Trial · NCT00769119
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis
NCT00769119, Phase 2, Completed, AstraZeneca; results first posted 2012-07-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis. Trials, record NCT00769119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00769119
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis
- NCT number
- NCT00769119
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Bronchiectasis
- Interventions
- AZD9668, Placebo
- First posted
- 2008-10-08
- Last updated
- 2012-08-20
- Results first posted
- 2012-07-25
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits |
| Primary | Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits |
| Primary | 24-hour Sputum Weight(g) | Baseline and day 28 | Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28 |
| Primary | Slow Vital Capacity (SVC) | Baseline and day 28 | Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28 |
| Primary | Forced Expiratory Volume in 1 Second (FEV1) | Baseline and day 28 | Forced Expiratory Volume in 1 Second (L) as a measure of lung function.Change from baseline to day 28 |
| Primary | Forced Vital Capacity (FVC) | Baseline and day 28 | Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28 |
| Primary | Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) | Baseline and day 28 | FEF25-75% as a measure of lung function.Change from baseline to day 28 |
| Primary | Morning Peak Expiratory Flow (PEF) | Last 7 days on treatment | Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment |
| Primary | Evening Peak Expiratory Flow (PEF) | Last 7 days on treatment | Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment |
| Primary | Bronkotest Diary Card Signs and Symptoms | Last 7 days on treatment | The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | ratio | LEAST_SQUARES_MEAN |
| PRIMARY | Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline | End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | ratio | LEAST_SQUARES_MEAN |
| PRIMARY | 24-hour Sputum Weight(g) | Baseline and day 28 | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | g | LEAST_SQUARES_MEAN |
| PRIMARY | Slow Vital Capacity (SVC) | Baseline and day 28 | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | L | LEAST_SQUARES_MEAN |
| PRIMARY | Forced Expiratory Volume in 1 Second (FEV1) | Baseline and day 28 | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | L | LEAST_SQUARES_MEAN |
| PRIMARY | Forced Vital Capacity (FVC) | Baseline and day 28 | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | L | LEAST_SQUARES_MEAN |
| PRIMARY | Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) | Baseline and day 28 | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | L/s | LEAST_SQUARES_MEAN |
| PRIMARY | Morning Peak Expiratory Flow (PEF) | Last 7 days on treatment | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | L/min | LEAST_SQUARES_MEAN |
| PRIMARY | Evening Peak Expiratory Flow (PEF) | Last 7 days on treatment | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | L/min | LEAST_SQUARES_MEAN |
| PRIMARY | Bronkotest Diary Card Signs and Symptoms | Last 7 days on treatment | The efficacy analysis set for each outcome measure includes those patients who received at least one dose of investigational product and for whom a baseline and at least one post-randomisation measurement is available for that outcome measure. Patients were analysed by to randomised treatment in accordance with the intention to treat principle. | events | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline | AZD9668 | 1.08 | 95% Confidence Interval 0.60 to 1.72 | ratio | |
| Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline | Placebo | 1.01 | 95% Confidence Interval 0.73 to 1.60 | ratio | |
| Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline | AZD9668 | 1.12 | 95% Confidence Interval 1.02 to 1.21 | ratio | |
| Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline | Placebo | 1.04 | 95% Confidence Interval 0.92 to 1.16 | ratio | |
| 24-hour Sputum Weight(g) | AZD9668 | -0.15 | Standard Error 4.376 | g | |
| 24-hour Sputum Weight(g) | Placebo | -5.37 | Standard Error 3.455 | g | |
| Slow Vital Capacity (SVC) | AZD9668 | 0.07 | Standard Error 0.045 | L | |
| Slow Vital Capacity (SVC) | Placebo | -0.07 | Standard Error 0.057 | L | |
| Forced Expiratory Volume in 1 Second (FEV1) | AZD9668 | 0.06 | Standard Error 0.021 | L | |
| Forced Expiratory Volume in 1 Second (FEV1) | Placebo | -0.04 | Standard Error 0.026 | L |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD9668 | 22 | |
| Overall Study | STARTED | Placebo | 16 | |
| Overall Study | COMPLETED | AZD9668 | 20 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | NOT COMPLETED | AZD9668 | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events78
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | AZD9668 | 0 | 22 | |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 16 | |
| other | Diarrhoea | Gastrointestinal disorders | AZD9668 | 2 | 22 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 16 | |
| other | Constipation | Gastrointestinal disorders | AZD9668 | 0 | 22 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 16 | |
| other | Abdominal Distension | Gastrointestinal disorders | AZD9668 | 0 | 22 | |
| other | Abdominal Distension | Gastrointestinal disorders | Placebo | 1 | 16 | |
| other | Abdominal Pain | Gastrointestinal disorders | AZD9668 | 0 | 22 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 16 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD9668 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AZD9668 | 13 | 22 |
| Total, other adverse events | Placebo | 15 | 16 |
| Total, serious adverse events | AZD9668 | 0 | 22 |
| Total, serious adverse events | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23433769 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AZD9668 vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00769119
GET https://conductscience.org/api/trials/v1/NCT00769119/results?page=2