NCT00004563: SLS

Cyclophosphamide Versus Placebo in Scleroderma Lung Study

Completed Phase 3 Results posted Last updated 5 March 2015

What this trial tests

Phase 3 trial testing Cyclophosphamide in Lung Diseases in 158 participants. Completed in 1 May 2013.

Timeline

1 August 1999

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	158
Start date	1 August 1999
Primary completion	1 May 2013
Estimated completion	1 May 2013

Drugs / interventions tested

• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Placebo

Conditions studied

• Lung Diseases — all drugs for Lung Diseases →
• Pulmonary Fibrosis — all drugs for Pulmonary Fibrosis →
• Systemic Scleroderma — all drugs for Systemic Scleroderma →
• Scleroderma, Systemic — all drugs for Scleroderma, Systemic →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Lung Diseases or Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Forced Vital Capacity
  Time frame: 12 months
  The primary end point was the forced vital capacity (FVC, expressed as a percentage of the predicted value) at 12 months, after adjustment for the baseline FVC.

Sponsor's own description

To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and progression of symptomatic pulmonary disease in patients with systemic sclerosis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-resolution CT scan findings in patients with symptomatic scleroderma-related interstitial lung disease.
   Goldin JG, Lynch DA, Strollo DC, Suh RD, et al · · 2008 · cited 164× · PMID 18641099 · DOI 10.1378/chest.07-2444
2. Short-term progression of interstitial lung disease in systemic sclerosis predicts long-term survival in two independent clinical trial cohorts.
   Volkmann ER, Tashkin DP, Sim M, Li N, et al · · 2019 · cited 147× · PMID 30409830 · DOI 10.1136/annrheumdis-2018-213708
3. Etiology, Risk Factors, and Biomarkers in Systemic Sclerosis with Interstitial Lung Disease.
   Khanna D, Tashkin DP, Denton CP, Renzoni EA, et al · · 2020 · cited 140× · PMID 31841044 · DOI 10.1164/rccm.201903-0563ci
4. Progression of fibrosing interstitial lung disease.
   Wong AW, Ryerson CJ, Guler SA. · · 2020 · cited 122× · PMID 31996266 · DOI 10.1186/s12931-020-1296-3
5. Reliability and minimal clinically important differences of forced vital capacity: Results from the Scleroderma Lung Studies (SLS-I and SLS-II).
   Kafaja S, Clements PJ, Wilhalme H, Tseng CH, et al · · 2018 · cited 94× · PMID 29099620 · DOI 10.1164/rccm.201709-1845oc
6. Treatment of scleroderma-interstitial lung disease with cyclophosphamide is associated with less progressive fibrosis on serial thoracic high-resolution CT scan than placebo: findings from the scleroderma lung study.
   Goldin J, Elashoff R, Kim HJ, Yan X, et al · · 2009 · cited 89× · PMID 19892673 · DOI 10.1378/chest.09-0108
7. Predictors of lung function decline in scleroderma-related interstitial lung disease based on high-resolution computed tomography: implications for cohort enrichment in systemic sclerosis-associated interstitial lung disease trials.
   Khanna D, Nagaraja V, Tseng CH, Abtin F, et al · · 2015 · cited 82× · PMID 26704522 · DOI 10.1186/s13075-015-0872-2
8. Development of antifibrotic therapy for stricturing Crohn's disease: lessons from randomized trials in other fibrotic diseases.
   Lin SN, Mao R, Qian C, Bettenworth D, et al · · 2022 · cited 62× · PMID 34569264 · DOI 10.1152/physrev.00005.2021