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New treatment option for Asthma, COPD
Official title Effect of Spacer Use on Exacerbation Risk in High-Risk Older Adults With Chronic Airway Diseases Receiving Triple Therapy
ClinicalTrials.gov ID: NCT07030881
What this study is testing
What is pMDI Triple Inhaler Only?
pMDI Triple Inhaler Only is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for asthma, copd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study evaluates whether adding a spacer device to triple inhaled therapy (ICS/LABA/LAMA via pMDI) can reduce acute exacerbations in elderly patients (≥65 years) with stable chronic airway diseases (COPD or asthma) who are classified as high-risk based on GOLD or GINA guidelines. High risk is defined as ≥1 hospitalization or ≥2 moderate exacerbations in the past 12 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Age ≥65 years, no gender restriction;
- Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD criteria or bronchial asthma based on GINA criteria;
- Currently on stable treatment with fixed-dose combination ICS/LABA/LAMA via pMDI for ≥4 weeks;
- History of any of the following in the past 12 months:
- ≥1 hospitalization due to exacerbation, or
You likely can't join if
- Use of other inhalation devices as primary therapy (e.g., DPI, SMI, or nebulizer);
- Regular use of a spacer device for ≥3 weeks within 3 months prior to enrollment;
- Current or recent (within 4 weeks) acute exacerbation not fully resolved;
- Severe cognitive impairment (MMSE score \<18);
- Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure);
- Participation in another treatment clinical trial;
See the full eligibility criteria
- Age ≥65 years, no gender restriction;
- Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on GOLD criteria or bronchial asthma based on GINA criteria;
- Currently on stable treatment with fixed-dose combination ICS/LABA/LAMA via pMDI for ≥4 weeks;
- History of any of the following in the past 12 months:
- ≥1 hospitalization due to exacerbation, or
- ≥2 moderate exacerbations requiring systemic corticosteroids and/or antibiotics;
- Able to complete inhalation technique training and demonstrate basic communication and device-handling abilities;
- Provides written informed consent to participate in the study.
- Use of other inhalation devices as primary therapy (e.g., DPI, SMI, or nebulizer);
- Regular use of a spacer device for ≥3 weeks within 3 months prior to enrollment;
- Current or recent (within 4 weeks) acute exacerbation not fully resolved;
- Severe cognitive impairment (MMSE score \<18);
- Presence of severe systemic comorbidities (e.g., end-stage malignancy, advanced heart failure, hepatic or renal failure);
- Participation in another treatment clinical trial;
- Inability to use a mouthpiece-based spacer (e.g., structural oral/facial abnormalities, severe anxiety);
- Known allergy or hypersensitivity to spacer device materials.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Harbin, China
- Hefei, China
- Ningbo, China
- Ninghai, China
- Taizhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Harbin, China; Hefei, China; Ningbo, China; Ninghai, China; Taizhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.