PIFR-based Inhalation Therapy in Patients Recovering From AECOPD

NCT04000958 | Unknown

• 1 other identifier: B2019-142
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine whether the optimized inhalation therapy based on peak inspiratory flow rates (PIFR) measured against the simulated resistance can reduce the rate of treatment failure in patients recovering from acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Errors in inhaler use and quality of life are also to be evaluated. The study will recruit 460 patients with AECOPD whose exacerbated symptoms are relieved by 5-7 days of standard therapy. The participants are divided into PIFR group and control group in a 1:1 ratio according to a random number table method. All the patients will be given inhaled corticosteroid（ICS）/long-acting β agonist（LABA） (budesonide/ formoterolSymbicort turbuhaler® 160/4.5 μg bid or Beclometasone/ Formoterol Foster® pressure metered dose inhaler(pMDI) 100/6 μg 2 puff bid). For symptomatic patients before acute exacerbation, Spiriva handihaler® 18μg qd or Spiriva respimat® 2.5μg qd will be prescribed in combination with ICS/LABA. For PIFR group, PIFR is measured by InCheck DIAL(Clement Clarke International Ltd, Harlow, UK and Alliance Tech Medical). If PIFR is less than 60L/min , the patient will be given pMDI with spacer. If PIFR value is over 60 L/min, the patient will be given dry powder inhaler(DPI).). The control group will be given DPI or pMDI with spacer according to the judgment of a respiratory physician. Both groups will be taught to use the device after the prescription, and then be reminded to use medication via a WeChat public account. The primary endpoint of the study is the 30-day treatment failure including AECOPD recurrence resulting in an emergency visit, admission, or need for intensified medication). The secondary endpoints of the study are the error rate of inhalation device use, satisfaction with inhalation devices, symptoms and quality of life, 30-day mortality, chronic obstructive pulmonary diseases(COPD)-related treatment costs and PIFR.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 30-day treatment failure rate

  Treatment failure means AECOPD recurrence resulting in an emergency visit, admission, or need for intensfied medication.

  30 days

Secondary Outcomes (9)

• the error rate of inhalation device use

  30 days/ 90 days

• satisfaction with inhalation devices

  30 days/ 90 days

• score of St.George's Respiratory Questionnaire(SGRQ)

  30 days/ 90 days

• 30-day mortality

  30 days

• COPD-related treatment costs

  30 days/ 90 days

Study Arms (2)

PIFR group

EXPERIMENTAL

Drug: PIRF measured by InCheck DIAL

control group

ACTIVE COMPARATOR

Drug: Regular treament

Interventions

PIRF measured by InCheck DIAL DRUG

Peak inspiratory flow rates(PIFR) will be measured using the InCheck DIAL(Clement Clarke International Ltd, Harlow, UK and Alliance Tech Medical). The InCheck DIAL is accurate to +/- 10% or 10 L/min, whichever is greater, and can measure flows in the range of 15 to 120 L/min. Dry powder inhaler(DPI) is to be prescribed if PIFRr is over 60L/min, otherwise pressure metered dose inhaler(pMDI) with spacer is given. All the patients will be given inhaled corticosteroid（ICS）/long-acting β agonist（LABA）. For symptomatic patients, long-acting anticholinergic agents(LAMA) will also be used.

PIFR group

Regular treament DRUG

The choice of inhalers depends on physician's evaluation. The medication is the same as experimental group.

control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute exacerbation of chronic obstructive pulmonary disease(AECOPD) whose acute respiratory symptoms have been controlled after 5-7 day-standard AECOPD treatment including atomized or inhaled brochodilator plus oral or intravenous glucocorticoid (prednisone equivalent dose 40-50mg) or Pulmicort 2mg atomization Bid plus broad-spectrum antibiotics.
• Patients with moderate and above chronic obstructive pulmonary disease diagnosed by spirometry, ie, forced expiratory volume in one second(FEV1)/forced vital capacity(FVC) \<70% post-bronchodilator and FEV1% predicted value \<80%.
• Patients have signed an informed consent form.

You may not qualify if:

• Patients who is already using home nebulization therapy because of the severity of the illness.
• Patients with bronchial asthma, pulmonary interstitial fibrosis, bronchiectasis, pulmonary embolism and other lung diseases; or hypertension, heart disease, chronic liver and kidney disease, diabetes, chronic gastrointestinal diseases, malignant tumors, critically ill patients.
• Patient's mental state cannot match the observation or suffer from cognitive impairment.
• Patient's peak inspiratory flow rates (PIFR) is less than 20L/min.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

Related Publications (1)

• Hua J, Zhang W, Cao HF, Du CL, Ma JY, Zuo YH, Zhang J. Effect of PIFR-based optimised inhalation therapy in patients recovering from acute exacerbation of chronic obstructive pulmonary disease: protocol of a prospective, multicentre, superiority, randomised controlled trial. BMJ Open. 2020 May 7;10(5):e034804. doi: 10.1136/bmjopen-2019-034804.

  PMID: 32385061 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jing Zhang, MD

CONTACT

+86 18616881189; zhang.jing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 27, 2019
• Study Start: September 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)