Phase 2 N=38 Randomized Quadruple-blind Basic Science

A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis

Bronchiectasis

Bottom Line

View on ClinicalTrials.gov: NCT00769119 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline — 1.08; 1.01 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AZD9668 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline	1.08; 1.01	—
PRIMARY Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline	1.12; 1.04	—
PRIMARY 24-hour Sputum Weight(g)	-0.15; -5.37	—
PRIMARY Slow Vital Capacity (SVC)	0.07; -0.07	—
PRIMARY Forced Expiratory Volume in 1 Second (FEV1)	0.06; -0.04	—
PRIMARY Forced Vital Capacity (FVC)	0.03; 0.00	—
PRIMARY Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)	0.08; 0.01	—
PRIMARY Morning Peak Expiratory Flow (PEF)	4.06; -4.98	—
PRIMARY Evening Peak Expiratory Flow (PEF)	4.56; -1.15	—
PRIMARY Bronkotest Diary Card Signs and Symptoms	0; 0	—
PRIMARY St George's Respiratory Questionnaire for COPD Patients (SGRQ-C)	-7.39; -1.137	—
SECONDARY Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline	0.93; 1.00	—
SECONDARY Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline	0.70; 0.98	—
SECONDARY Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline	0.74; 0.93	—
SECONDARY Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline	0.73; 1.15	—
SECONDARY Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline	0.79; 1.07	—
SECONDARY Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline	0.91; 1.06	—
SECONDARY Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline	0.83; 0.91	—
SECONDARY Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline	0.98; 0.96	—
SECONDARY Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline	0.96; 1.05	—

Summary

The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).

Eligibility Criteria

Inclusion Criteria

Female of non child bearing potential
Clinical diagnosis of bronchiectasis
Be sputum producers, with history of chronic expectoration on most days

Exclusion Criteria

Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD
FEV1 of <30% of predicted normal

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00769119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.