Pulmonary Hypertension Secondary to Lung Disease and/or HypoxiaPhase 4NCT01449253
Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
A Phase 4 study testing Sildenafil and Bosentan in people with Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
- What is being tested?
- Sildenafil and Bosentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2011to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmHg (done in department of cardiology, AIIMS)
- Age more than 18 years
- Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease
- Willing to consent to participate in the trial
- WHO functional class I,II, III
Who cannot join
- WHO functional class IV
- Patient participating in any other trial
- Concomitant coronary artery disease
- Nitrate intake
- Liver dysfunction
- Pregnancy and lactation -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute Of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Sajal Ajmani, MBBS, 9873570408, sajalajmani@gmail.com
Surendra K Sharma, MD, Ph D
About this study
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.
Read the detailed description
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.
- Being tested
- Sildenafil, Bosentan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
20 mg initially and then increased to 20 mg TDS if there is no fall in BP
BosentanDrug
Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Active comparator | 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 Receives: Drug: Sildenafil |
| Sequential Therapy | Active comparator | 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. Receives: Drug: Sildenafil; Drug: Bosentan |
| Combination therapy | Active comparator | 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. Receives: Drug: Sildenafil; Drug: Bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiogram
Improvement in pulmonary artery pressures
Measured: 6 months
WHO functional classification
Improvement in WHO functional classification
Measured: 6 months
6 minute walk test
Improvement in 6 minute walk test
Measured: 6 months
Pulmonary function test
Improvement in Pulmonary function test
Measured: 6 months
Visual analog scale for dyspnea
Improvement in Visual analog scale for dyspnea
Measured: 6 months
Secondary outcomes (7)
Echocardiography measuring pulmonary artery pressure
Improvement in pulmonary artery pressures measured by Echocardiography
Measured: 3 months
WHO functional classification
Improvement in WHO functional classification
Measured: 3 months
6 minute walk test
Improvement in 6 minute walk test
Measured: 3 months
Pulmonary function test
Improvement in Pulmonary function test
Measured: 3 months
Visual analog scale for dyspnea
Improvement in Visual analog scale for dyspnea
Measured: 3 months
Biochemical markers at 3 and 6 months
Levels of biomarkers such as Trop T, pro-BNP, uric acid at 3 months and 6 months after starting the drugs
Measured: 6 months
Monitoring side effects of the drugs
adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Secondary to Lung Disease and/or HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.K.SHARMA, All India Institute of Medical Sciences
- Investigators
- Surendra K. Sharma, MD,Ph.D, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449253
- Sponsor's protocol ID
- pulmonary hypertension
- Status last verified
- Jan 2013
- First submitted
- 7 Oct 2011
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
- ClinicalTrials.gov ID
- NCT01449253
- Acronym / sponsor ID
- pulmonary hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Active comparator | Drug: SildenafilSildenafil 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 |
| Sequential Therapy | Active comparator | Drug: Sildenafil, Drug: BosentanBosentan 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. |
| Combination therapy | Active comparator | Drug: Sildenafil, Drug: BosentanBosentan 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmHg (done in department of cardiology, AIIMS)
- Age more than 18 years
- Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease
- Willing to consent to participate in the trial
- WHO functional class I,II, III
Key exclusion criteria (6 listed)
- WHO functional class IV
- Patient participating in any other trial
- Concomitant coronary artery disease
- Nitrate intake
- Liver dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil20 mg initially and then increased to 20 mg TDS if there is no fall in BP | Drug | Combination therapy, Monotherapy, Sequential Therapy |
| BosentanBosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD | Drug | Combination therapy, Sequential Therapy |
Primary outcome
Echocardiogram
Time frame: 6 months
Improvement in pulmonary artery pressures
WHO functional classification
Time frame: 6 months
Improvement in WHO functional classification
6 minute walk test
Time frame: 6 months
Improvement in 6 minute walk test
Pulmonary function test
Time frame: 6 months
Improvement in Pulmonary function test
Visual analog scale for dyspnea
Time frame: 6 months
Improvement in Visual analog scale for dyspnea
7 secondary outcomes
Echocardiography measuring pulmonary artery pressure
Time frame: 3 months
WHO functional classification
Time frame: 3 months
6 minute walk test
Time frame: 3 months
Pulmonary function test
Time frame: 3 months
Visual analog scale for dyspnea
Time frame: 3 months
Biochemical markers at 3 and 6 months
Time frame: 6 months
Monitoring side effects of the drugs
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surendra K. Sharma, MD,Ph.D principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil and Bosentan in people with Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sajal Ajmani, MBBS (919873570408, sajalajmani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiogram (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.