Trial Outcomes & Findings for Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease (NCT NCT00929734)

Last Updated: 2015-10-08

Results Overview

Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

99 participants

Primary outcome timeframe

Baseline to 3 months

Results posted on

2015-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Rosuvastatin Rosuvastatin: 10mg tablets, once daily in three months	Placebo Placebo: 1 tablet, once daily in three months
Overall Study STARTED	49	50
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Rosuvastatin Rosuvastatin: 10mg tablets, once daily in three months	Placebo Placebo: 1 tablet, once daily in three months
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rosuvastatin n=47 Participants Rosuvastatin 10mg tablet	Placebo n=47 Participants Placebo tablet	Total n=94 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 5.5 • n=5 Participants	63 years STANDARD_DEVIATION 6.6 • n=7 Participants	65 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
BMI	23 kg/m^2 STANDARD_DEVIATION 3.8 • n=5 Participants	24 kg/m^2 STANDARD_DEVIATION 4.1 • n=7 Participants	24 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants
Systolic blood pressure	131 mmHg STANDARD_DEVIATION 17.7 • n=5 Participants	135 mmHg STANDARD_DEVIATION 20.1 • n=7 Participants	133 mmHg STANDARD_DEVIATION 18.9 • n=5 Participants
Diastolic blood pressure	79 mmHg STANDARD_DEVIATION 8.4 • n=5 Participants	80 mmHg STANDARD_DEVIATION 10.3 • n=7 Participants	80 mmHg STANDARD_DEVIATION 9.4 • n=5 Participants
Heart rate	68 beats/min STANDARD_DEVIATION 11.2 • n=5 Participants	67 beats/min STANDARD_DEVIATION 10.9 • n=7 Participants	67 beats/min STANDARD_DEVIATION 11.0 • n=5 Participants
History of hypertension Yes	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants
History of hypertension No	35 participants n=5 Participants	36 participants n=7 Participants	71 participants n=5 Participants
History of asthma Yes	9 participants n=5 Participants	13 participants n=7 Participants	22 participants n=5 Participants
History of asthma No	38 participants n=5 Participants	34 participants n=7 Participants	72 participants n=5 Participants
Pack-years	39 pack-years STANDARD_DEVIATION 16.1 • n=5 Participants	35 pack-years STANDARD_DEVIATION 15.5 • n=7 Participants	37 pack-years STANDARD_DEVIATION 15.8 • n=5 Participants
Current smoking Yes	12 participants n=5 Participants	23 participants n=7 Participants	35 participants n=5 Participants
Current smoking No	35 participants n=5 Participants	24 participants n=7 Participants	59 participants n=5 Participants
Haemoglobin	14.1 g/dl STANDARD_DEVIATION 1.4 • n=5 Participants	14.0 g/dl STANDARD_DEVIATION 0.2 • n=7 Participants	14.0 g/dl STANDARD_DEVIATION 1.2 • n=5 Participants
Estimated Glomerular Filtration Rate (eGFR)	82.4 ml/min STANDARD_DEVIATION 19.6 • n=5 Participants	90.1 ml/min STANDARD_DEVIATION 29.4 • n=7 Participants	86.2 ml/min STANDARD_DEVIATION 25.1 • n=5 Participants
Leucocyte count	6.6 cells*10^9/L STANDARD_DEVIATION 1.4 • n=5 Participants	6.9 cells*10^9/L STANDARD_DEVIATION 1.7 • n=7 Participants	6.7 cells*10^9/L STANDARD_DEVIATION 1.6 • n=5 Participants
High-sensitivity C-reactive protein	1.4 mg/L n=5 Participants	1.8 mg/L n=7 Participants	1.7 mg/L n=5 Participants
Interleukin 6	4.1 pg/mL n=5 Participants	3.4 pg/mL n=7 Participants	3.7 pg/mL n=5 Participants
Glucose	5.0 mmol/L STANDARD_DEVIATION 0.6 • n=5 Participants	5.1 mmol/L STANDARD_DEVIATION 0.7 • n=7 Participants	5.0 mmol/L STANDARD_DEVIATION 0.6 • n=5 Participants
Cholesterol	5.5 mmol/L STANDARD_DEVIATION 0.9 • n=5 Participants	5.7 mmol/L STANDARD_DEVIATION 1.1 • n=7 Participants	5.6 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants
LDL-C	3.3 mmol/L STANDARD_DEVIATION 0.8 • n=5 Participants	3.5 mmol/L STANDARD_DEVIATION 0.9 • n=7 Participants	3.4 mmol/L STANDARD_DEVIATION 0.9 • n=5 Participants
HDL-C	1.8 mmol/L STANDARD_DEVIATION 0.1 • n=5 Participants	1.8 mmol/L STANDARD_DEVIATION 0.1 • n=7 Participants	1.8 mmol/L STANDARD_DEVIATION 0.5 • n=5 Participants
Triglycerides	1.0 mmol/L STANDARD_DEVIATION 0.4 • n=5 Participants	1.1 mmol/L STANDARD_DEVIATION 0.5 • n=7 Participants	1.1 mmol/L STANDARD_DEVIATION 0.4 • n=5 Participants
Forced expiratory volume at one second (FEV1)	1.4 Liter STANDARD_DEVIATION 0.6 • n=5 Participants	1.5 Liter STANDARD_DEVIATION 0.7 • n=7 Participants	1.4 Liter STANDARD_DEVIATION 0.6 • n=5 Participants
FEV1, % of predicted	48.3 Percent predicted value STANDARD_DEVIATION 18.9 • n=5 Participants	52.1 Percent predicted value STANDARD_DEVIATION 18.8 • n=7 Participants	50.2 Percent predicted value STANDARD_DEVIATION 18.9 • n=5 Participants
FEV1/FVC	47 Percent of FVC STANDARD_DEVIATION 13.8 • n=5 Participants	49 Percent of FVC STANDARD_DEVIATION 11.8 • n=7 Participants	48 Percent of FVC STANDARD_DEVIATION 12.8 • n=5 Participants
Antihypertensive treatment Yes	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Antihypertensive treatment No	35 participants n=5 Participants	37 participants n=7 Participants	72 participants n=5 Participants
Inhaled corticosteroids Yes	36 participants n=5 Participants	34 participants n=7 Participants	70 participants n=5 Participants
Inhaled corticosteroids No	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
Long acting beta agonists Yes	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Long acting beta agonists No	45 participants n=5 Participants	44 participants n=7 Participants	89 participants n=5 Participants
Long acting muscarinic antagonists Yes	30 participants n=5 Participants	27 participants n=7 Participants	57 participants n=5 Participants
Long acting muscarinic antagonists No	17 participants n=5 Participants	20 participants n=7 Participants	37 participants n=5 Participants
Anti-inflammatory treatment Yes	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Anti-inflammatory treatment No	45 participants n=5 Participants	47 participants n=7 Participants	92 participants n=5 Participants
Oestrogen treatment Yes	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Oestrogen treatment No	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Complete case analysis

Outcome measures

Outcome measures
Measure	Rosuvastatin n=47 Participants Rosuvastatin: 10mg tablets, once daily in three months	Placebo n=47 Participants Placebo: 1 tablet, once daily in three months
Relative Change in Reactive Hyperemia Index (RHI)	6.65 percent change Interval 1.8 to 15.11	-1.27 percent change Interval -8.33 to 5.79

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Complete case analysis

Outcome measures

Outcome measures
Measure	Rosuvastatin n=47 Participants Rosuvastatin: 10mg tablets, once daily in three months	Placebo n=47 Participants Placebo: 1 tablet, once daily in three months
Relative Change in FEV1	2.6 percent change Interval -2.2 to 7.5	-1.1 percent change Interval -4.7 to 2.5

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Complete case analysis

Outcome measures

Outcome measures
Measure	Rosuvastatin n=47 Participants Rosuvastatin: 10mg tablets, once daily in three months	Placebo n=47 Participants Placebo: 1 tablet, once daily in three months
Relative Change in High-sensitivity C-reactive Protein	-20.0 percent change Interval -45.8 to 14.3	11.0 percent change Interval -35.1 to 93.3

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Complete case analysis

Outcome measures

Outcome measures
Measure	Rosuvastatin n=47 Participants Rosuvastatin: 10mg tablets, once daily in three months	Placebo n=47 Participants Placebo: 1 tablet, once daily in three months
Relative Change in Interleukin 6	8 percent change Interval -20.0 to 43.8	30 percent change Interval 0.0 to 52.2

Adverse Events

Rosuvastatin

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rosuvastatin n=47 participants at risk Rosuvastatin: 10mg tablets, once daily in three months	Placebo n=49 participants at risk Placebo: 1 tablet, once daily in three months
Respiratory, thoracic and mediastinal disorders Acute exacerbation of chronic obstructive pulmonary disease (AECOPD)	8.5% 4/47 • Number of events 4 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	4.1% 2/49 • Number of events 2 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Vascular disorders Hypophysis apoplexia	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	2.0% 1/49 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.

Other adverse events

Additional Information

Professor Torbjørn Omland

University of Oslo

Phone: +47 40107050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Rosuvastatin n=47 participants at risk Rosuvastatin: 10mg tablets, once daily in three months	Placebo n=49 participants at risk Placebo: 1 tablet, once daily in three months
Respiratory, thoracic and mediastinal disorders AECOPD	6.4% 3/47 • Number of events 3 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	24.5% 12/49 • Number of events 12 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Gastrointestinal disorders Constipation	2.1% 1/47 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	4.1% 2/49 • Number of events 2 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Gastrointestinal disorders Diarrhea	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	4.1% 2/49 • Number of events 2 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Gastrointestinal disorders Flatulence	2.1% 1/47 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	0.00% 0/49 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Nervous system disorders Nausea	4.3% 2/47 • Number of events 2 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	0.00% 0/49 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Gastrointestinal disorders Stomach pain	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	2.0% 1/49 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Musculoskeletal and connective tissue disorders Myalgia	2.1% 1/47 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	0.00% 0/49 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Nervous system disorders Orthostatic vertigo	2.1% 1/47 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	0.00% 0/49 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Nervous system disorders Migraine	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	2.0% 1/49 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Respiratory, thoracic and mediastinal disorders Sinusitis	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	2.0% 1/49 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Cardiac disorders Atrial fibrillation	2.1% 1/47 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	0.00% 0/49 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Musculoskeletal and connective tissue disorders Ankle edema	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	2.0% 1/49 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Vascular disorders Headache	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	2.0% 1/49 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Renal and urinary disorders Urinary retension	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	2.0% 1/49 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Psychiatric disorders Depression	0.00% 0/47 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	2.0% 1/49 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Respiratory, thoracic and mediastinal disorders Cold	2.1% 1/47 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	0.00% 0/49 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
Cardiac disorders Atrial flutter	2.1% 1/47 • Number of events 1 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.	0.00% 0/49 • 3 months Data are presented for all patients with adverse event registration (patient diary). The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data. 2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.