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AsthmaPhase 4NCT05152355

Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients

A Phase 4 study testing Budesonide 200 microgram/Puff, HFA MDI and Budesonide 100 microgram/Actuation Powder for Inhalation in people with Asthma, run by Intech Biopharm Ltd. at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to compare the efficacy and safety of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID in Chinese mild to moderate Asthma patients. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Asthma
What is being tested?
Budesonide 200 microgram/Puff, HFA MDI and Budesonide 100 microgram/Actuation Powder for Inhalation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
13 sitesChina
Study dates
22 Apr 2019to 9 May 2021
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 70 years old and diagnosed as Asthma in clinics
  • Diagnosed as Asthma according to the 2016 Asthma guidance of Chinese Thoracic Society, and without administer corticosteroids within three months, either new or old patients
  • FEV1 predicted ≧ 60%
  • Patients is willing to participate the study and signed the Informed Consent Form

Who cannot join

  • Allergy to budesonide or salbutamol
  • Infections of Respiratory tract, nasal-sinus and ear within 4 weeks before enrollment
  • Severe nasal allergy and need the treatment of corticostreoids and histamines.
  • Severe cardiovascular disease history
  • Has used leukotriene receptor antagonist (Montelukast, Pranlukast, Zafirlukast etc.) within 2 weeks before enrollment
  • Severe cognition or mental disorder and can not cooperation with the treatment
Show all 13Show fewer
  • Significant liver dysfunction, AST, ALT > 3 X normal upper limits, CR > 1.5 X normal upper limits
  • Patients with uncontrolled diabetes or fasting blood glucose > 10 mmol/L
  • Patients currently receiving beta-antagonists or beta-agonists treatment (including eye drops)
  • Patients who has contraindications to beta2-agonists
  • Patients who has participated others drug's clinical study within three months
  • Female patients who are pregnant or lactation or prepare to pregnant
  • Any conditions which the investigators considered not suitable to enrolled

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Bao Gang Hospital

    Baotou, Inner Mongolia, 014000

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Daqing Oil Field Hospital

    Daqing, Heilongjiang, 163411

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510650

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010100

  • Affiliated Hospital of Jining Medical University

    Jining, Shandon, 272000

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514031

  • QingDao Municipal Hospital

    Qingdao, Shandon, 266011

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050017

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030012

  • Tianjin First Central Hospital

    Tianjin, 300393

  • Meiheko Central Hospital

    Tonghua, Jilin

Other trials in China

About this study

Official title: Multi-center, Single Blind, Randomized, Parallel Study to Compare the Clinical Efficacy and Safety of Dusama (Budesonide) HFA MDI With Pulmicort (Budesonide) Turbuhaler in Mild to Moderate Chinese Asthma Patients

The primary objective of this study is to compare the efficacy and safety of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID in Chinese mild to moderate Asthma patients.

Read the detailed description

A total of 270 Chinese mild to moderate Asthma patients will be enrolled and 230 will be completed in this multi-center, randomized, single blind, parallel efficacy and safety comparison study of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID.

Conditions
Asthma
Being tested
Budesonide 200 microgram/Puff, HFA MDI, Budesonide 100 microgram/Actuation Powder for Inhalation
Keywords
budesonide, MDI, DPI, China, Asthma
Medical subject headings
Asthma

What participants receive

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

  • Budesonide 200 microgram/Puff, HFA MDIDrug

    Also called Duasma 200 mcg inhaler

    Participants will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs.

  • Budesonide 100 microgram/Actuation Powder for InhalationDrug

    Also called Pulmicort 100 mcg Turbuhaler

    Participants will inhaled 4 puffs of budesonide 100 mcg DPI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs.

Study groups in NCT05152355
Study groupRoleWhat they receive
Budesonide HFA MDI (Treatment A)ExperimentalParticipants assigned to Experimental arm will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks
Receives: Drug: Budesonide 200 microgram/Puff, HFA MDI
Budesonide DPI (Turbuhaler) (Treatment B)Active comparatorParticipants assigned to Active Comparator arm will inhaled 4 puffs of budesonide 100 mcg powder for inhalation bid (am 08:00 and pm 16:00) for 4 weeks
Receives: Drug: Budesonide 100 microgram/Actuation Powder for Inhalation

What is being measured

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

  1. Change from base line of FEV1

    The change from base line of forced expiratory volume in one second after 4 weeks treatment

    Measured: Week 0, 2 and 4

Secondary outcomes (14)

  1. Mean change from base line of morning and evening PEF

    The mean change from base line of morning and evening PEF (peak expiratory flow)

    Measured: Week 0 and 4

  2. Change from base line of FVC

    The changes from base line of FVC after 4 weeks treatment

    Measured: Week 0 and 4

  3. Change from base line of FEV1/FVC ratio

    The changes from base line of FEV1/FVC ratio after 4 weeks treatment

    Measured: Week 0 and 4

  4. Change from base line of FEF25%

    The changes from base line of FEF25% after 4 weeks treatment

    Measured: Week 0 and 4

  5. Change from base line of FEF50%

    The changes from base line of FEF50% after 4 weeks treatment

    Measured: Week 0 and 4

  6. Change from base line of FEF75%

    The changes from base line of FEF75% after 4 weeks treatment

    Measured: Week 0 and 4

  7. Change from base line of ACT

    The change from base line of Asthma Control Test after 4 weeks treatment

    Measured: Week 0, 2 and 4

  8. Daily PEF variability

    The Daily PEF variability (= (daily highest PEF-daily lowest PEF)X2/((daily highest PEF+daily lowest PEF) X 100% during the whole treatment period

    Measured: during week 0 to 4

  9. Weekly PEF variability

    The Weekly PEF variability (= (biweely highest PEF-biweekly lowest PEF)X2/((biweekly highest PEF+biweekly lowest PEF) X 100% during the whole treatment period

    Measured: during week 0 to 4

  10. Changes of day time and night time symptom

    The changes of day time and night time symptom during the treatment period

    Measured: during week 0 to 4

  11. Subjects number with acute exacerbation

    The total number of subjects with acute exacerbation during treatment period

    Measured: during week 0 to 4

  12. Total amount of rescue medication, Ventolin 100 mcg inhaler, used

    The total amount of doses of rescue medication, Ventolin 100 mcg inhaler, used during the treatment period

    Measured: during week 0 to 4

  13. Percentage of days without symptom

    The percentage of days without asthma symptom during the treatment period

    Measured: during week 0 to 4

  14. Percentage of days without using rescue medicine

    The percentage of days without using rescue medicine during the treatment period

    Measured: during week 0 to 4

Timeline

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

  1. First posted9 Dec 2021
  2. Study start22 Apr 2019
  3. Primary completion9 May 2021
  4. Study completion9 May 2021

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05152355
Sponsor's protocol ID
INTB011H01
Status last verified
Aug 2021
First submitted
30 Jul 2020
Last updated
9 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Budesonide 200 microgram/Puff, HFA MDI and Budesonide 100 microgram/Actuation Powder for Inhalation in people with Asthma, run by Intech Biopharm Ltd. at 13 sites in China.

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 4 inclusion and 13 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. 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?

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?

Change from base line of FEV1 (time frame: Week 0, 2 and 4). 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 NCT05152355.

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 9 Dec 2021.

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