Tadalafil plus tacrolimus vs Mycophenolate mofetil in treatment of interstitial lung disease of scleroderma

Phase 3

• Conditions: Health Condition 1: null- Interstitial lung disease of SclerodermaHealth Condition 2: M340- Progressive systemic sclerosis

• Registration Number: CTRI/2018/05/013619
• Lead Sponsor: Self

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

42 Patients with systemic sclerosis (fulfilling 2013 ACR/EULAR classification

criteria) between age of 18 to 60 years.

1. Having evidence of ILD in HRCT

2. Pulmonary function test (PFT) showing Forced Vital Capacity (FVC)<= 80% predicted

& DLCO <= 70 % of predicted.

Exclusion Criteria

1. Those who cannot perform PFT or 6 min walk test at baseline

2. FVC <45% of predicted or DLCO (Hg-corrected) <40% of predicted.

3. Taken high dose prednisolone (1 mg/kg) or cyclophosphamide ( >500 mg) or MMF ( >

500mg/d) or azathioprine ( >1 mg/kg) for more than 4 weeks anytime within previous

6 months.

4. SBP < 90 mmHg or history of orthostatic hypotension

5. Serum creatinine >=2.0 mg/dl

6. Obstructive lung disease (FEV1/FVC ratio < 0.6),

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7. Received prostacyclins or endothelin antagonists or any investigational drug within

the prior month.

8. History of acute coronary or cerebrovascular event within 3 months

9. Evidence of malignancy, peptic ulcer, renal or hepatic dysfunction.

10. Prednisolone (for indications other than ILD) will be allowed up to 10 mg/d in all

patients.

11. All the married women of reproductive age group will undergone pregnancy testing

and will be advised non-hormonal contraception during the study period.

Study & Design

• Study Type: Observational
• Study Design: Not specified