COPDPhase 2GLADNCT00929708

Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 2 study testing AZD3199 and formoterol in people with COPD, run by AstraZeneca at 38 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: AZD3199 and formoterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 329 participants
Where: 38 sitesin 5 countries
Study dates: Jun 2009to Mar 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

COPD
Current or exsmokers, 10 pack years

Who cannot join

Asthma
Any clinically relevant abnormal findings at screening examinations
Recent COPD exacerbation

Trial locations and contacts

38 sites in 5 countries.

Country

City, postcode or hospital

38 sites in 5 countries

Japan14 sites

Research Site
Chitose, Hokkaido
Research Site
Fukuyama, Hiroshima
Research Site
Hitachi, Ibaragi
Research Site
Kitakyushu
Research Site
Machida, Tokyo
Research Site
Moriyama, Shiga
Research Site
Naka-gun, Ibaraki
Research Site
Obihiro, Hokkaido
Research Site
Osaka, Osaka
Research Site
Ōtsu, Shiga
Research Site
Sendai, Miyagi
Research Site
Tomakomai, Hokkaido
Research Site
Toyonaka, Osaka
Research Site
Yanagawa, Fukuoka

Other trials in Japan

Canada9 sites

Research Site
Greater Sudbury, Ontario
Research Site
Mississauga, Ontario
Research Site
Moncton, New Brunswick
Research Site
Pointe-Claire, Quebec
Research Site
Saint Romuald, Quebec
Research Site
St. John's, Newfoundland and Labrador
Research Site
Toronto, Ontario
Research Site
Trois-Rivières, Quebec
Research Site
Truro, Nova Scotia

Other trials in Canada

Poland7 sites

Research Site
Bialystok
Research Site
Gorzow Wlkp
Research Site
Lodz
Research Site
Lublin
Research Site
Poznan
Research Site
Szczecin
Research Site
Tarnów

Other trials in Poland

Bulgaria5 sites

Research Site
Blagoevgrad
Research Site
Pleven
Research Site
Rousse
Research Site
Sofia
Research Site
Varna

Other trials in Bulgaria

Russia3 sites

Research Site
Moscow
Research Site
Novosibirsk
Research Site
Saint Petersburg

Other trials in Russia

About this study

Official title: A 4-week, Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group, Multi-centre Study to Assess the Efficacy and Tolerability/Safety of Inhaled AZD3199 Once Daily Compared to 9 μg Formoterol Bid and Placebo in Patients With Moderate to Severe COPD

The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

Conditions: COPD
Being tested: AZD3199, formoterol, Placebo
Keywords: COPD, Efficacy, Safety, Inhalation
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD3199Drug
Dry powder for inhalation, o.d., 4 weeks
formoterolDrug
Dry powder for inhalation, b.i.d., 4 weeks
PlaceboDrug
Dry powder for inhalation, b.i.d., 4 weeks

Study groups in NCT00929708
Study group	Role	What they receive
1	Experimental	AZD3199 low dose Receives: Drug: AZD3199
2	Experimental	AZD3199 intermediate dose Receives: Drug: AZD3199
3	Experimental	AZD3199 high dose Receives: Drug: AZD3199
4	Active comparator	Formoterol 2x4.5 microgram bid Receives: Drug: formoterol
5	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)
change from baseline
Measured: 0,5 min, 15 min, 60 min, 2 h, 4 h
FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)
change from baseline
Measured: 24h, 26h

Secondary outcomes (7)

Cmax; the Highest Plasma Concentration of AZD3199 Measured
PK is only measured for AZD3199
Measured: 0,15 min, 1, 4 and 24 hours post dose
AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose
PK is only measured for AZD3199
Measured: 0,15 min, 1, 4 and 24 hours post dose
FEV1 Post Salbutamol Inhalation
Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5
Measured: Baseline (visit 2) and 26 h after the last morning dose (visit 5).
Total Number of Reliever Medication Inhalations Per 24h
Change from run-in
Measured: During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.
Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)
Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in.
Measured: Daily, during run-in and treatment
Overall Mean CCQ (Clinical COPD Questionnaire)
Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.
Measured: Mean over week 0, mean over week 1, mean over week 2, and mean over week 4
Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)
The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)
Measured: At baseline (visit 2) and after 4 weeks of treatment (visit 5).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Mar 2010

First posted29 Jun 2009 (estimated)
Study startJun 2009
Primary completionMar 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 329 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00929708
Sponsor's protocol ID: D0570C00003
Acronym: GLAD
Status last verified: Jan 2014
First submitted: 26 Jun 2009
Last updated: 17 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kuna P, Ivanov Y, Trofimov VI, Saito T, Beckman O, Bengtsson T, Jorup C, Maltais F. Efficacy and safety of AZD3199 vs formoterol in COPD: a randomized, double-blind study. Respir Res. 2013 Jun 3;14(1):64. doi: 10.1186/1465-9921-14-64.
PubMed 23731768

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-week, Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group, Multi-centre Study to Assess the Efficacy and Tolerability/Safety of Inhaled AZD3199 Once Daily Compared to 9 μg Formoterol Bid and Placebo in Patients With Moderate to Severe COPD
ClinicalTrials.gov ID: NCT00929708
Acronym / sponsor ID: GLAD / D0570C00003
Conditions: COPD
Keywords: COPD, Efficacy, Safety, Inhalation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 329 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 29 Jun 2009 (estimated)
Results: Posted 17 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
1	Experimental	Drug: AZD3199AZD3199 low dose
2	Experimental	Drug: AZD3199AZD3199 intermediate dose
3	Experimental	Drug: AZD3199AZD3199 high dose
4	Active comparator	Drug: formoterolFormoterol 2x4.5 microgram bid
5	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

COPD
Current or exsmokers, 10 pack years

Key exclusion criteria (3 listed)

Asthma
Any clinically relevant abnormal findings at screening examinations
Recent COPD exacerbation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD3199Dry powder for inhalation, o.d., 4 weeks	Drug	1, 2, 3
formoterolDry powder for inhalation, b.i.d., 4 weeks	Drug	4
PlaceboDry powder for inhalation, b.i.d., 4 weeks	Drug	5

Primary outcome

FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)
Time frame: 0,5 min, 15 min, 60 min, 2 h, 4 h
change from baseline
FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)
Time frame: 24h, 26h
change from baseline

7 secondary outcomes

Cmax; the Highest Plasma Concentration of AZD3199 Measured
Time frame: 0,15 min, 1, 4 and 24 hours post dose
AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose
Time frame: 0,15 min, 1, 4 and 24 hours post dose
FEV1 Post Salbutamol Inhalation
Time frame: Baseline (visit 2) and 26 h after the last morning dose (visit 5).
Total Number of Reliever Medication Inhalations Per 24h
Time frame: During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.
Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)
Time frame: Daily, during run-in and treatment
Overall Mean CCQ (Clinical COPD Questionnaire)
Time frame: Mean over week 0, mean over week 1, mean over week 2, and mean over week 4
Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)
Time frame: At baseline (visit 2) and after 4 weeks of treatment (visit 5).

Results and safety

Results posted to the registry on 17 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD3199 200 Mcg od	65	61
AZD3199 400 Mcg od	69	66
AZD3199 800 Mcg od	65	62
Formoterol 9 Mcg Bid	67	61
Placebo	63	57

Primary outcome: FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)

Time frame: 0,5 min, 15 min, 60 min, 2 h, 4 h. Mean (Standard Deviation). Unit: Litre

Measure	AZD3199 200 Mcg od n = 61	AZD3199 400 Mcg od n = 66	AZD3199 800 Mcg od n = 63	Formoterol 9 Mcg Bid n = 62	Placebo n = 57
Value	0.21 (0.33)	0.17 (0.31)	0.14 (0.27)	0.16 (0.22)	0.03 (0.25)

Primary outcome: FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)

Time frame: 24h, 26h. Mean (Standard Deviation). Unit: Litre

Measure	AZD3199 200 Mcg od n = 61	AZD3199 400 Mcg od n = 66	AZD3199 800 Mcg od n = 62	Formoterol 9 Mcg Bid n = 62	Placebo n = 57
Value	0.11 (0.31)	0.12 (0.28)	0.11 (0.25)	0.03 (0.23)	0.01 (0.24)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD3199 200 Mcg od	1 of 65 (1.5%)	1 of 65 (1.5%)	Not reported
AZD3199 400 Mcg od	4 of 69 (5.8%)	8 of 69 (11.6%)	Not reported
AZD3199 800 Mcg od	0 of 65 (0%)	7 of 65 (10.8%)	Not reported
Formoterol 9 Mcg Bid	3 of 67 (4.5%)	4 of 67 (6%)	Not reported
Placebo	2 of 63 (3.2%)	3 of 63 (4.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23731768Kuna P, Ivanov Y, Trofimov VI, Saito T, Beckman O, Bengtsson T, Jorup C, Maltais F. Efficacy and safety of AZD3199 vs formoterol in COPD: a randomized, double-blind study. Respir Res. 2013 Jun 3;14(1):64. doi: 10.1186/1465-9921-14-64.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Piotr Kuna, Professor principal investigator

University Hospital, Lodz, Poland

38 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD3199 and formoterol in people with COPD, run by AstraZeneca at 38 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Japan, Canada, Poland, Bulgaria, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect) (time frame: 0,5 min, 15 min, 60 min, 2 h, 4 h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00929708, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.