Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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.
n/a
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