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Real-World watch: how does a daily inhaled asthma combo perform outside trials?

NCT ID NCT05217810

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are observing adolescents and adults with asthma who have been prescribed Atectura, a daily inhaled combination of indacaterol and mometasone, to see how the drug performs in routine care. The study follows about 670 participants for up to 24 weeks and records side effects, lung function, and asthma control scores. Because it is an observational study with no comparison group, it describes what happens in real-world use rather than proving cause and effect.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a daily inhaled asthma combination of indacaterol and mometasone (Atectura)
What this could lead to
If the data hold up, doctors could gain clearer real-world evidence on how well Atectura controls asthma and what side effects appear in everyday practice.
What could go wrong
This is an observational study with no comparison group, so it cannot prove the drug works. Results may reflect how patients are selected or how faithfully they use the inhaler, and rare side effects can stay hidden in a study this size.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

670 people

The number who actually took part.

Started

May 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

subjects who received at least one dose of Atectura inhalation capsule via Breezhaler and that have provided consent for their data collection.

Ages

12 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adolescent (≥12 years of age) and adult patients with a physician's diagnosis of asthma, who are prescribed Atectura inhalation capsule (indacaterol acetate/mometasone furoate; 150/80, 150/160, 150/320 μg) via Breezhaler, as per the approved label information 2. Patients who participate in the study after signing the consent form for data collection and use (Data Privacy ICF) after receiving a clear explanation of the objectives and nature of the study from the investigator (For patients under the age of 18, consent and signature of a legal representative is required) Exclusion Criteria: 1. Patients who are contraindicated for this medicinal product as described in the Precautions for Use in the label information (package insert) A. Patients with hypersensitivity reaction to this medicinal product or any of its constituents B. Because this medicinal product contains lactose, patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption, etc. 2. Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required 3. Patients participating in other interventional clinical trials

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Novartis Investigative Site

    Daegu, Dalseo gu, 42602, South Korea

  • Novartis Investigative Site

    Kangwon Do, Gangneung si, 210 711, South Korea

  • Novartis Investigative Site

    Wŏnju, Gangwon-do, 26426, South Korea

  • Novartis Investigative Site

    Goyang-si, Gyeonggi-do, 10380, South Korea

  • Novartis Investigative Site

    Guri-si, Gyeonggi-do, 11923, South Korea

  • Novartis Investigative Site

    Jinju, Gyeongsangnam-do, 52727, South Korea

  • Novartis Investigative Site

    Jeonju, Jeollabuk-do, 54907, South Korea

  • Novartis Investigative Site

    Iksan Si, Jeonlabuk Do, 54538, South Korea

  • Novartis Investigative Site

    Daejeon, Korea, 35015, South Korea

  • Novartis Investigative Site

    Busan, 48108, South Korea

  • Novartis Investigative Site

    Gyeongsangnam Do, 51353, South Korea

  • Novartis Investigative Site

    Jeju City, 63241, South Korea

  • Novartis Investigative Site

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Seoul, 06273, South Korea

  • Novartis Investigative Site

    Seoul, 137 707, South Korea

  • Novartis Investigative Site

    Taegu, 41944, South Korea

  • Novartis Investigative Site

    Ulsan, 44033, South Korea

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