AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

An Open Label Study to Assess the Effect of Patient Use and Robustness on Tiotropium Bromide Spray 2.5μg, Soft Mist Inhaler device

This research study is about a particular inhaler that delivers a medicine called tiotropium bromide, used to help people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a common lung condition that makes it difficult to breathe. The study aims to understand two main things: firstly, how well the inhaler works when people use it in real-life situations, and secondly, how robust and reliable the inhaler device itself is. This is a very early stage 'Phase 1' study, which means it helps researchers learn more about the treatment and device. It's an 'open label' study, meaning both the participants and the researchers will know which treatment is being used. This information helps improve treatments for people with breathing difficulties.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Laboratorios Liconsa S.A.

Enrolment target

Start

16 Sep 2025

Chronic obstructive pulmonary disease

What is this study about?

Imagine you have a new gadget, and you want to know how well it works when people actually use it, and if it can stand up to everyday life. This study is a bit like that, but for an inhaler used by people with a common lung condition called Chronic Obstructive Pulmonary Disease, or COPD.

COPD makes it harder to breathe, and treatments often involve inhalers that deliver medicine directly to the lungs. This particular study is focusing on an inhaler that delivers a medicine called tiotropium bromide.

The main goals are to see how effectively people can use this inhaler to get their medicine, and to check how strong and dependable the inhaler device itself is. This helps scientists make sure that when a new treatment or device is used by patients, it's both effective and easy to use consistently. This kind of early research is really important to make sure new treatments are as good as they can be for patients.

Key takeaways

This study focuses on an inhaler for people with COPD.
It checks how well people use the inhaler and its durability.
It's an early-stage study to learn more about the device.
Participants must be 18 years old or over, both men and women.
Your health would be closely monitored if you take part.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also participate.

This study is open to both men and women.

Because the study is focused on a treatment for Chronic Obstructive Pulmonary Disease (COPD), participants would likely need to have a diagnosis of COPD. Specific details about the severity or type of COPD, or any other health conditions, would be provided by the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Chronic Obstructive Pulmonary Disease (COPD)?
Are you a man or a woman?
Are you able to attend study appointments as required?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be using a specific inhaler and medicine, tiotropium bromide spray 2.5μg, as directed by the study team. Both you and the researchers would know what medicine is being used. You would have regular appointments at the study site, where the research team would monitor your health and how you are using the inhaler. They might ask you to complete questionnaires or perform breathing tests. The total length of your participation in the study would be explained to you in detail by the research team.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, perhaps by giving you access to new ways of using an existing treatment for your COPD, and you would be closely monitored by medical professionals. However, there are also potential risks; side effects from the medication or device could occur, or using the inhaler in a new way might not be suitable for everyone. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a group of lung conditions that cause breathing difficulties.

What is an 'open label' study?

It means that both you and the study doctors will know which treatment you are receiving.

What is 'µg'?

It's a small measurement for the amount of medicine, standing for 'microgram'.

Is this a new medicine?

The study is looking at how a specific inhaler and an existing medicine (tiotropium bromide) work together and how sturdy the device is.

Will I have to pay to be in the study?

No, participating in a clinical trial like this generally doesn't cost you money. All study-related care and medication are usually provided free of charge.