Moderate to Severe Persistent Bronchial AsthmaNCT01055041
Controller Medications in the Management of Bronchial Asthma
A study testing inhaled budesonide and formeterol plus oral montelukast, inhaled budesonide and formeterol plus oral doxophylline and Doubling the dose of inhaled budesonide and formeterol in people with Moderate to Severe Persistent Bronchial Asthma, run by Government Medical College, Bhavnagar at 1 site in India.
Trial summary
The purpose of this study is to know the effect of another controller medication add on to the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and compliance in patients of moderate to severe persistent bronchial asthma. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Moderate to Severe Persistent Bronchial Asthma
- What is being tested?
- inhaled budesonide and formeterol plus oral montelukast, inhaled budesonide and formeterol plus oral doxophylline and Doubling the dose of inhaled budesonide and formeterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2008to Jul 2009
- Phase
- Interventional
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged between 15 to 65 years of either sex
- had clinically diagnosed Bronchial asthma
- had poor asthma control defined by ACQ score (asthma control questionnaire) of 1.5 or greater
- FEV1 (Forced Expiratory Volume at 1 second) value of 50% or more of predicted
- improvement in FEV1 was greater than 15% after bronchodilator inhalation
Who cannot join
- major illness of system other than respiratory major respiratory illness other than asthma taken long acting anti histaminic within a preceding week of enrollment Smokers Pregnant and lactating woman history of hypersensitivity to any of above drugs
Trial locations and contacts
1 site in 1 country.
India1 site
Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India
Bhavnagar, Gujarat, 364001
About this study
Official title: A Randomized, Open Labeled Comparative Study to Assess the Efficacy and Safety of Controller Medications as Add on to Inhaled Steroid and Long Acting β2 Agonist in Treatment of Moderate to Severe Persistent Bronchial Asthma
The purpose of this study is to know the effect of another controller medication add on to the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and compliance in patients of moderate to severe persistent bronchial asthma.
- Being tested
- inhaled budesonide and formeterol plus oral montelukast, inhaled budesonide and formeterol plus oral doxophylline, Doubling the dose of inhaled budesonide and formeterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled budesonide and formeterol plus oral montelukastDrug
1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening
inhaled budesonide and formeterol plus oral doxophyllineDrug
1st two weeks -run in period, all participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet doxophylline sustained release(400 mg/day)orally in the morning
Doubling the dose of inhaled budesonide and formeterolDrug
1st two weeks -run in period, all groups participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg /puff + formeterol 6 mcg/puff) two times a day plus metered dose inhaler of budesonide (200 mcg/puff) two times a day
| Study group | Role | What they receive |
|---|---|---|
| inhaled budesonide and formeterol plus oral montelukast | Experimental | 1st two weeks -run in period .All three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening Receives: Drug: inhaled budesonide and formeterol plus oral montelukast |
| inhaled budesonide and formeterol plus oral doxophylline | Experimental | 1st two weeks -run in period, all three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks Receives: Drug: inhaled budesonide and formeterol plus oral doxophylline |
| Doubling the dose of inhaled budesonide and formeterol | Experimental | 1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg /puff + formeterol 6 mcg/puff) two times a day plus metered dose inhaler of budesonide (200 mcg/puff) two times a day Receives: Drug: Doubling the dose of inhaled budesonide and formeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was percentage of improvement in FEV1
Measured: 10 weeks
Secondary outcomes (1)
Improvement in PEFR (Peak expiratory flow rate), ACQ scores(asthma control questionnaire score), rates of adverse drug reaction and EPACs (episodes of poor asthma control)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Persistent 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Bhavnagar
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Yogesh A Patel, M.B.B.S, Principal investigator, Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, IndiaDr. Chandrabhanu R Tripathi, MD, Study chair, Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055041
- Sponsor's protocol ID
- Pharmacol no.03 /2008 Research
- Status last verified
- Jan 2010
- First submitted
- 22 Jan 2010
- Last updated
- 25 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Labeled Comparative Study to Assess the Efficacy and Safety of Controller Medications as Add on to Inhaled Steroid and Long Acting β2 Agonist in Treatment of Moderate to Severe Persistent Bronchial Asthma
- ClinicalTrials.gov ID
- NCT01055041
- Acronym / sponsor ID
- Pharmacol no.03 /2008 Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Government Medical College, BhavnagarUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Jan 2010 (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 purpose of this study is to know the effect of another controller medication add on to the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and compliance in patients of moderate to severe persistent bronchial asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inhaled budesonide and formeterol plus oral montelukast | Experimental | Drug: inhaled budesonide and formeterol plus oral montelukast1st two weeks -run in period .All three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening |
| inhaled budesonide and formeterol plus oral doxophylline | Experimental | Drug: inhaled budesonide and formeterol plus oral doxophylline1st two weeks -run in period, all three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks |
| Doubling the dose of inhaled budesonide and formeterol | Experimental | Drug: Doubling the dose of inhaled budesonide and formeterol1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg /puff + formeterol 6 mcg/puff) two times a day plus metered dose inhaler of budesonide (200 mcg/puff) two times a day |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- aged between 15 to 65 years of either sex
- had clinically diagnosed Bronchial asthma
- had poor asthma control defined by ACQ score (asthma control questionnaire) of 1.5 or greater
- FEV1 (Forced Expiratory Volume at 1 second) value of 50% or more of predicted
- improvement in FEV1 was greater than 15% after bronchodilator inhalation
Key exclusion criteria (1 listed)
- major illness of system other than respiratory major respiratory illness other than asthma taken long acting anti histaminic within a preceding week of enrollment Smokers Pregnant and lactating woman history of hypersensitivity to any of above drugs
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 |
|---|---|---|
| inhaled budesonide and formeterol plus oral montelukast1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening | Drug | inhaled budesonide and formeterol plus oral montelukast |
| inhaled budesonide and formeterol plus oral doxophylline1st two weeks -run in period, all participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet doxophylline sustained release(400 mg/day)orally in the morning | Drug | inhaled budesonide and formeterol plus oral doxophylline |
| Doubling the dose of inhaled budesonide and formeterol1st two weeks -run in period, all groups participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg /puff + formeterol 6 mcg/puff) two times a day plus metered dose inhaler of budesonide (200 mcg/puff) two times a day | Drug | Doubling the dose of inhaled budesonide and formeterol |
Primary outcome
The primary outcome was percentage of improvement in FEV1
Time frame: 10 weeks
1 secondary outcome
Improvement in PEFR (Peak expiratory flow rate), ACQ scores(asthma control questionnaire score), rates of adverse drug reaction and EPACs (episodes of poor asthma control)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2010.
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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.
Dr. Yogesh A Patel, M.B.B.S principal investigator
Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
Dr. Chandrabhanu R Tripathi, MD study chair
Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhaled budesonide and formeterol plus oral montelukast, inhaled budesonide and formeterol plus oral doxophylline and Doubling the dose of inhaled budesonide and formeterol in people with Moderate to Severe Persistent Bronchial Asthma, run by Government Medical College, Bhavnagar 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 1 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: finished, as of the sponsor's last update on 25 Jan 2010. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome was percentage of improvement in FEV1 (time frame: 10 weeks). 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 25 Jan 2010.