To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis (BosSilSS)
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|ClinicalTrials.gov Identifier: NCT03053739|
Recruitment Status : Unknown
Verified February 2017 by DR PREKSHA DWIVEDI, Postgraduate Institute of Medical Education and Research.
Recruitment status was: Recruiting
First Posted : February 15, 2017
Last Update Posted : February 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Associated Pulmonary Arterial Hypertension||Drug: Sildenafil 20mg and Bosentan 62.5mg Drug: Sildenafil 20mg and Placebo||Phase 4|
All patients fulfilling the SSc classification criteria of American College of Rheumatology during the study period will be screened for presence of PAH. Diagnosed cases of PAH based on CD echo with PAP >35mmHg based on echocardiography will be enrolled in study.Baseline NYHA functional class and 6 min walk distance in meters will be assessed. Heamogram and LFT will be measured Patients will be assessed at two weeks for side effects/safety issues. 6MWT and NYHA functional class will be reassessed at 3 months and 6 months.2D echo will be done at 6 months to measure mPAP RandomizationAll eligible patients will be randomized in a 1:1 ratio in blocks of ten between the two arms. Randomization will be stratified based on severity of PAH. The drugs will be labelled as A and B randomly by another staff member, who will not be involved in deciding the treatment of the study subjects. The randomization sequence will be generated using computer random number generator.
Blinding will be ensured by matching placebo for ERA in one group and will labelled one treatment arm as 'A' and other treatment arm as 'B'. Allocation concealment will be ensured by means of enclosing the randomization sequence in sealed opaque envelopes. Sealed opaque envelopes will contain Code 'A' or Code 'B'.
Intervention-The study consists of two treatment arms. The study drugs mainly Bosentan and Placebo will be packed into matching tablets at the dosage 62.5 mg. One treatment arm will contain Sildenafil and Placebo while other treatment arm will contain Sildenafil and Bosentan. Treatment will be initiated as 20 mg twice a day for Sildena-fil in combination with placebo once a day in one treatment arm and with Bosentan 62.5 mg once a day in other treatment arm .Dose of Sildenafil will be increased to 20 mg thrice a day at four weeks and that of Bosentan to 62.5 mg twice a day. Placebo will be also be provided twice a day.This will be continued till end of study period.. Dose adjustments in case of adverse events will be made depending on the severity of adverse events.
Statistical analysis- Intention to treat analysis will be carried for the primary and secondary outcomes. For continuous outcomes, unpaired t-test and for dichotomous outcomes chi-squares test with Yate's correction will be used. P<0.05 will be considered significant
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Combination arm A-Sildenafil and Bosentan
Combination Arm A -Intervention- Drug
Drug: Sildenafil 20mg and Bosentan 62.5mg
Sildenafil 20 mg three times a day and bosentan 62.5mg two times a day
Placebo Comparator: Monotherapy arm-Sildenafil and Placebo
Monotherapy arm B Intervention-Drugs Tab Sildenafil 20mg- three times a day for 6 months, and Placebo tab (matched for bosentan) for 6 months
Drug: Sildenafil 20mg and Placebo
Sildenafil 20 mg three times a day and placebo (matched for bosentan)two times a day
- Change in Pulmonary artery pressures [ Time Frame: Baseline and 6 months ]Change in Pulmonary artery pressures measured by echocardiography at baseline and 6 months in patients of systemic sclerosis with PAH when treatment with Single(PDE-5inhibitors at dose of 20 mg maximum upto 60mg) versus Dual therapy(PDE-5inhibitors and ER antagonist 62.5 mg maximum upto 125mg) for 6 months
- 1.Change in 6 Minute walk distance [ Time Frame: Baseline and 6 months ]1. To compare change in 6 MWD at baseline, and 6 months when treated with single versus dual therapy.
- Time To Clinical Worsening (TTCW) [ Time Frame: Baseline and 6 months ]To compare time to clinical worsening (TTCW) in SSc patients when treated with single versus dual therapy. TTCW is defined as first occurrence of all cause deaths, PAH related hospitalisation, worsening of symptoms defined as a decrease of >15% in 6 min walk distance and worsening of NYHA functional class.
- Emergent side effects of Sildenafil and Bosentan [ Time Frame: Baseline to 6 months ]To compare the emergent side effects of sildenafil and bosentan by way of comparison of serious and nonserious side effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053739
|Contact: Preksha Dwivedi, M Dfirstname.lastname@example.org|
|Contact: Shefali Sharma, M.Demail@example.com|
|Dr Preksha Dwivedi||Recruiting|
|Chandigarh, India, 160012|
|Contact: Preksha Dwivedi, MD +91-8109492343 firstname.lastname@example.org|
|Contact: Shefali Sharma, MD +91-9417372439 Sharmashefali@hotmail.com|
|Study Chair:||Nandita Kakker, M.D||Institutional ethics committee,PGIMER Chandigarh,India|