High dose Rosuvastatin as an adjunctive treatment in acute exacerbation of chronic obstructive pulmonary disease

High dose Rosuvastatin as an adjunctive treatment in acute exacerbation of chronic obstructive pulmonary disease, a randomized double blind clinical trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016121020024N4

Enrollment

Registered

2017-02-10

Start date

2017-01-30

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease with acute exacerbation. Chronic obstructive pulmonary disease with acute exacerbation, unspecified

Interventions

Intervention 1: The drug group will receive Rosuvastain tablet (Ropixon ®), dose 40 mg, manufactured by Dr. ABIDI PHARMACEUTICAL LABORATORY. The patients will receive the drug, once daily (first dose

Treatment - Drugs

Placebo

The drug group will receive Rosuvastain tablet (Ropixon ®), dose 40 mg, manufactured by Dr. ABIDI PHARMACEUTICAL LABORATORY. The patients will receive the drug, once daily (first dose on the first day

The placebo group will receive a tablet with exact shape of Rosuvastain tablet provided by Dr. ABIDI PHARMACEUTICAL LABORATORY. The patients will receive the placebo, once daily (first dose on the fi

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: - Inclusion criteria: 1) hospitalized patients with acute exacerbation of COPD (AECOPD) according to 2 of following symptoms: Dyspnea, increased sputum and/or purulent sputum; 2) Age > 40; 3)Previous Spirometry or clinical history compatible with COPD. - Exclusion criteria: 1) Acute coronary syndrome; 2) history of statin therapy; 3)endotracheal intubation; 4) significant associated comorbidities (cardiac, renal or hepatic); 5) history of musculoskeletal disorders; 6) history of intolerance to statins.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
In hospital mortality. Timepoint: ?during hospitalization. Method of measurement: monitoring of the patients' clinical status.;Duration of hospitalization. Timepoint: during patients' hospital stay. Method of measurement: time period of hospitalization in days.;Recurrencof acute COPD exacerbation. Timepoint: Within 3 months after taking meication. Method of measurement: Telephone follow-up.	—

Secondary

Measure	Time frame
COPD Assessment Test (CAT) questionnaire, persian version. Timepoint: in 1st and 3rd day after initiation of medication. Method of measurement: COPD Assessment Test (CAT) questionnaire score.;Arterial oxygen saturation of hemoglobin. Timepoint: in 1st and 3rd day of taking medication. Method of measurement: Pulse oximeter - Beurer GmbH.;Arterial PCO2. Timepoint: in 1st and 3rd day of taking medication. Method of measurement: VL 995 blood gas analyzer.	—

Measure

Time frame

COPD Assessment Test (CAT) questionnaire, persian version. Timepoint: in 1st and 3rd day after initiation of medication. Method of measurement: COPD Assessment Test (CAT) questionnaire score.;Arterial oxygen saturation of hemoglobin. Timepoint: in 1st and 3rd day of taking medication. Method of measurement: Pulse oximeter - Beurer GmbH.;Arterial PCO2. Timepoint: in 1st and 3rd day of taking medication. Method of measurement: VL 995 blood gas analyzer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Soheil Peiman

Department of Internal medicine, Tehran University of Medical Sciences

s-peiman@tums.ac.ir+98 21 6693 9922

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026