PIFR-based Inhalation Therapy in Patients Recovering From AECOPD

Optimized Inhalation Therapy Based on Peak Inspiratory Flow Rates Measured Against the Simulated Resistance in Patients Recovering From Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Randomized Trial (PIFR-OIT Study)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: PIRF measured by InCheck DIAL; Drug: Regular treament

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Drug: Regular treament; The choice of inhalers depends on physician's evaluation. The medication is the same as experimental group.
Experimental: PIFR group	Drug: PIRF measured by InCheck DIAL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day treatment failure rate	Treatment failure means AECOPD recurrence resulting in an emergency visit, admission, or need for intensfied medication.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day mortality		30 days
90-day mortality		90 days
the error rate of inhalation device use		30 days/ 90 days
satisfaction with inhalation devices	Patients' satisfaction with inhalation devices will be assessed by the following items. If the patient meets any of the following, the result will be unsatisfactory: The patient has forgotten to use the inhaler.; The patient has forgotten to use the inhaler in the last two weeks.; The patient has reduced the frequency of using inhaler without medical advice.; The patient has forgotten to bring an inhaler when traveling or leaving home.; The patient has quitted the inhaler without medical advice when feeling his condition improved.; The patient has felt it difficult to comply with the COPD treatment plan.; The patient has felt it difficult to use the inhaler.	30 days/ 90 days
score of St.George's Respiratory Questionnaire(SGRQ)	St.George's Respiratory Questionnaire(SGRQ) is used to assess patient's quality of life. The SGRQ scale range is from 0 to 100. The higher the score is, the more severe the impact of COPD on patient' life is.	30 days/ 90 days
COPD-related treatment costs		30 days/ 90 days
Peak Inspiratory Flow Rates（PIFR）		30 days/ 90 days
score of modified British medical research council(mMRC)	Modified British medical research council(mMRC) is used to assess patient's symptoms. The mMRC scale range is from 0 to 4. The higher the score is, the more severe the patient's dyspnea is.	30 days/ 90 days
score of COPD assessment test(CAT)	COPD assessment test(CAT) is used to assess patient's symptoms. The CAT scale range is from 0 to 40. A score of 0-10 indicates the patient is slightly affected by COPD. A score of 11-20 indicates the patient is moderately affected by COPD. A score of 21-30 indicates the patient is seriously affected by COPD. A score of 31-40 indicates the patient is extremely affected by COPD.	30 days/ 90 days

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• 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. Erratum In: BMJ Open. 2020 Aug 20;10(8):e034804corr1.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: B2019-142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No