Effect of Inhaled indacaterol/glycopyrronium/mometasone furoate fixed-dose triple formulation on pulmonary function, symptoms and inflammation control in patients with asthma complicated with COPD

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300079273

Enrollment

Unknown

Registered

2023-12-29

Start date

2024-01-01

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asthma-COPD overlap

Interventions

Test Group A:Inhaled indacaterol/glycopyrronium/mometasone furoate fixed-dose (160/150/50µg,qd)

Control group B:Budesonide formoterol inhalation powder aerosol (160/4.5 micrograms, 2 inhalations per bid) plus tiotropium bromide inhaler (2.5 micrograms, once a day, 2 inhalations per inhalation)

Control group C:Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol (160/4.8/7.2µg,bid,2 inhalations per inhalation)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: A. Patient is over 18 years old; B. Patients with a diagnosed COPD who have reversible airflow limitation (improvement in FEV1 >12% with an absolute increase of >200 ml after bronchodilator inhalation), elevated FeNO (>22.5 ppb) and/or induced sputum eosinophilia, and a previous history of asthma; or patients with diagnosed asthma, after 3~6 months of standardized treatment, still have persistent airflow limitation (FEV1/FVC <70% after inhalation of bronchodilators), a history of exposure to harmful gases or substances (smoking or previous smoking = 10 pack-years), high-resolution CT (HRCT) to determine the presence of emphysema and decreased diffusion function of pulmonary function tests. C. Patient signs informed consent;

Exclusion criteria

Exclusion criteria: A. Patients with hypersensitivity to study drug components are excluded; B. Patients with acute exacerbations within 1 month are excluded from unstable condition; C. Pregnant and lactating females; D. Those with a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, and poor compliance; E. Participation in other clinical trials within 4 weeks or other conditions deemed by the investigator to be inappropriate to participate in this study

Design outcomes

Secondary

Measure	Time frame
Lung function trough FEV1 trough improvement from baseline;Change from baseline in ACT score;Inflammatory biomarkers (FENO, etc.);Inhaled medication adherence (TAI test and MMAS-8 score);Time of asthma exacerbation;Related concomitant medications;	—

Countries

China

Contacts

Public ContactZhuo Cao

Lishui People's Hospital

caozhuo1017@126.com+86 189 5709 1310

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026