Atorvastatin to Treat Pulmonary Sarcoidosis

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ClinicalTrials.gov Identifier: NCT00279708

Recruitment Status : Completed

First Posted : January 19, 2006

Results First Posted : August 12, 2016

Last Update Posted : May 22, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Joseph R. Fontana, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Sarcoidosis, Pulmonary
Interventions	Drug: Atorvastatin Other: Placebo Oral Tablet
Enrollment	55

Participant Flow

Recruitment Details	Subjects were recruited by national advertising (self-referrals), physician referrals, and through a medical clinic sponsored by the NIH, from March 2006 through March 2015.
Pre-assignment Details	Subjects were screened by telephone and later during clinical testing a evaluation at the NIH Clinical Center. During this time subjects were evaluated to determine if they met the enrollment criteria, including that of treatment requiring disease, and relatively stable dosing prior to entry.


Arm/Group Title	Intervention Group (Atorvastatin)	Control Group (Placebo)
Arm/Group Description	Atorvastatin Subjects were assigned...	Placebo In a double-blind fashion, ...
Arm/Group Description	Atorvastatin Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.	Placebo In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
Period Title: Overall Study
Started	27 ^[1]	28
Completed	24	24
Not Completed	3	4
Reason Not Completed
Withdrawal by Subject	2	3
Adverse Event	1	1
[1] "Started" meaning randomized

Baseline Characteristics

Arm/Group Title		Intervention Group (Atorvastatin)	Control Group (Placebo)	Total
Arm/Group Description		Atorvastatin: Subjects were assigne...	Placebo: In a double-blind fashion,...	Total of all reporting groups
Arm/Group Description		Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.	Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.	Total of all reporting groups
Overall Number of Baseline Participants		27	28	55
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	27 participants	28 participants	55 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	26 96.3%	28 100.0%	54 98.2%
	>=65 years	1 3.7%	0 0.0%	1 1.8%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	27 participants	28 participants	55 participants
		48.9 (7.95)	46.8 (9.12)	47.8 (8.57)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	27 participants	28 participants	55 participants
	Female	17 63.0%	16 57.1%	33 60.0%
	Male	10 37.0%	12 42.9%	22 40.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	27 participants	28 participants	55 participants
United States		27	28	55

Outcome Measures

1.Primary Outcome


Title	The Steroid Sparing Period
Description	The duration of steroid sparing was defined as the date when the targe...
Description	The duration of steroid sparing was defined as the date when the target dose of prednisone was reached until the date at which the dose was increased and/or met the relapse (flare) criteria; or until the 12 month study phase ended if no prednisone dose increase was required. The steroid sparing period was measured in units of days. The prednisone target dose was defined as a 90% reduction of the baseline dose or an absolute prednisone dose of 4 mg/day or less.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Intervention Group (Atorvastatin)	Control Group (Placebo)
Arm/Group Description:	Atorvastatin: Subjects were assigne...	Placebo: In a double-blind fashion,...
Arm/Group Description:	Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.	Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study: Placebo vs. Atorvastatin
Overall Number of Participants Analyzed	27	28
Mean (Inter-Quartile Range) Unit of Measure: days
	301 (2 to 315)	257 (152 to 322)

2.Secondary Outcome


Title	Pulmonary Sarcoidosis Flares
Description	Flare rates and relative risk: Flares (relapses) were defined as the p...
Description	Flare rates and relative risk: Flares (relapses) were defined as the physiological deterioration in pulmonary function due to worsened pulmonary inflammation. The criteria used for a pulmonary flare included: > 15% decline in static function (FEV1 post, FVC post); or (> 20% DLCO adj); or a > 15% decline in walk distance as measured by the six minute walk test, or via a decline in oxygen consumption collected during a cardiopulmonary exercise test (CPET). Additional factors considered included an increase in dyspnea (>15% increase in the dyspnea scale (TDI); and/or significant radiographic worsening. Clinical assessment of the patient's status may have been factored into the criteria for flare determination as well.
Time Frame	1 year