AsthmaPhase 4NCT02345993
Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis
A Phase 4 study testing Extra fine Formoterol/Beclomethasone in people with Asthma and Asthmatic Crisis, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether extra fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment alone. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Asthmatic Crisis
- What is being tested?
- Extra fine Formoterol/Beclomethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2015to Aug 2015
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- previous asthma diagnosis by physician
- spirometry with quality grade A, B or C
- presenting with asthmatic crisis in emergency room
Who cannot join
- imminent respiratory arrest
- respiratory comorbidities (COPD, cystic fibrosis, interstitial lung disease, pneumothorax, bronchiectasis)
- use of systemic steroids in 3 months previous
- allergy to steroids
- Peripheral capillary oxygen saturation (SpO2) less than 88%.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Respiratory Diseases
Mexico City, Mexico City, 14080
About this study
Official title: Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis
The purpose of this study is to determine whether extra fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment alone.
Read the detailed description
Inhaled corticosteroids still the cornerstone in treatment of stable asthma, while bronchodilators and systemic steroids are in asthmatic crisis.
Asthmatic exacerbations are events occurring in the natural course of the disease, require a change in actual medication and they are associated with risks of complications producing important economic costs.
Some is known about non-genomic effects of inhaled corticosteroids, making possible, at least in theory, having a positive effect on treatment of a crisis. On the other hand, formoterol has been shown to have a rapid beginning of action (3 minutes), persisting its effect during 12 hours and it has been shown to be as effective as albuterol in the treatment of a crisis.
The development of extra-fine particles has allowed reaching more distal zones in the lungs producing more deposition of the drug, which as well decrease adverse effects are lesser doses of the drug are needed.
According to that, aims of this work is to determine whether extra-fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment in terms of pulmonary function, symptoms, inflammation markers and rates of hospitalization.
- Conditions
- Asthma, Asthmatic Crisis
- Being tested
- Extra fine Formoterol/Beclomethasone
- Keywords
- formoterol/beclomethasone in asthmatic crisis, asthmatic crisis treatment
- Medical subject headings
- Asthma, Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra fine Formoterol/BeclomethasoneDrug
Also called Innovair
standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation
+ formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40, 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Extra fine Formoterol/Beclomethasone | Active comparator | Group receiving the drug additional to standard treatment standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline, 0, 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation
+ formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40 minutes Receives: Drug: Extra fine Formoterol/Beclomethasone |
| Placebo | Placebo comparator | Group receiving placebo additional to standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation + Placebo, 3 puffs administered via aerochamber at baseline (0), 20, 40 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Function
change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal
Measured: 120 minutes
Secondary outcomes (4)
Need for hospitalization
Measured: 120 minutes
Change in perception of dyspnea
change in Borg and Transitional Dyspnea Index
Measured: 90 minutes
Biomarkers of inflammation
change in C- reactive protein, TNF-alpha, eosinophils
Measured: 120 minutes
interleukins
change in eosinophilic and non eosinophilic interleukins (IL-4, IL-5, IL-13, IL-17, IL-33)
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Respiratory Diseases, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jose Luis Miguel, National Institute of Respiratory Diseases, Mexico
- Investigators
- Jose Luis Miguel, MD, MsC, Principal investigator, Instituto Nacional de Enfermedades Respiratorias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345993
- Sponsor's protocol ID
- C40-14
- Status last verified
- Apr 2015
- First submitted
- 14 Jan 2015
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13.
PubMed 24041942Garcia-Sancho C, Fernandez-Plata R, Martinez-Briseno D, Franco-Marina F, Perez-Padilla JR. [Adult asthma in Mexico City: a population-based study]. Salud Publica Mex. 2012 Jul-Aug;54(4):425-32. doi: 10.1590/s0036-36342012000400013. Spanish.
PubMed 22832835Rodrigo GJ, Rodrigo C, Hall JB. Acute asthma in adults: a review. Chest. 2004 Mar;125(3):1081-102. doi: 10.1378/chest.125.3.1081.
PubMed 15006973Lipworth B, Manoharan A, Anderson W. Unlocking the quiet zone: the small airway asthma phenotype. Lancet Respir Med. 2014 Jun;2(6):497-506. doi: 10.1016/S2213-2600(14)70103-1.
PubMed 24899370
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis
- ClinicalTrials.gov ID
- NCT02345993
- Acronym / sponsor ID
- C40-14
- Conditions
- Asthma, Asthmatic Crisis
- Keywords
- formoterol/beclomethasone in asthmatic crisis, asthmatic crisis treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute of Respiratory Diseases, MexicoOther government
- Study start
- Jan 2015
- Primary completion
- May 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 26 Jan 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 determine whether extra fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment alone.
Detailed description
Inhaled corticosteroids still the cornerstone in treatment of stable asthma, while bronchodilators and systemic steroids are in asthmatic crisis.
Asthmatic exacerbations are events occurring in the natural course of the disease, require a change in actual medication and they are associated with risks of complications producing important economic costs.
Some is known about non-genomic effects of inhaled corticosteroids, making possible, at least in theory, having a positive effect on treatment of a crisis. On the other hand, formoterol has been shown to have a rapid beginning of action (3 minutes), persisting its effect during 12 hours and it has been shown to be as effective as albuterol in the treatment of a crisis.
The development of extra-fine particles has allowed reaching more distal zones in the lungs producing more deposition of the drug, which as well decrease adverse effects are lesser doses of the drug are needed.
According to that, aims of this work is to determine whether extra-fine formoterol/beclomethasona are more effective in the treatment of asthmatic crisis when added to conventional treatment compared with conventional treatment in terms of pulmonary function, symptoms, inflammation markers and rates of hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extra fine Formoterol/Beclomethasone | Active comparator | Drug: Extra fine Formoterol/BeclomethasoneGroup receiving the drug additional to standard treatment standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline, 0, 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation + formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40 minutes |
| Placebo | Placebo comparator | –Group receiving placebo additional to standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation + Placebo, 3 puffs administered via aerochamber at baseline (0), 20, 40 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- previous asthma diagnosis by physician
- spirometry with quality grade A, B or C
- presenting with asthmatic crisis in emergency room
Key exclusion criteria (5 listed)
- imminent respiratory arrest
- respiratory comorbidities (COPD, cystic fibrosis, interstitial lung disease, pneumothorax, bronchiectasis)
- use of systemic steroids in 3 months previous
- allergy to steroids
- Peripheral capillary oxygen saturation (SpO2) less than 88%.
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 |
|---|---|---|
| Extra fine Formoterol/BeclomethasoneAlso: Innovairstandard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation + formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40, 60 minutes | Drug | Extra fine Formoterol/Beclomethasone |
Primary outcome
Pulmonary Function
Time frame: 120 minutes
change in Forced Expiratory Volume in 1 second (FEV1) with respect to basal
4 secondary outcomes
Need for hospitalization
Time frame: 120 minutes
Change in perception of dyspnea
Time frame: 90 minutes
Biomarkers of inflammation
Time frame: 120 minutes
interleukins
Time frame: 120 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Background: PubMed 24041942Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13.
- Background: PubMed 22832835Garcia-Sancho C, Fernandez-Plata R, Martinez-Briseno D, Franco-Marina F, Perez-Padilla JR. [Adult asthma in Mexico City: a population-based study]. Salud Publica Mex. 2012 Jul-Aug;54(4):425-32. doi: 10.1590/s0036-36342012000400013. Spanish.
- Background: PubMed 15006973Rodrigo GJ, Rodrigo C, Hall JB. Acute asthma in adults: a review. Chest. 2004 Mar;125(3):1081-102. doi: 10.1378/chest.125.3.1081.
- Background: PubMed 24899370Lipworth B, Manoharan A, Anderson W. Unlocking the quiet zone: the small airway asthma phenotype. Lancet Respir Med. 2014 Jun;2(6):497-506. doi: 10.1016/S2213-2600(14)70103-1.
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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.
Jose Luis Miguel, MD, MsC principal investigator
Instituto Nacional de Enfermedades Respiratorias
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 Extra fine Formoterol/Beclomethasone in people with Asthma and Asthmatic Crisis, run by National Institute of Respiratory Diseases, Mexico at 1 site in Mexico.
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 3 inclusion and 5 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 Apr 2015. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
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?
Pulmonary Function (time frame: 120 minutes). 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 NCT02345993, which also lists 4 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 3 Apr 2015.