SUMIRE (Symbicort in COPD patients)

A Phase III, 12-week, Double-blind, Randomized, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of SymbicortÂ® TurbuhalerÂ® 160/4.5 Î¼g 2 Inhalations Twice Daily (Bid) Compared to OxisÂ® TurbuhalerÂ® 4.5 Î¼g 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000153

Enrollment

1260

Registered

2010-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease (COPD) Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecified

Interventions

Intervention1: Budesonide/formoterol: inhalation, 12 weeks Control Intervention1: Formoterol: 2X4.5 microgram, inhalation, bid, 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: - A current clinical diagnosis of COPD - Documented COPD symptoms for more than 2 years - A smoking history of at least 10 pack years

Exclusion criteria

Exclusion criteria: - History and/or current clinical diagnosis of asthma - History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis

Design outcomes

Primary

Measure	Time frame
Forced Expiratory Flow in one secondTimepoint: In the mornings before intake of study drugs, every 4 weeks, at clinics	—

Secondary

Measure	Time frame
COPD exacerbationTimepoint: Daily;COPD symptomsTimepoint: Daily;SGRQTimepoint: Every 4 weeks at clinics	—

Countries

Democratic People's Republic of Korea, India, Japan, Philippines, Poland, Russian Federation, Taiwan, Ukraine, Viet Nam

Contacts

Public ContactDr Ramesh Jagannathan

AstraZeneca

PaurusMehelli.Irani@astrazeneca.com91806774800

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026