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AsthmaPhase 3LaennecNCT02853578

Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled

A Phase 3 study testing Busonid (budesonide 200mcg and 400mcg) in people with Asthma, run by Ache Laboratorios Farmaceuticos S.A. at 5 sites in Brazil.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

National clinical trial, phase III, multicenter, single-arm, efficacy study, 80 participants of both sexes, aged equal or more than 12 and less than 65 years. The group will use Busonid® (budesonide 200mcg and 400mcg) one application (inhalation) of 200 mcg every 12 hours (400mcg / day). Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Asthma
What is being tested?
Busonid (budesonide 200mcg and 400mcg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
5 sitesBrazil
Study dates
Dec 2019to Dec 2020
Phase
Phase 3
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 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Uncontrolled asthma diagnosis or partially controlled in according to the Guidelines of the Brazilian Society of Pneumology and Phlebology for Asthma Management - 2012;
  • Capacity of survey participants or legal guardians to understand and consent to the participation of the research participant in this clinical study, expressed by signing the informed consent form;
  • Ability of children survey participants 18 years understand and nod their participation in this clinical study, manifested by signing the informed assent form;
  • Baseline forced expiratory volume in one second in screening visit between 55% and 85% of predicted value (before bronchodilator use), including the extremes (ensuring that the lung function test has been performed properly);
  • Increase of 12% and 200 ml of forced expiratory volume in one second after the reversibility test at screening visit / initiation of treatment.

Who cannot join

  • Diagnosis of pneumonia, pneumothorax, pneumomediastinum, COPD, pulmonary tuberculosis, deficiency α1anti antitrypsin, lung mycosis (blastomycosis, histoplasmosis), bronchiectasis, pulmonary cystic fibrosis or other significant respiratory disease, according to the investigator;
  • Pneumothorax history, pulmonary tuberculosis, lung mycosis (blastomycosis, histoplasmosis) and COPD;
  • Immunosuppressive therapy;
  • Survey participants with immunosuppression of any kind;
  • Thoracic surgery history or any prior neoplastic process of the lung;
  • Significant heart disease;
Show all 23Show fewer
  • Four or more systemic corticosteroid courses in the last 12 months;
  • Participants who have needed hospitalization or care in the emergency room or emergency service (duration> 12 hours) to airway obstruction control (for exacerbation of asthma), at least once within the last three (03) months;
  • History of asthma crisis with risk of death;
  • Ventilatory support needs due to respiratory failure secondary to asthma within the past five (05) years;
  • Infection of the upper respiratory tract or lower (viral or bacterial) within the last four (04) weeks prior to study entry;
  • Any finding of clinical observation (clinical evaluation / physical) that is interpreted by the medical researcher as a risk to the research participant in the clinical study;
  • Known hypersensitivity to drug components used during the study;
  • Use of forbidden drugs in the clinical study described in Protocol;
  • Smokers and former smokers;
  • HIV infection, whether on antiretroviral treatment;
  • History of abuse of illicit drugs;
  • Disorders diagnosis of hypothalamic-pituitary-adrenal axis (hypocortisolism or hypercortisolism);
  • Presence of severe obstruction of lung airflow that may present a risk of death;
  • Women in reproductive age who do not agree to use hormonal or barrier methods of contraception; except the participants declared that they perform sexual practices or exercise them not to reproductive form;
  • Female participants in a period of pregnancy or breastfeeding;
  • Clinical trial protocols of participation in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
  • Family relationship to the second degree or bond with employees or employees of Sponsor and Research Center.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Brazil5 sites

  • Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC

    Santo André, São Paulo

  • Centro de Pesquisa do Hospital Nipo Brasileiro

    São Paulo

  • Centro de Pesquisa em Pneumologia da Santa Casa de São Paulo

    São Paulo

  • Centro Paulista de Investigação Clínica - CEPIC

    São Paulo

  • IMA Brasil - Instituto de Medicina Avançada

    São Paulo

Other trials in Brazil

About this study

Official title: National Clinical Study, Multicentric, Single Arm to Evaluate the Efficacy and Safety of Busonid® (Budesonide 200 mcg and 400 mcg) to Treat Asthma Not Controlled or Partially Controlled

National clinical trial, phase III, multicenter, single-arm, efficacy study, 80 participants of both sexes, aged equal or more than 12 and less than 65 years. The group will use Busonid® (budesonide 200mcg and 400mcg) one application (inhalation) of 200 mcg every 12 hours (400mcg / day). During follow-up visits if the participant has not shown an increase in forced expiratory volume in one second greater than 12% and greater than 0,20L or 200ml in spirometry compared with baseline visit, will increase the dose to 800 mcg / day (2x 400 mcg day).

The study aims to revalidate by the National Health Surveillance Agency (ANVISA) the registration of the drug Busonid® which there is a vast scientific literature on the pre-clinical and clinical evidence that the efficacy and safety of budesonide. Thus, outlined is a single-arm study, which is applied to the study of the group of participants the same intervention for a certain period and the participants are evaluated for response.

Read the detailed description

Busonid® is composed of budesonide and has two performances of 200mcg and 400mcg. It is a corticosteroid hormone with topical anti-inflammatory activity. The slow and continuous release of budesonide in the airways due to their esterification and their short plasma half life increases the selectivity of the corticosteroid to the airways, in patients with asthma, inhaled corticosteroids have a broad spectrum of anti-inflammatory effects, such as reducing the number of inflammatory cells in the lungs and inhibiting the synthesis and release of cytokines and other inflammatory mediators.

Conditions
Asthma
Being tested
Busonid (budesonide 200mcg and 400mcg)
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Busonid (budesonide 200mcg and 400mcg)Drug

    Also called Busonid

    cartridge containing 60 tablets of 200 mcg or 400 mcg and an inhaler;

    1 application (inhalation) of 200mcg every 12 noon (400 mcg / day). During the visits of monitoring (V1 and V2) the doctor in charge assess the need to increase the dose of PSI 400mcg for every 12 hours (800mcg / day); treatment for 12 weeks.

Study groups in NCT02853578
Study groupRoleWhat they receive
Busonid (budesonide 200mcg and 400mcg)ExperimentalIt´s a capsule with inhalatoin powder composed of budesonide 200mcg or 400mcg. The experimental drug will be dispensed in a cartridge containing 60 capsules of 200 mcg or 400 mcg and an inhaler. It should be stored at room temperature (between 15 and 30°C) and protected from moisture. Regarding the dosage, the 80 study participants will perform an inhalation 200mcg every 12 hours (400 mcg / day). During follow-up visits (V1 and V2) the attending physician will assess the need for increased PSI dose to 400 mcg every 12 hours (800mcg / day). Study participants should rinse the mouth with water and / or brush your teeth immediately after use of the drug. The duration of treatment may be 12 weeks.
Receives: Drug: Busonid (budesonide 200mcg and 400mcg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Busonid® (budesonide 200 mcg and 400 mcg) in the treatment of asthma after the initiation of treatment (FEV1)

    The absolute change in forced expiratory volume in one second [FEV1 (L)], 12 weeks after start of treatment (VF) compared to baseline (V0) was measured by spirometry test.

    Measured: 12 weeks

Secondary outcomes (7)

  1. Evaluate the FEV1 (L) during treatment compared to baseline.

    Absolute change of FEV1 (L) during treatment (weeks 4, 8 and 12) compared to baseline (week 0).

    Measured: 4, 8 and 12 weeks

  2. Evaluate the FEV1 (% of predicted) during treatment compared to baseline.

    Absolute change of FEV1 (% of predicted) during treatment (weeks 4, 8 and 12) compared to baseline (week 0).

    Measured: 4, 8 and 12 weeks

  3. Evaluate the FEV1 / FVC during treatment compared to baseline.

    Absolute change of FEV1 / FVC during treatment (weeks 4, 8 and 12) compared to baseline (week 0).

    Measured: 4, 8 and 12 weeks

  4. Evaluate the peak expiratory flow behavior measured each morning and evening throughout the treatment as compared to baseline.

    Absolute variation in peak expiratory flow, measured in the morning and evening, through the peak expiratory flow meter laptop at weeks 2, 4, 6, 8, 10 and 12 relative to baseline morning and evening, which will be measured on the day of V0. The peak expiratory flow of weeks 2, 4, 6, 8, 10 and 12 will be determined by the arithmetic mean of the last seven days prior to the week in review.

    Measured: 2, 4, 6, 8, 10 and 12 weeks

  5. Evaluate the occurrence of nighttime awakenings due to symptoms asthma during treatment.

    Nights rate with awakenings due to asthma symptoms, set at 2-week intervals (1 and 2; 3 and 4; 5 and 6; 7 and 8; 9 and 10; 11 and 12), as assessed by daily participant.

    Measured: 12 weeks

  6. Assess the need for use of rescue medication over treatment.

    Average number of rescue medication used by jets day set at 2 week intervals (1 and 2; 3 and 4; 5 and 6; 7 and 8; 9 and 10; 11 and 12) as daily participant.

    Measured: 12 weeks

  7. Assess satisfaction to treatment by the investigator and participant search / legal representative throughout the treatment.

    Satisfaction with treatment, according to investigator assessment and the research participant / legal representative, expressed by the Visual Analogue Scale.

    Measured: 4, 8 and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2016 (estimated)
  2. Study startDec 2019 (estimated)
  3. Primary completionOct 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Why it stopped: The viability of the study is being analyzed

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02853578
Sponsor's protocol ID
ACH-BSN-03(14/14)
Acronym
Laennec
Status last verified
Jul 2019
First submitted
25 Jul 2016
Last updated
8 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Busonid (budesonide 200mcg and 400mcg) in people with Asthma, run by Ache Laboratorios Farmaceuticos S.A. at 5 sites in Brazil.

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 23 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: paused, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Efficacy of Busonid® (budesonide 200 mcg and 400 mcg) in the treatment of asthma after the initiation of treatment (FEV1) (time frame: 12 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 NCT02853578.

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 8 Jul 2019.

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