Trials / Unknown
UnknownNCT03563001
Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Zhujiang Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to research the differences of small airways function between subjects with diagnosis of chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).The assessment of quality of life is also carried out through questionnaires.
Detailed description
This is a randomized,open-label study to research the differences of small airways function between simple chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).Assessment of small airways is conducted at baseline,including forced expired volume in one second(FEV1),forced vital capacity(FVC),peak expiratory flow(PEF),maximum expiratory flow rate at 75% of vital capacity(MEF75),maximum expiratory flow rate at 50% of vital capacity(MEF50),maximum expiratory flow rate at 25% of vital capacity(MEF25),impulse oscillometry,diffusion function,residual volume(RV) and total lung capacity(TLC).Budesonide(160ug) and formoterol(4.5ug) bid will be given to both groups(chronic obstructive pulmonary disease and asthma-COPD overlap) for 3 months.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ) and chronic obstructive pulmonary disease assessment test(CAT).All of the patients will have a follow-up visit after 3 months' treatment.
Conditions
- Pulmonary Disease, Chronic Obstructive
- Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
- Small Airway Disease
- Quality of Life
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Budesonide(160ug) and Formoterol(4.5ug) bid | For both groups of subjects,small airways function of is assessed at baseline.And then budesonide(160ug) and formoterol(4.5ug) bid will be given to the subjects for 3 months.The subjects will have a follow-up visit with the same examinations after 3 months' treatment. |
Timeline
- Start date
- 2018-06-20
- Primary completion
- 2018-09-01
- Completion
- 2018-09-01
- First posted
- 2018-06-20
- Last updated
- 2018-06-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03563001. Inclusion in this directory is not an endorsement.