Bronchial AsthmaPhase 4NCT00900874
Rapid Onset Action of Salbutamol Versus Formoterol
A Phase 4 study testing salbutamol and Formoterol in people with Bronchial Asthma, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- salbutamol and Formoterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to May 2010
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD
- Mild exacerbation will be defined as:
- children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration
- no chest indrawing
- no difficulty in speech
- clinical asthma score (or pulmonary index score-annexure 1) between 6-9
Who cannot join
- Children with life threatening asthma detected by presence of any of the following:
- severe chest indrawing
- cyanosis
- irregular respiration
- altered sensorium
- Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma
Show all 9Show fewer
- If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol)
- Child not able to perform spirometry
- Parents refusing to give consent
Trial locations and contacts
1 site in 1 country.
S.K Kabra, Dr contact
India1 site, 1 recruiting
- Recruiting
AIIMS
New Delhi, New Delhi, 110029
Jenish Rajma
About this study
Official title: Comparing Rapid Bronchodilatory Effect of Formoterol and Salbutamol in Children Between 5-15 Years With Mild to Moderate Acute Exacerbation of Asthma- A Double Blind Randomized Controlled Trial
The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute exacerbation of asthma.
Read the detailed description
It is desirable to have a single MDI that can be used as both LABA and SABA. There are few studies involving few children on use of formoterol that shows rapid bronchodilatation in children with asthma and no study that used it as rescue drug in children with acute exacerbation of asthma. The purpose of the present study is to evaluate whether the rapid bronchodilatory effect of formoterol is similar to that of salbutamol in children of 5-15 years with mild exacerbation of asthma.
Children will receive either salbutamol or formoterol by MDI. Participants will be explained about the study, spirometry and inhalation of medicine with MDI and spacer. Children will receive two puffs (100 microgram each of salbutamol) or Formoterol 2 puffs (6µg /puff) by MDI and spacer. Each child will be explained about the inhalation technique by using a MDI of placebo. After shaking the MDI it will be attached to spacer (700ml volume) and actuated. Child will be asked to take 5 tidal breaths. Another puff will be given by similar method.
- Conditions
- Bronchial Asthma
- Being tested
- salbutamol, Formoterol
- Keywords
- Formoterol, Rapid bronchodilation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamolDrug
two puffs (100 microgram each of salbutamol) by MDI and spacer
FormoterolDrug
Formoterol 2 puffs (6 µg /puff) by MDI and spacer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Salbutamol + steroid Receives: Drug: salbutamol |
| 2 | Active comparator | Formoterol + steroid Receives: Drug: Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes
Measured: 60 min
Secondary outcomes (3)
Difference in average clinical asthma score between two groups
Measured: 60 min
Adverse effects like tremors, vomiting, palpitation, etc, in two groups
Measured: 60 mins
Number of patients requiring hospitalization in two groups at end of study period in two groups
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (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 Bronchial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900874
- Sponsor's protocol ID
- AIIIMS
- Status last verified
- May 2009
- First submitted
- 12 May 2009
- Last updated
- 13 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arun JJ, Lodha R, Kabra SK. Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial. BMC Pediatr. 2012 Mar 7;12:21. doi: 10.1186/1471-2431-12-21.
PubMed 22394648
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Rapid Bronchodilatory Effect of Formoterol and Salbutamol in Children Between 5-15 Years With Mild to Moderate Acute Exacerbation of Asthma- A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00900874
- Acronym / sponsor ID
- AIIIMS
- Conditions
- Bronchial Asthma
- Keywords
- Formoterol, Rapid bronchodilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 13 May 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 hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute exacerbation of asthma.
Detailed description
It is desirable to have a single MDI that can be used as both LABA and SABA. There are few studies involving few children on use of formoterol that shows rapid bronchodilatation in children with asthma and no study that used it as rescue drug in children with acute exacerbation of asthma. The purpose of the present study is to evaluate whether the rapid bronchodilatory effect of formoterol is similar to that of salbutamol in children of 5-15 years with mild exacerbation of asthma.
Children will receive either salbutamol or formoterol by MDI. Participants will be explained about the study, spirometry and inhalation of medicine with MDI and spacer. Children will receive two puffs (100 microgram each of salbutamol) or Formoterol 2 puffs (6µg /puff) by MDI and spacer. Each child will be explained about the inhalation technique by using a MDI of placebo. After shaking the MDI it will be attached to spacer (700ml volume) and actuated. Child will be asked to take 5 tidal breaths. Another puff will be given by similar method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: salbutamolSalbutamol + steroid |
| 2 | Active comparator | Drug: FormoterolFormoterol + steroid |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD
- Mild exacerbation will be defined as:
Key exclusion criteria (9 listed)
- Children with life threatening asthma detected by presence of any of the following:
- Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma
- If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol)
- Child not able to perform spirometry
- Parents refusing to give consent
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 |
|---|---|---|
| salbutamoltwo puffs (100 microgram each of salbutamol) by MDI and spacer | Drug | 1 |
| FormoterolFormoterol 2 puffs (6 µg /puff) by MDI and spacer | Drug | 2 |
Primary outcome
Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes
Time frame: 60 min
3 secondary outcomes
Difference in average clinical asthma score between two groups
Time frame: 60 min
Adverse effects like tremors, vomiting, palpitation, etc, in two groups
Time frame: 60 mins
Number of patients requiring hospitalization in two groups at end of study period in two groups
Time frame: 60 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2009.
- Derived from this study: PubMed 22394648Arun JJ, Lodha R, Kabra SK. Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial. BMC Pediatr. 2012 Mar 7;12:21. doi: 10.1186/1471-2431-12-21.
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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.
S.K Kabra, Dr contact
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 salbutamol and Formoterol in people with Bronchial Asthma, 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 6 inclusion and 9 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 13 May 2009. 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 S.K Kabra, Dr (9868397540), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes (time frame: 60 min). 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 NCT00900874, 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 13 May 2009.