A 52-WEEK, DOUBLE-BLIND, RANDOMISED, MULTI-CENTRE, PARALLEL-GROUP,PHASE III STUDY IN PATIENTS 12 YEARS AND OLDER WITH ASTHMA, EVALUATING THE EFFICACY AND SAFETY OF SYMBICORT® (BUDESONIDE/FORMOTEROL) TURBUHALER® 160/4.5 μG ‘AS NEEDED’ COMPARED WITH TERBUTALINE TURBUHALER® 0.4 MG ‘AS NEEDED’ AND WITH PULMICORT® (BUDESONIDE) TURBUHALER® 200 μG TWICE DAILY PLUS TERBUTALINE TURBUHALER® 0.4 MG ‘AS NEEDED’

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-035-14
• Date of registration: 12/09/2014
• Prospective Registration: Yes
• Primary sponsor: ASTRAZENECA - PERU,
• Public title: A 52-WEEK, DOUBLE-BLIND, RANDOMISED, MULTI-CENTRE, PARALLEL-GROUP,PHASE III STUDY IN PATIENTS 12 YEARS AND OLDER WITH ASTHMA, EVALUATING THE EFFICACY AND SAFETY OF SYMBICORT® (BUDESONIDE/FORMOTEROL) TURBUHALER® 160/4.5 μG ‘AS NEEDED’ COMPARED WITH TERBUTALINE TURBUHALER® 0.4 MG ‘AS NEEDED’ AND WITH PULMICORT® (BUDESONIDE) TURBUHALER® 200 μG TWICE DAILY PLUS TERBUTALINE TURBUHALER® 0.4 MG ‘AS NEEDED’
• Scientific title: A 52-WEEK, DOUBLE-BLIND, RANDOMISED, MULTI-CENTRE, PARALLEL-GROUP,PHASE III STUDY IN PATIENTS 12 YEARS AND OLDER WITH ASTHMA, EVALUATING THE EFFICACY AND SAFETY OF SYMBICORT® (BUDESONIDE/FORMOTEROL) TURBUHALER® 160/4.5 μG ‘AS NEEDED’ COMPARED WITH TERBUTALINE TURBUHALER® 0.4 MG ‘AS NEEDED’ AND WITH PULMICORT® (BUDESONIDE) TURBUHALER® 200 μG TWICE DAILY PLUS TERBUTALINE TURBUHALER® 0.4 MG ‘AS NEEDED’
• Date of first enrolment: 13/10/2014
• Target sample size: 252
• Recruitment status: Recruiting
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=035-14
• Study type: Interventional
• Study design: This is a 52-week, double-blind, randomised, multi-centre, parallel-group, Phase III study; in patients 12 years and older with asthma, evaluating the efficacy and safety of; Symbicort® (budesonide/formoterol) Turbuhaler® 160/4.5 μg ‘as needed’ compared with; terbutaline Turbuhaler® 0.4 mg ‘as needed’ and with Pulmicort® (budesonide) Turbuhaler®; 200 μg twice daily plus terbutaline Turbuhaler® 0.4 mg ‘as needed’.
• Phase: III

Countries of recruitment

Argentina, Australia, Brazil, Canada, Chile, China, Mauritania, Mexico, Poland, Russian Federation, South Africa, Ukraine, United Kindgdom

Contacts

• Name: Ursula Chavez Rodriguez-Frias
• Affiliation: ASTRAZENECA PERU S.A.

• Name: Ursula Chavez Rodriguez-Frias
• Affiliation: ASTRAZENECA PERU S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the
patient’s parent/legal guardian is required
2. Outpatients of either gender aged ≥12 years at Visit 1
3. Diagnosis of asthma according to GINA criteria with a documented history of at
least 6 months prior to Visit 1
4. Patients who are in need for GINA step 2 treatment:
− uncontrolled on SABA ‘as needed’ as judged by the investigator for the last
30 days before Visit 2, or
− controlled on mono-maintenance therapy with low stable dose ICS (≤ 400
μg budesonide per day or corresponding dose of other ICS, see Appendix E
for conversion) or LTRAs as judged by the investigator for the last 30 days
prior to Visit 2
5. Based on lung function tests (see Section 5.1.2) at Visit 2, patients pre-treated
with
− a SABA only should have pre-bronchodilator FEV1 ≥ 60 % of predicted
normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN according to the
European Respiratory Society (ERS) guidelines (Quanjer et al 2012)
− low dose ICS or LTRAs medication should have pre-bronchodilator FEV1
≥80 % PN according to the ERS guidelines
6. Reversible airway obstruction according to a reversibility test (see Section
5.1.2.2) performed at Visit 2 defined as an increase in FEV1 ≥12% and 200 ml
relative to baseline, after inhalation of 1 mg Bricanyl Turbuhaler. The test can
be repeated at Visit 3 in case the patients fail at Visit 2. If patients on low dose
ICS or LTRAs fail at both occasions, they can still be included if they have a
documented historical reversibility within the last 12 months prior to Visit 3,
with an increase in FEV1 ≥12% and 200 ml relative to baseline after
administration of a rapid acting β2-agonist
For randomisation at Visit 3, patients should fulfil the following criteria:
7. Use of Bricanyl Turbuhaler ‘as needed’ due to asthma symptoms on at least
3 separate days during the last week of the run-in period
8. Ability to use Turbuhaler correctly and to complete the eDiary correctly.
Morning and evening data must be recorded for at least 8 days (any 8) of the last
10 days of the run-in period

Exclusion criteria:
Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site)
2. Previous enrolment in the present study
3. Participation in another clinical study with a non-biologic investigational product
or new formulation of a marketed non-biologic drug during the last 30 days prior
to Visit 1
4. Participation in another clinical trial with any marketed or investigational
biologic drug within 4 months or 5 half-lives whichever is longer, prior to Visit 1
5. Any asthma worsening requiring change in asthma treatment other than SABA
within 30 days prior to Visit 1
6. Use of oral, rectal or parenteral GCS within 30 days and/or depot parenteral
GCS within 12 weeks prior to Visit 1
7. Use of any β-blocking agent including eye-drops
8. Known or suspected hypersensitivity to study drugs or excipient
9. Current or previous smoker with a smoking history of ≥ 10 pack years
10. Medical history of life- threatening asthma including intubation and intensive
care unit admission
11. Any significant disease or disorder (e.g., cardiovascular, pulmonary other than
asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine,
metabolic, malignant, psychiatric, major physical impairment) which, in the
opinion of the investigator, may either put the patient at risk because of
participation in the study, or may influence the results of the study, or the
patient’s ability to participate in the study
12. Any clinically relevant abnormal findings in physical examination and/or vital
signs at Visit 2, which, in the opinion of the investigator, may put the patient at
risk if participating in the study
13. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile
women not using acceptable contraceptive measures, as judged by the
investigator
14. Planned hospitalisation during the study
15. Suspected poor capability, as judged by the investigator, of following
instructions of the study.
For randomisation at Visit 3, patients should not fulfil any of the following criteria:
16. Use of ≥ 6 Bricanyl Turbuhaler ‘as needed’ inhalations per day, for a certain
number of days depending on the actual length of run-in: for ≥ 2 days out of 14
days; for ≥ 3 days out of 15-21 days; for ≥ 4 days out of 22 or more days of runin.
17. Any asthma worsening requiring change in treatment other than SABA from
Visit 1 until randomisati


Age minimum: 12
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

J45

-J45

Intervention(s)

Target patient population
The target population includes male and female patients who are ≥12 years old and who
have a documented clinical diagnosis of asthma for at least 6 months prior to Visit 1.
Patients who are either uncontrolled on short acting β2 agonist ‘as needed’ or who are
controlled on mono-maintenance therapy with low stable dose inhaled corticosteroid or a
leukotriene receptor antagonist for the last 30 days before Visit 2 will be eligible for the
study.
The patients should have reversible airway obstruction. Patients should have used short
acting β2 agonist on at least 3 separate days during the last week of the run-in period.
Duration of treatment
This study starts with an enrolment visit (Visit 1) where informed consent is obtained and
inclusion and exclusion criteria are reviewed. At Visit 2 patients will enter a 2-4 week runin
period during which all of them will be treated with a short acting β2 agonist (Bricanyl)
‘as needed’ only. Eligible patients will be randomised at Visit 3 and enter a 52-week
double-blind treatment period. Two weeks after the completion of study treatment a
follow-up telephone contact will be performed. The total expected duration of the study for
a patient will be 56-59 weeks.
Investigational product, dosage and mode of administration
Symbicort Turbuhaler® 160/4.5 μg (budesonide 160 μg and formoterol fumarate dihydrate
4.5 μg per inhalation, powder for inhalation in a dry powder inhaler) used ‘as needed’ (to
relieve asthma symptoms) in addition to Placebo for budesonide (powder for inhalation in
a dry powder inhaler matching the Pulmicort Turbuhaler®) administ

Source(s) of Monetary Support

ASTRAZENECA PERU S.A.

Ethics review

Status: Approved
Approval date: 21/04/2014
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 26/05/2014
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 09/06/2014
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 03/11/2014
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 12/06/2015
Contact:

[e-mail]

Hospital Cayetano Heredia

97254626

[e-mail]

Status: Approved
Approval date: 06/07/2015
Contact:

[e-mail] - [e-mail]

Universidad San Martin de Porres

999098514

[e-mail] - [e-mail]

Status: Approved
Approval date: 28/01/2016
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]