Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-07-31

Brief Summary

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This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.This is to find out when to start combination therapy (sildenafil plus bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.

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Detailed Description

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This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia. It involves 3 arms, one getting monotherapy with sildenafil for 6 months, 2nd getting bosentan monotherapy initially for 3 months and then combination of sildenafil and bosentan for 3 months, 3rd getting combination sildenafil and bosentan from the beginning for 6 months. The aim is to decide when is the best time to start combination therapy either from start or at the time of drug failure. Improvement will be assessed by change in functional class, pulmonary pressures measured by ECHO, pulmonary function test, six minute walk test and biochemical markers. Lack of randomized trials and Indian data is there on the subject. Also adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately.

Conditions

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Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy

Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

20 mg initially and then increased to 20 mg TDS if there is no fall in BP

Sequential Therapy

Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started be added after 3 months. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. Bosentan and sildenafil will be in combination in the last 3 months. No fixed dose combination will be used.

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

20 mg initially and then increased to 20 mg TDS if there is no fall in BP

Bosentan

Intervention Type DRUG

Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD

Combination therapy

Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. No fixed dose combination will be used.

Group Type ACTIVE_COMPARATOR

Sildenafil

Intervention Type DRUG

20 mg initially and then increased to 20 mg TDS if there is no fall in BP

Bosentan

Intervention Type DRUG

Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD

Interventions

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Sildenafil

20 mg initially and then increased to 20 mg TDS if there is no fall in BP

Intervention Type DRUG

Bosentan

Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmHg (done in department of cardiology, AIIMS)
2. Age more than 18 years
3. Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease
4. Willing to consent to participate in the trial
5. WHO functional class I,II, III

Exclusion Criteria

1. WHO functional class IV
2. Patient participating in any other trial
3. Concomitant coronary artery disease
4. Nitrate intake
5. Liver dysfunction
6. Pregnancy and lactation -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No