NCT05786950

Brief Summary

To investigate the relationship among the neural respiratory drive (NRD), the sensation of the dyspnea and the effect of the bronchodilator on each stage COPD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 7, 2025

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 4, 2023

Last Update Submit

May 4, 2025

Conditions

Keywords

neural respiratory drivechronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (1)

  • the change of the neural respiratory drive

    the change of the neural respiratory drive

    20 minutes

Secondary Outcomes (1)

  • comfort sensation

    20 minutes

Study Arms (1)

bronchodilators

EXPERIMENTAL

compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)

Drug: compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)

Interventions

inhaled compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany)

bronchodilators

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The diagnosis of COPD was made according to the global initiative for chronic obstructive lung disease (GOLD) guideline.

You may not qualify if:

  • (1) Malignancy (2)Severe cardiovascular diseases (3)Neuromuscular and chest wall deformity (4) Cardiovascular instability (hypotension, arrhythmias, myocardial infarction) (5) Change in mental status; uncooperative patients (6) Extreme obesity (7)renal failure and severe blood electrolyte disturbances (8) Asthma-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1State Key Laboratory of Respiratory Disease, National clinical research center for respiratory disease, Guangzhou Institute of respiratory health. 2The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 520120, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

AlbuterolIpratropium

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesAtropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • jianheng zhang, MD

    State Key Laboratory of Respiratory Disease

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: the responds of the neural respiratory drive of the chronic obstructive pulmonary disease patients after inhaling bronchodilator(3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2023

First Posted

March 28, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

September 1, 2024

Last Updated

May 7, 2025

Record last verified: 2023-03

Locations