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clinical trial of tadalafil effect on pulmonary function

Clinical trial of Tadalafil effect on DLCO. 6MWT, body plethysmography in scleroderma patients with paranchymal involvement, with and without pulmonary hypertension

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190202042598N1
Enrollment
70
Registered
2020-08-16
Start date
2018-12-22
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

interstitial lung disease in systemic sclerosis. Systemic sclerosis [scleroderma], 6MWT, interstitial lung diseases, body plethysmography, DLCO, Tadalafil,

Interventions

Intervention 1: Intervention group 1: Patients with sclerodermia and pulmonary hypertension: Individuals will receive 10 mg oral tadalafil (Adacirca) for the first two weeks and then 20 mg for 22weeks

Sponsors

Vice Chancellor of the National Research Institute of Tuberculosis and Lung Diseases
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: sclerodermic patients with parenchymal involvement and with pulmonary hypertension sclerodermic patients with parenchymal involvement and without pulmonary hypertension

Exclusion criteria

Exclusion criteria: others etiology of pulmonary hypertension use of other drugs of pulmonary hypertension use of nitrates and alpha receptor blockers Patient Satisfaction To Get Tadalafil

Design outcomes

Primary

MeasureTime frame
6 minutes walking test. Timepoint: before intervention, and 6 months after initiation of intervention. Method of measurement: puls oximeter divice.

Secondary

MeasureTime frame
Diffusion of lung carbon monoxide. Timepoint: before intervention and 6 months after initiation of intervention. Method of measurement: device of diffusion of lung carbon monoxide calculator.;Body plethysmography. Timepoint: before intervention, and 6 months after intervention. Method of measurement: device of body pletysmograpgy.;FEV1, FVC. FEV1/FVC. Timepoint: before the study and 6 months after initiation of study. Method of measurement: spirometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahboubeh Darban

Semnan University of Medical Sciences

dr.mdarban@gmail.com+98 23 3344 1022

Outcome results

None listed

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