Atorvastatin to Treat Pulmonary Sarcoidosis

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

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Intervention Group (Atorvastatin)	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.
Control Group (Placebo)	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.

Participant Flow:   Overall Study

	Intervention Group (Atorvastatin)	Control Group (Placebo)
STARTED	27 [1]	28
COMPLETED	24	24
NOT COMPLETED	3	4
Withdrawal by Subject	2	3
Adverse Event	1	1

[1]	"Started" meaning randomized

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Intervention Group (Atorvastatin)	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.
Control Group (Placebo)	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	Total of all reporting groups

Baseline Measures

	Intervention Group (Atorvastatin)	Control Group (Placebo)	Total
Overall Participants Analyzed; [Units: Participants]	27	28	55
Age; [Units: Participants]; Count of 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; [Units: Years]; Mean (Standard Deviation)	48.9 (7.95)	46.8 (9.12)	47.8 (8.57)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	17 63.0%	16 57.1%	33 60.0%
Male	10 37.0%	12 42.9%	22 40.0%
Region of Enrollment; [Units: Participants]
United States	27	28	55

  Outcome Measures

1. Primary:

The Steroid Sparing Period [ Time Frame: 1 year ]

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2. Secondary:

Pulmonary Sarcoidosis Flares [ Time Frame: 1 year ]

Results not yet reported.   Anticipated Reporting Date:   09/2017  

3. Secondary:

Pulmonary Function Tests [ Time Frame: 12 month treatment period ]

Results not yet reported.   Anticipated Reporting Date:   09/2017  

4. Secondary:

Exercise Performance [ Time Frame: 12 month treatment period ]

Results not yet reported.   Anticipated Reporting Date:   09/2017  

5. Secondary:

Quality of Life and Dyspnea Scales [ Time Frame: 12 month treatment period ]

Results not yet reported.   Anticipated Reporting Date:   09/2017  

6. Other Pre-specified:

Chest Imaging [ Time Frame: 12 month treatment period ]

Results not yet reported.   Anticipated Reporting Date:   09/2018  

  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The recruitment goal of 96 subjects was not met due to slow accrual. The primary endpoint analysis was based on the available subject data.

  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Joseph Fontana, MD
Organization: The National Institutes of Health/ The National Heart, Lung, and Blood Institute
phone: 301-451-7740
e-mail: fontanaj@nhlbi.nih.gov

Publications:

Statement on sarcoidosis. Joint Statement of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) adopted by the ATS Board of Directors and by the ERS Executive Committee, February 1999. Am J Respir Crit Care Med. 1999 Aug;160(2):736-55. Review.

Newman LS, Rose CS, Maier LA. Sarcoidosis. N Engl J Med. 1997 Apr 24;336(17):1224-34. Review. Erratum in: N Engl J Med 1997 Jul 10;337(2):139.

Thomas KW, Hunninghake GW. Sarcoidosis. JAMA. 2003 Jun 25;289(24):3300-3. Review.

Responsible Party:	Joseph R. Fontana, M.D., National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00279708 History of Changes
Other Study ID Numbers:	060072; 06-H-0072 ( Other Identifier: NIH NHLBI )
First Submitted:	January 18, 2006
First Posted:	January 19, 2006
Results First Submitted:	June 30, 2016
Results First Posted:	August 12, 2016
Last Update Posted:	May 22, 2017