AsthmaNCT00971893
A Study To Assess The Safety And Effectiveness Of Medrol® In Acute Asthma In Indian Patients
An observational study of Asthma, run by Pfizer.
Trial summary
The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Oral Methylprednisolone Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Apr 2010
- Phase
- Observational
- 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
Study population: Patients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled
Who may be able to join
- To be eligible for enrollment in this study, patients must be prescribed oral Medrol® tablets (4mg and 16 mg) for acute asthma as per the locally approved prescribing information. The prescription of Medrol® will be separated from the decision to include the patient in the study.
- Medrol® tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol® tablet will necessarily precede and will be independent of the decision to enroll patient into the study. Only those patients who have been prescribed Medrol® tablets will be evaluated for their potential eligibility for the study
- Only those patients, who are ready and willing to sign an informed consent, will be included in the study
- Subject can be contacted through telephone
Who cannot join
- Based upon history or physical exam in the emergency department (ED) or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
- Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
About this study
Official title: A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients
The present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.
Read the detailed description
Sequential enrollment
- Conditions
- Asthma
- Being tested
- Oral Methylprednisolone Tablets
- Keywords
- Acute Exacerbation of Bronchial Asthma Acute Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Methylprednisolone TabletsDrug
Oral Methylprednisolone tablets given as per locally approved prescribing information
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone Group | Not described Receives: Drug: Oral Methylprednisolone Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse within 10 days of hospital discharge (Relapse is defined as unscheduled care at a doctor's office, a clinic, or Emergency Department (ED) for symptoms of persistent or worsening asthma after hospital discharge)
Measured: 10 days after discharge
Secondary outcomes (8)
Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint).
Measured: 20 days after discharge
Change in PEFR (Peak Expiratory Flow Rate measured in Percentage of expected) between start of therapy and first follow up visit.
Measured: 8 - 22 days after discharge
Change in FEV1 (Forced Expiratory Volume in 1 second) between start of therapy and first follow up visit.
Measured: 8 - 22 days after discharge
Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge
Measured: 10 days after discharge
Proportion of patients controlled for asthma symptoms in the last 7 days after 20 days of hospital discharge
Measured: 20 days after discharge
Change in frequency in last 24 hours of inhalational Beta 2 agonist therapy between start of therapy and first follow up visit
Measured: 8 - 22 days after discharge
Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit.
Measured: 8 - 22 days after discharge
Summary of adverse events in the study
Measured: Baseline to 20 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971893
- Sponsor's protocol ID
- B0121003
- Status last verified
- Nov 2018
- First submitted
- 3 Sep 2009
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Assess the Safety and Effectiveness of Medrol® in Acute Asthma in Indian Patients
- ClinicalTrials.gov ID
- NCT00971893
- Acronym / sponsor ID
- B0121003
- Conditions
- Asthma
- Keywords
- Acute Exacerbation of Bronchial Asthma Acute Asthma
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 4 Sep 2009 (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 present study is designed to collect data on real world experience on use of Medrol in acute asthma in Indian patients.
Detailed description
Sequential enrollment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone Group | – | Drug: Oral Methylprednisolone Tablets |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of Acute Asthma who have been prescribed oral Medrol tablets, will be enrolled
Key inclusion criteria (4 listed)
- To be eligible for enrollment in this study, patients must be prescribed oral Medrol® tablets (4mg and 16 mg) for acute asthma as per the locally approved prescribing information. The prescription of Medrol® will be separated from the decision to include the patient in the study.
- Medrol® tablets, will be prescribed to the patient by the physician according to his/her usual practice. The decision to prescribe Medrol® tablet will necessarily precede and will be independent of the decision to enroll patient into the study. Only those patients who have been prescribed Medrol® tablets will be evaluated for their potential eligibility for the study
- Only those patients, who are ready and willing to sign an informed consent, will be included in the study
- Subject can be contacted through telephone
Key exclusion criteria (2 listed)
- Based upon history or physical exam in the emergency department (ED) or Clinic, subjects with known or suspected cause of pulmonary symptoms other than asthma, such as COPD, CHF, pneumonia, pulmonary embolism, or angioedema
- Any contraindication to Medrol tablet use. Contraindications of Medrol use are systemic fungal infections and known hypersensitivity to components
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 |
|---|---|---|
| Oral Methylprednisolone TabletsOral Methylprednisolone tablets given as per locally approved prescribing information | Drug | Methylprednisolone Group |
Primary outcome
Relapse within 10 days of hospital discharge (Relapse is defined as unscheduled care at a doctor's office, a clinic, or Emergency Department (ED) for symptoms of persistent or worsening asthma after hospital discharge)
Time frame: 10 days after discharge
8 secondary outcomes
Relapse within 20 days of hospital discharge (Relapse is defined as above for Primary Endpoint).
Time frame: 20 days after discharge
Change in PEFR (Peak Expiratory Flow Rate measured in Percentage of expected) between start of therapy and first follow up visit.
Time frame: 8 - 22 days after discharge
Change in FEV1 (Forced Expiratory Volume in 1 second) between start of therapy and first follow up visit.
Time frame: 8 - 22 days after discharge
Proportion of patients controlled for asthma symptoms in the last 7 days after 10 days of hospital discharge
Time frame: 10 days after discharge
Proportion of patients controlled for asthma symptoms in the last 7 days after 20 days of hospital discharge
Time frame: 20 days after discharge
Change in frequency in last 24 hours of inhalational Beta 2 agonist therapy between start of therapy and first follow up visit
Time frame: 8 - 22 days after discharge
Physician-directed intensification of pharmacologic therapy between discharge from hospital and first follow up visit.
Time frame: 8 - 22 days after discharge
Summary of adverse events in the study
Time frame: Baseline to 20 days after discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Pfizer.
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 2 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: withdrawn, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse within 10 days of hospital discharge (Relapse is defined as unscheduled care at a doctor's office, a clinic, or Emergency Department (ED) for symptoms of persistent or worsening asthma after hospital discharge) (time frame: 10 days after discharge). 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 Nov 2018.