any follow-up required.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study could be that using the nose spray might temporarily improve your breathing and walking ability. However, this is not guaranteed, and the main benefit is helping researchers learn more about COPD. Potential risks of using oxymetazoline nose spray can include temporary dryness or irritation in the nose, or in rare cases, a worsening of congestion if used for too long. You will be fully informed of all known risks before you decide to participate, and importantly, you are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Norway

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it hard to breathe, often causing coughing, wheezing, and shortness of breath.

What is Otrivin?

Otrivin is a common brand of nose spray that contains a medicine called oxymetazoline. It's used to help clear a blocked or stuffy nose.

Will I have to take the nose spray more than once?

This study is designed to look at the effect of just one dose of the nose spray. If you were to continue using it outside the study, you should follow your doctor's advice.

What is 'walking distance' and why is it important?

'Walking distance' is a simple way to measure how far you can walk in a set amount of time. It's important because it gives an idea of how well you can do daily physical activities.

Will I get paid for taking part?

The study team will be able to tell you if there is any reimbursement for travel expenses or your time when you discuss the study with them.