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

Open label study comparing the efficacy of Tacrolimus and tadalafil versus oral Mycophenolate in patients of systemic sclerosis with ILD

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/05/013619

Enrollment

Registered

2018-05-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Interstitial lung disease of Scleroderma Health Condition 2: M340- Progressive systemic sclerosis

Interventions

Control Intervention1: Mycophenolate Mofetil: Mycophenolate mofetil 1 gm twice a day for 6 months

Eligibility

Inclusion criteria

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) & DLCO <= 70 % of predicted.

Exclusion criteria

Exclusion criteria: 1. Those who cannot perform PFT or 6 min walk test at baseline 2. FVC 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 5. Serum creatinine >=2.0 mg/dl 6. Obstructive lung disease (FEV1/FVC ratio 11 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.

Design outcomes

Primary

Measure	Time frame
The primary outcome will be to assess the change in FVC (expressed as a percentage of the predicted value) from baseline values at the end of 6 months of treatment with Tacrolimus with Tadalafil in comparison to oral mycophenolate group. Secondary outcome measures will be improvement in dyspnea (as measured by Mahler dyspnoea index), 6 min walk distance, change in DLCO and total lung capacity (TLC) from baseline values, change in SHAQ ,SF-36, mRSS at the end of 6 month study period.Timepoint: The primary outcome will be to assess the change in FVC (expressed as a percentage of the predicted value) from baseline values at the end of 6 months of treatment with Tacrolimus with Tadalafil in comparison to oral mycophenolate group. Secondary outcome measures will be improvement in dyspnea (as measured by Mahler dyspnoea index), 6 min walk distance, change in DLCO and total lung capacity (TLC) from baseline values, change in SHAQ ,SF-36, mRSS at the end of 6 month study period.	—

Measure

Time frame

The primary outcome will be to assess the change in FVC (expressed as a percentage of the predicted value) from baseline values at the end of 6 months of treatment with Tacrolimus with Tadalafil in comparison to oral mycophenolate group. Secondary outcome measures will be improvement in dyspnea (as measured by Mahler dyspnoea index), 6 min walk distance, change in DLCO and total lung capacity (TLC) from baseline values, change in SHAQ ,SF-36, mRSS at the end of 6 month study period.Timepoint: The primary outcome will be to assess the change in FVC (expressed as a percentage of the predicted value) from baseline values at the end of 6 months of treatment with Tacrolimus with Tadalafil in comparison to oral mycophenolate group. Secondary outcome measures will be improvement in dyspnea (as measured by Mahler dyspnoea index), 6 min walk distance, change in DLCO and total lung capacity (TLC) from baseline values, change in SHAQ ,SF-36, mRSS at the end of 6 month study period.

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Secondary

Measure	Time frame
Secondary outcome measures will be improvement in dyspnea (as measured by Mahler dyspnoea index), 6 min walk distance, change in DLCO and total lung capacity (TLC) from baseline values, change in SHAQ ,SF-36, mRSS at the end of 6 month study period.Timepoint: 0, 6 months;Secondary outcome measures will be improvement in dyspnea (as measured by Mahler dyspnoea index), 6 min walk distance, change in DLCO and total lung capacity (TLC) from baseline values, change in SHAQ ,SF-36, mRSS at the end of 6 month study period.Timepoint: 0, 6 months	—

Measure

Time frame

Secondary outcome measures will be improvement in dyspnea (as measured by Mahler dyspnoea index), 6 min walk distance, change in DLCO and total lung capacity (TLC) from baseline values, change in SHAQ ,SF-36, mRSS at the end of 6 month study period.Timepoint: 0, 6 months;Secondary outcome measures will be improvement in dyspnea (as measured by Mahler dyspnoea index), 6 min walk distance, change in DLCO and total lung capacity (TLC) from baseline values, change in SHAQ ,SF-36, mRSS at the end of 6 month study period.Timepoint: 0, 6 months

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Countries

India

Contacts

Public ContactVikas Agarwal

Dept of Clinical Immunology, SGPGIMS, Lucknow

vikasagr@yahoo.com8004904390

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026