AsthmaNCT02415179
Effect of Inhaled Mometasone/Formoterol Versus Inhaled Fluticasone/Salmeterol in Asthma Patients
A study testing Inhaled Mometasone/formoterol and Inhaled Fluticasone/Salmeterol in people with Asthma, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to investigate the effectiveness of inhaled mometasone/formoterol versus inhaled fluticasone/salmeterol on peripheral airway function in treatment of asthma. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Inhaled Mometasone/formoterol and Inhaled Fluticasone/Salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- May 2015to Feb 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed asthma according to Global Initiative for Asthma (GINA) guideline 2014 without previous treatment of inhaled corticosteroid and long acting beta agonists
- Patients with asthma symptoms of most days or wake up due to asthma one time per week or more
- Patients with the presence of any risk factors of asthma according to Global Initiative for Asthma (GINA) guideline 2014
- Patients with severe uncontrolled asthma
- Patients with previous asthma exacerbation
- Patients give consent form
Who cannot join
- Patients with contra-indication for performing spirometry according to American Thoracic Society (ATS) and European Respiratory Society (ERS) statement of standardization for spirometry
- Patients refuse to participate study -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inhaled Mometasone/Formoterol Versus Inhaled Fluticasone/Salmeterol on Peripheral Airway Function in Asthma Patients
The purpose of this study is to investigate the effectiveness of inhaled mometasone/formoterol versus inhaled fluticasone/salmeterol on peripheral airway function in treatment of asthma.
Read the detailed description
Peripheral airway dysfunction is associated with poor asthma outcome including asthma exacerbation and more symptoms. The peripheral or small airway is anatomically defined by airways with 2 mm diameter or less. Several techniques have been used for evaluating peripheral airways such as spirometry, body plethysmography, impulse oscillometry and imaging studies. Since inhaled corticosteroid is corner stone for treatment of asthma, the addition of long acting beta agonist is indicated in severe asthma with poorly controlled disease despite of high dose inhaled corticosteroid.
The inhaled corticosteroid and long acting beta agonists are available for treating asthma. There were different results in comparison studies of different inhaled corticosteroid and long acting beta agonist. These differences are related to type of inhaled formulation, potency of inhaled corticosteroid or dose and outcome measurements. The previous short term studies shown that inhaled budesonide/formoterol is superior to inhaled fluticasone/salmeterol combination for reducing of peripheral airway resistance measured by impulse oscillometry. However, the active drug was delivered by using dry powder inhaler. There is no direct comparison between inhaled mometasone/formoterol and inhaled fluticasone/salmeterol administered using metered dose inhalers. For these reasons, we conduct the open label study comparing the effect of two inhaled corticosteroid and long acting beta agonist in newly diagnosed asthma who are eligible for being treated with such combination therapies.
Eligible patients who have clinically diagnosed asthma requiring treatment with combined inhaled corticosteroid and long acting beta agonist according to Global Initiative for Asthma (GINA) guideline. The patients will be randomized to receive either inhaled mometasone/formoterol (100/5 microgram) 2 puffs twice daily or inhaled fluticasone/salmeterol (125/25 microgram) 2 puffs twice daily administered using metered dose inhalers.
The primary outcome is peripheral airway function measured by airway resistance at 5 and 20 Hz frequency from impulse oscillometry. The secondary outcome are peak expiratory flow rate, forced expiratory flow at 1 second, forced vital capacity, forced expiratory flow at 25-75% of vital capacity (FEF25-75%) measured by spirometry, residual volume per total lung capacity ratio measured by body plethysmography ,asthma control test score and asthma control questionaire-7 version. All outcome are measured at baseline and 6-week post treatments in both arms.
- Conditions
- Asthma
- Being tested
- Inhaled Mometasone/formoterol, Inhaled Fluticasone/Salmeterol
- Keywords
- Newly diagnosed asthma, peripheral airway function
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Mometasone/formoterolDrug
Inhaled Mometasone/formoterol (100/5 microgram) 2 puffs twice daily via metered dose inhaler for 6 weeks
Inhaled Fluticasone/SalmeterolDrug
Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Mometasone/formoterol | Experimental | Inhaled Mometasone/Formoterol (100/5 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks Receives: Drug: Inhaled Mometasone/formoterol |
| Inhaled Fluticasone/Salmeterol | Active comparator | Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks Receives: Drug: Inhaled Fluticasone/Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral airway function measured by impulse oscillometry
The measuring of airway resistance at 5 and 20 Hz
Measured: 6 weeks
Secondary outcomes (6)
Peak expiratory flow rate
Peak expiratory flow rate
Measured: 6 weeks
Forced expiratory volume at 1 second
Forced expiratory volume at 1 second
Measured: 6 weeks
Forced vital capacity
Forced vital capacity
Measured: 6 weeks
Forced expiratory flow rate at 25-75% of vital capacity
Forced expiratory flow rate at 25-75% of vital capacity
Measured: 6 weeks
Asthma control test score
Asthma control test score
Measured: 6 weeks
Asthma control questionnaire-7 version
Asthma control questionnaire-7 version
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tananchai Petnak, M.D., Principal investigator, Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol UniversityTheerasuk Kawamatawong, M.D., Principal investigator, Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol UniversityPrapaporn Pornsuriyasak, M.D., Principal investigator, Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol UniversityViboon Boonsarngsuk, M.D., Principal investigator, Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol UniversityNaparat Amornputtisathaporn, M.D., Principal investigator, Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415179
- Sponsor's protocol ID
- ZS-2015
- Status last verified
- Apr 2016
- First submitted
- 29 Jan 2015
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kraft M, Pak J, Martin RJ, Kaminsky D, Irvin CG. Distal lung dysfunction at night in nocturnal asthma. Am J Respir Crit Care Med. 2001 Jun;163(7):1551-6. doi: 10.1164/ajrccm.163.7.2008013.
PubMed 11401872Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002 Feb;109(2 Suppl):S447-60. doi: 10.1067/mai.2002.121409.
PubMed 11842317Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.
PubMed 16192448Meltzer EO, Kuna P, Nolte H, Nayak AS, Laforce C; P04073 Study Investigators. Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function. Eur Respir J. 2012 Feb;39(2):279-89. doi: 10.1183/09031936.00020310. Epub 2011 Aug 4.
PubMed 21828036Kirsten AM, Watz H, Brindicci C, Piccinno A, Magnussen H. Effects of beclomethason/formoterol and budesonide/formoterol fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma--an exploratory study. Pulm Pharmacol Ther. 2015 Apr;31:79-84. doi: 10.1016/j.pupt.2014.08.007. Epub 2014 Sep 4.
PubMed 25194884Bernstein DI, Hebert J, Cheema A, Murphy KR, Cherrez-Ojeda I, Matiz-Bueno CE, Kuo WL, Nolte H. Efficacy and onset of action of mometasone furoate/formoterol and fluticasone propionate/salmeterol combination treatment in subjects with persistent asthma. Allergy Asthma Clin Immunol. 2011 Dec 7;7(1):21. doi: 10.1186/1710-1492-7-21.
PubMed 22152089Hozawa S, Terada M, Hozawa M. Comparison of budesonide/formoterol Turbuhaler with fluticasone/salmeterol Diskus for treatment effects on small airway impairment and airway inflammation in patients with asthma. Pulm Pharmacol Ther. 2011 Oct;24(5):571-6. doi: 10.1016/j.pupt.2011.05.004. Epub 2011 May 23.
PubMed 21624490
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhaled Mometasone/Formoterol Versus Inhaled Fluticasone/Salmeterol on Peripheral Airway Function in Asthma Patients
- ClinicalTrials.gov ID
- NCT02415179
- Acronym / sponsor ID
- ZS-2015
- Conditions
- Asthma
- Keywords
- Newly diagnosed asthma, peripheral airway function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Apr 2015 (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 investigate the effectiveness of inhaled mometasone/formoterol versus inhaled fluticasone/salmeterol on peripheral airway function in treatment of asthma.
Detailed description
Peripheral airway dysfunction is associated with poor asthma outcome including asthma exacerbation and more symptoms. The peripheral or small airway is anatomically defined by airways with 2 mm diameter or less. Several techniques have been used for evaluating peripheral airways such as spirometry, body plethysmography, impulse oscillometry and imaging studies. Since inhaled corticosteroid is corner stone for treatment of asthma, the addition of long acting beta agonist is indicated in severe asthma with poorly controlled disease despite of high dose inhaled corticosteroid.
The inhaled corticosteroid and long acting beta agonists are available for treating asthma. There were different results in comparison studies of different inhaled corticosteroid and long acting beta agonist. These differences are related to type of inhaled formulation, potency of inhaled corticosteroid or dose and outcome measurements. The previous short term studies shown that inhaled budesonide/formoterol is superior to inhaled fluticasone/salmeterol combination for reducing of peripheral airway resistance measured by impulse oscillometry. However, the active drug was delivered by using dry powder inhaler. There is no direct comparison between inhaled mometasone/formoterol and inhaled fluticasone/salmeterol administered using metered dose inhalers. For these reasons, we conduct the open label study comparing the effect of two inhaled corticosteroid and long acting beta agonist in newly diagnosed asthma who are eligible for being treated with such combination therapies.
Eligible patients who have clinically diagnosed asthma requiring treatment with combined inhaled corticosteroid and long acting beta agonist according to Global Initiative for Asthma (GINA) guideline. The patients will be randomized to receive either inhaled mometasone/formoterol (100/5 microgram) 2 puffs twice daily or inhaled fluticasone/salmeterol (125/25 microgram) 2 puffs twice daily administered using metered dose inhalers.
The primary outcome is peripheral airway function measured by airway resistance at 5 and 20 Hz frequency from impulse oscillometry. The secondary outcome are peak expiratory flow rate, forced expiratory flow at 1 second, forced vital capacity, forced expiratory flow at 25-75% of vital capacity (FEF25-75%) measured by spirometry, residual volume per total lung capacity ratio measured by body plethysmography ,asthma control test score and asthma control questionaire-7 version. All outcome are measured at baseline and 6-week post treatments in both arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Mometasone/formoterol | Experimental | Drug: Inhaled Mometasone/formoterolInhaled Mometasone/Formoterol (100/5 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks |
| Inhaled Fluticasone/Salmeterol | Active comparator | Drug: Inhaled Fluticasone/SalmeterolInhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed asthma according to Global Initiative for Asthma (GINA) guideline 2014 without previous treatment of inhaled corticosteroid and long acting beta agonists
- Patients with asthma symptoms of most days or wake up due to asthma one time per week or more
- Patients with the presence of any risk factors of asthma according to Global Initiative for Asthma (GINA) guideline 2014
- Patients with severe uncontrolled asthma
- Patients with previous asthma exacerbation
Key exclusion criteria (2 listed)
- Patients with contra-indication for performing spirometry according to American Thoracic Society (ATS) and European Respiratory Society (ERS) statement of standardization for spirometry
- Patients refuse to participate study -
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 Mometasone/formoterolInhaled Mometasone/formoterol (100/5 microgram) 2 puffs twice daily via metered dose inhaler for 6 weeks | Drug | Inhaled Mometasone/formoterol |
| Inhaled Fluticasone/SalmeterolInhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks | Drug | Inhaled Fluticasone/Salmeterol |
Primary outcome
Peripheral airway function measured by impulse oscillometry
Time frame: 6 weeks
The measuring of airway resistance at 5 and 20 Hz
6 secondary outcomes
Peak expiratory flow rate
Time frame: 6 weeks
Forced expiratory volume at 1 second
Time frame: 6 weeks
Forced vital capacity
Time frame: 6 weeks
Forced expiratory flow rate at 25-75% of vital capacity
Time frame: 6 weeks
Asthma control test score
Time frame: 6 weeks
Asthma control questionnaire-7 version
Time frame: 6 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 26 Apr 2016.
- Background: PubMed 11401872Kraft M, Pak J, Martin RJ, Kaminsky D, Irvin CG. Distal lung dysfunction at night in nocturnal asthma. Am J Respir Crit Care Med. 2001 Jun;163(7):1551-6. doi: 10.1164/ajrccm.163.7.2008013.
- Background: PubMed 11842317Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002 Feb;109(2 Suppl):S447-60. doi: 10.1067/mai.2002.121409.
- Background: PubMed 16192448Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.
- Background: PubMed 21828036Meltzer EO, Kuna P, Nolte H, Nayak AS, Laforce C; P04073 Study Investigators. Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function. Eur Respir J. 2012 Feb;39(2):279-89. doi: 10.1183/09031936.00020310. Epub 2011 Aug 4.
- Background: PubMed 25194884Kirsten AM, Watz H, Brindicci C, Piccinno A, Magnussen H. Effects of beclomethason/formoterol and budesonide/formoterol fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma--an exploratory study. Pulm Pharmacol Ther. 2015 Apr;31:79-84. doi: 10.1016/j.pupt.2014.08.007. Epub 2014 Sep 4.
- Background: PubMed 22152089Bernstein DI, Hebert J, Cheema A, Murphy KR, Cherrez-Ojeda I, Matiz-Bueno CE, Kuo WL, Nolte H. Efficacy and onset of action of mometasone furoate/formoterol and fluticasone propionate/salmeterol combination treatment in subjects with persistent asthma. Allergy Asthma Clin Immunol. 2011 Dec 7;7(1):21. doi: 10.1186/1710-1492-7-21.
- Background: PubMed 21624490Hozawa S, Terada M, Hozawa M. Comparison of budesonide/formoterol Turbuhaler with fluticasone/salmeterol Diskus for treatment effects on small airway impairment and airway inflammation in patients with asthma. Pulm Pharmacol Ther. 2011 Oct;24(5):571-6. doi: 10.1016/j.pupt.2011.05.004. Epub 2011 May 23.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Tananchai Petnak, M.D. principal investigator
Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University
Theerasuk Kawamatawong, M.D. principal investigator
Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University
Prapaporn Pornsuriyasak, M.D. principal investigator
Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University
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 Mometasone/formoterol and Inhaled Fluticasone/Salmeterol in people with Asthma, run by Mahidol University at 1 site in Thailand.
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 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: finished, as of the sponsor's last update on 26 Apr 2016. 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 Thailand. 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?
Peripheral airway function measured by impulse oscillometry (time frame: 6 weeks). 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 NCT02415179, which also lists 7 linked publications.
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 26 Apr 2016.