Evaluation of the effectiveness of medroxyprogesterone on blood gases and short term hospital outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD) exacerbation who received Non Invasive Ventilation (NIV)

Evaluation of the effectiveness of Medroxyprogesteron compared to placebo on blood gases and short term hospital outcomes (dyspnea, hospitalization days, ICU admission, intubation, O2 saturation and NIV hours/day usage) in patients with Chronic Obstructive Pulmonary Disease (COPD) exacerbation who received Non Invasive Ventilation (NIV)

Two arm parallel group randomised trial, double blinded, phase3, design of 75 patients, randomised base on permuted block randomization

This study is done in Al-Zahra and Khorshid hospital at Isfahan, Chronic Obstructive Pulmonary Disease (COPD) exacerbation patients who are randomisation with Random Allocation software.Intervention group recieve medroxy progesteron and control group recieve placebo. Both groups also recieve standard cares and Non Invasive Ventilation (NIV)

Inclusion criteria:Chronic Obstructive Pulmonary Disease (COPD) exacerbation patients who has one of this criteria (dyspnea, increased sputum volume, and a change in the nature of sputum) COPD exacerbation patient who needs Non Invasive Ventilation (NIV) Age between 30-80 Exclusion criteria: Requiring mechanical ventilation by the time of admission Having a current or history of thromboembolic diseases History of cerebrovascular disease, history of myocardial infarction (MI) and stroke Unexplained vaginal bleeding History of breast cancer, or any estrogen- or progesterone-dependent tumor Decreased level of consciousness Deformity or trauma in face

Intervention group received tablets of progesterone 15 mg, every 6 hours for 5 days and control received placebo tablets with similar shape to progesterone tablets.

Atrial Blood Gases(ABG), hospital short outcome (dyspnea,hospitalization days,ICU admission,intubation,O2 saturation ,NIV hours/day usage)

Patients were recruited based on the mentioned criteria and 70 patients are selected.They are randomly divided into two groups based on permuted block randomization by using Random Allocation software that each group(case and control)contain of 35 participant.For assurance of participant are divided equally to case and control in consecutive interval,we use 10 blocked randomization that each of them contain 7 participant.Odd blocks are interventional group and even blocks are control group.

In this study participants and doctors are blind.participant after signing informed consent,accept that may recieve drug or placebo.Doctors dont know which patient may recieve medroxy progesteron or placebo.Doctors after initial visit of COPD exacerbation patients who need Non Invasive Ventilation(NIV),report the patients to study supervisior(pulmonary fellowship).Study supervisior is checking inclusion and exclusion criteria and recieved informed consent.After randomazation by study supervisor ,drugs or placebo are taken to nurse of patients (who are blind)for daily prescription.Also nurse dont know that the patient recieve placebo or drug.Study forms are completed by doctors daily.After 5th days,supervisior collect forms and drug or placebo prescription discontinue.

We decide to share our questionare forms (after unidentifiable) and SPSS files of primary and secondary variables and data analysis of our study by other researchers

6 month after article is published

Reshearcher in medical and pharmaceutical field that work in university or pharmacy company

After we study their study proposal,usage of our data will be possible.Analysis of ourdata according to their study will be possible.if usage our data help them to result in an article,we expect our name mention as colleague

Email to me minanickpour@yahoo.com

First we must study their research proposal,if our data help them,immediately we give our datas and SPSS files and other files if needed