AsthmaPhase 3NCT00510991
Non Invasive Ventilation in Acute Asthma
A Phase 3 study testing nippv in people with Asthma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation versus best medical therapy in patients with acute severe asthma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- nippv
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2006to Feb 2008
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of asthma of at least 1 year
- FEV1 < 50% of predicted (by age, height, and gender) or FEV1 < 200 L/minute
- Respiratory rate > 30 breaths/min
- All patients judged by the attending physician as having an acute attack of asthma ( Inability to speak in sentences in one breath, SaO2 < 92% ,pulsus paradoxus > 10 mm of Hg) -
Who cannot join
- Smoking history of > 10 years
- Chronic obstructive pulmonary disease
- Endotracheal intubation
- Room air saturation < 88 % or arterial PaO2 < 55 mm of Hg
- Hemodynamic instability defined as systolic BP < 90 mm Hg
- Altered state of consciousness
Show all 12Show fewer
- Congestive heart failure
- Ischemic heart disease
- Upper airway obstruction
- Facial deformity
- Pregnancy
- Pulmonary infiltrates consistent with pulmonary edema or pneumonia
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, Chandigarh, 160012
Digamber Behera, MD, 00911722756822, dbehera@indiachest.org
About this study
The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation versus best medical therapy in patients with acute severe asthma
Read the detailed description
In the past, the mainstay of treatment for patients progressing to respiratory failure from acute asthma was intubation and mechanical ventilation. Newer strategies to prevent these intubations to prevent the inherent complications are being explored in form of various pharmacological means like heliox, magnesium sulfate etc. Non pharmacological strategies among which non invasive positive pressure ventilation (NIPPV) is one of the most challenging after showing success in patients with chronic obstructive airway disease (COPD) and cardiogenic pulmonary edema.
Data on efficacy of NIPPV in the management of AA is sparse but has the potential to improve the management of acute severe asthma. Noninvasive ventilation merits further studies in patients with AA, and some consensus panels have suggested that its widespread application in patients with asthma await such trials.The role of NIPPV is not yet clear and needs further studies and keeping this in view we planned this study to study the role of NIPPV in the management of acute asthma.
- Conditions
- Asthma
- Being tested
- nippv
- Keywords
- ASTHMA
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nippvDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | NIPPV Receives: Device: nippv |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in lung function defined as an increase of at least 50% in FEV1 as compared to baseline value on admission or an increase in FEV1 to > 60% of predicted value
Measured: Time to discharge
Intensive care unit length of stay
Measured: Time to discharge
Hospital length of stay
Measured: Time to discharge
Secondary outcomes (6)
Improvement in the clinical status
Measured: Time to discharge
Disappearance of pulsus paradoxus
Measured: Time to discharge
Improvement in arterial blood gases
Measured: Time to discharge
Improvement in oxygen saturation
Measured: Time to discharge
Requirements of FiO2 , medications.
Measured: Time to discharge
Need for mechanical ventilation
Measured: Time to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startJul 2006
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- Alok Nath, MD, Principal investigator, PGIMER, Chandigarh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510991
- Sponsor's protocol ID
- 0002
- Status last verified
- Feb 2008
- First submitted
- 2 Aug 2007
- Last updated
- 3 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gupta D, Nath A, Agarwal R, Behera D. A prospective randomized controlled trial on the efficacy of noninvasive ventilation in severe acute asthma. Respir Care. 2010 May;55(5):536-43.
PubMed 20420722
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Ventilation in Acute Asthma
- ClinicalTrials.gov ID
- NCT00510991
- Acronym / sponsor ID
- 0002
- Conditions
- Asthma
- Keywords
- ASTHMA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2006
- Study completion
- Feb 2008 (estimated)
- First posted
- 3 Aug 2007 (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.
The aim of this study is to compare the efficacy of noninvasive positive pressure ventilation versus best medical therapy in patients with acute severe asthma
Detailed description
In the past, the mainstay of treatment for patients progressing to respiratory failure from acute asthma was intubation and mechanical ventilation. Newer strategies to prevent these intubations to prevent the inherent complications are being explored in form of various pharmacological means like heliox, magnesium sulfate etc. Non pharmacological strategies among which non invasive positive pressure ventilation (NIPPV) is one of the most challenging after showing success in patients with chronic obstructive airway disease (COPD) and cardiogenic pulmonary edema.
Data on efficacy of NIPPV in the management of AA is sparse but has the potential to improve the management of acute severe asthma. Noninvasive ventilation merits further studies in patients with AA, and some consensus panels have suggested that its widespread application in patients with asthma await such trials.The role of NIPPV is not yet clear and needs further studies and keeping this in view we planned this study to study the role of NIPPV in the management of acute asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: nippvNIPPV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- History of asthma of at least 1 year
- FEV1 < 50% of predicted (by age, height, and gender) or FEV1 < 200 L/minute
- Respiratory rate > 30 breaths/min
- All patients judged by the attending physician as having an acute attack of asthma ( Inability to speak in sentences in one breath, SaO2 < 92% ,pulsus paradoxus > 10 mm of Hg) -
Key exclusion criteria (12 listed)
- Smoking history of > 10 years
- Chronic obstructive pulmonary disease
- Endotracheal intubation
- Room air saturation < 88 % or arterial PaO2 < 55 mm of Hg
- Hemodynamic instability defined as systolic BP < 90 mm Hg
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 |
|---|---|---|
| nippv | Device | A |
Primary outcome
Improvement in lung function defined as an increase of at least 50% in FEV1 as compared to baseline value on admission or an increase in FEV1 to > 60% of predicted value
Time frame: Time to discharge
Intensive care unit length of stay
Time frame: Time to discharge
Hospital length of stay
Time frame: Time to discharge
6 secondary outcomes
Improvement in the clinical status
Time frame: Time to discharge
Disappearance of pulsus paradoxus
Time frame: Time to discharge
Improvement in arterial blood gases
Time frame: Time to discharge
Improvement in oxygen saturation
Time frame: Time to discharge
Requirements of FiO2 , medications.
Time frame: Time to discharge
Need for mechanical ventilation
Time frame: Time to discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2008.
- Derived from this study: PubMed 20420722Gupta D, Nath A, Agarwal R, Behera D. A prospective randomized controlled trial on the efficacy of noninvasive ventilation in severe acute asthma. Respir Care. 2010 May;55(5):536-43.
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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.
Alok Nath, MD principal investigator
PGIMER, Chandigarh, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nippv in people with Asthma, run by Post Graduate Institute of Medical Education and Research, Chandigarh 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 4 inclusion and 12 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 3 Mar 2008. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Digamber Behera, MD (00911722756822, dbehera@indiachest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in lung function defined as an increase of at least 50% in FEV1 as compared to baseline value on admission or an increase in FEV1 to > 60% of predicted value (time frame: Time to discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510991, which also lists 1 linked publication.
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 3 Mar 2008.