A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma. (NIMBUS)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: AZD5069

Study type: Interventional

Funder types: Industry

Identifiers

NCT01704495

2012-001869-33

D3551C00001

Details and patient eligibility

About

The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Full description

A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

Enrollment: 1,147 patients

Sex: All

Ages: 18 to 150 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner.
• Diagnosis of asthma for at least 12 months (GINA 2011)
• Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
• Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
• Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)

Exclusion criteria

• Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
• Patients with recurrent, latent, or chronic infections
• Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
• Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
• Current smoker or smoking history of more than 20 pack years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,147 participants in 4 patient groups, including a placebo group

AZD5069 5 mg

Experimental group

Description:

AZD5069 oral capsules self-administered twice daily

Treatment:

Drug: AZD5069

AZD5069 15 mg

Experimental group

Description:

AZD5069 oral capsules self-administered twice daily

Treatment:

Drug: AZD5069

AZD5069 45 mg

Experimental group

Description:

AZD5069 oral capsules self-administered twice daily

Treatment:

Drug: AZD5069

Placebo

Placebo Comparator group

Description:

Placebo oral capsules self-administered twice daily

Treatment:

Drug: Placebo