Trial Outcomes & Findings for Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients (NCT NCT00758459)

NCT ID: NCT00758459

Last Updated: 2011-08-19

Results Overview

Number of patients who had an Adverse Event

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 74 participants
• Primary outcome timeframe: all study visits
• Results posted on: 2011-08-19

Participant Flow

Participant milestones

Measure	AZD1236 AZD1236	Placebo Placebo
Overall Study STARTED	35	39
Overall Study COMPLETED	32	35
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	AZD1236 AZD1236	Placebo Placebo
Overall Study Adverse Event	3	2
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Baseline characteristics by cohort

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo	Total n=74 Participants Total of all reporting groups
Age Continuous	61.7 Year n=5 Participants	61.7 Year n=7 Participants	61.7 Year n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: all study visits

Number of patients who had an Adverse Event

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Incidence of Adverse Events	13 Participants	17 Participants

SECONDARY outcome

Timeframe: Before treatment and after 1, 2, 4 and 6 weeks of treatment

Change in FEV1 from baseline to end of treatment

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Forced Expiratory Volume in 1 Second (FEV1)	-0.006 L Full Range -0.410 • Interval -0.41 to 0.45	0.003 L Full Range -0.450 • Interval -0.45 to 0.99

SECONDARY outcome

Timeframe: Before treatment and after 1, 2, 4 and 6 weeks of treatment

Change in FVC from baseline to end of treatment

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Forced Vital Capacity (FVC)	-0.048 L Full Range -0.760 • Interval -0.76 to 0.66	-0.028 L Full Range -0.730 • Interval -0.73 to 0.94

SECONDARY outcome

Timeframe: Before treatment and after 1, 2, 4 and 6 weeks of treatment

Change in VC from baseline to end of treatment

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Vital Capacity (VC)	-0.025 L Full Range -0.840 • Interval -0.84 to 0.66	-0.043 L Full Range -1.03 • Interval -1.03 to 1.09

SECONDARY outcome

Timeframe: Before treatment and after 1, 2, 4 and 6 weeks of treatment

Change in IC from baseline to end of treatment

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Inspiratory Capacity (IC)	-0.083 L Full Range -0.730 • Interval -0.73 to 0.72	0.053 L Full Range -0.620 • Interval -0.62 to 1.55

SECONDARY outcome

Timeframe: Before treatment and after 1, 2, 4 and 6 weeks of treatment

Change in FEF from baseline to end of treatment

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Forced Expiratory Flow (FEF)25-75%	-0.073 L/s Full Range -1.45 • Interval -1.45 to 0.25	0.010 L/s Full Range -0.280 • Interval -0.28 to 1.06

SECONDARY outcome

Timeframe: Daily during run-in and treatment

Change in PEF from average during run-in to average during the last 4 w of treatment

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Peak Expiratory Flow (PEF) Morning	1.45 L/min Full Range -78.4 • Interval -78.4 to 71.5	7.47 L/min Full Range -57.0 • Interval -57.0 to 138.0

SECONDARY outcome

Timeframe: Daily during run-in and treatment

Change in PEF from average during run-in to average during the last 4 w of treatment

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Peak Expiratory Flow (PEF) Evening	7.48 L/min Full Range -70.4 • Interval -70.4 to 79.6	6.69 L/min Full Range -48.1 • Interval -48.1 to 139.0

SECONDARY outcome

Timeframe: Before treatment and after 1, 2, 4 and 6 weeks of treatment

Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total	0.373 Score on scale Full Range 0.270 • Interval 0.27 to 0.9	-0.374 Score on scale Full Range -4.80 • Interval -4.8 to 1.3

SECONDARY outcome

Timeframe: Daily during run-in and treatment

Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness	-0.173 Score on scale Full Range -1.22 • Interval -1.22 to 0.885	-0.390 Score on scale Full Range -2.15 • Interval -2.15 to 0.567

SECONDARY outcome

Timeframe: Daily during run-in and treatment

Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness	-0.073 Scores on a Scale Full Range -1.10 • Interval -1.1 to 1.28	-0.212 Scores on a Scale Full Range -1.89 • Interval -1.89 to 1.41

SECONDARY outcome

Timeframe: Daily during run-in and treatment

Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score	-0.200 Scores on a Scale Full Range -1.36 • Interval -1.36 to 1.53	-0.470 Scores on a Scale Full Range -1.73 • Interval -1.73 to 0.752

SECONDARY outcome

Timeframe: Daily during run-in and treatment

Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings	-0.128 Score on scale Full Range -1.11 • Interval -1.11 to 1.03	-0.262 Score on scale Full Range -2.00 • Interval -2.0 to 0.852

SECONDARY outcome

Timeframe: Before treatment and after 6 weeks of treatment

Change from baseline to end of treatment

Outcome measures

Measure	AZD1236 n=35 Participants AZD1236	Placebo n=39 Participants Placebo
6-minute Walk Test	14.4 m Full Range -117 • Interval -117.0 to 200.0	9.68 m Full Range -111 • Interval -111.0 to 150.0

Adverse Events

AZD1236

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	AZD1236 n=35 participants at risk AZD1236	Placebo n=39 participants at risk Placebo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal Cancer Stage Unspecified	2.9% 1/35	0.00% 0/39

Other adverse events

Measure	AZD1236 n=35 participants at risk AZD1236	Placebo n=39 participants at risk Placebo
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	8.6% 3/35	10.3% 4/39
Nervous system disorders HEADACHE	11.4% 4/35	2.6% 1/39
Infections and infestations VIRAL INFECTION	2.9% 1/35	7.7% 3/39

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60