Two-part safety, tolerability, pharmacodynamic and –kinetic study of inhaled AZD8871 in asthmatic and COPD subjects

Study identifier:D6640C00001

ClinicalTrials.gov identifier:NCT02573155

EudraCT identifier:2015-002906-36

CTIS identifier:N/A

Study Complete

Official Title

A 2-part, randomised, placebo-controlled, safety, tolerability, pharmacokinetic and pharmacodynamic study of AZD8871 delivered by inhalation in asthmatic and chronic obstructive pulmonary disease (COPD) subjects

Medical condition

Asthma (Part 1)

Phase

Phase 1

Healthy volunteers

Study drug

Dose 1, AZD8871 50 μg (Part 1), Dose 2, AZD8871 100 μg (Part 1), Dose 3, AZD8871 300 μg (Part 1), Dose 4, AZD8871 600 µg (Part 1), Dose 5, AZD8871 1200 µg (Part 1), Dose 6, AZD8871 1800 μg (Part 1), Placebo, AZD8871 placebo (Part 1), Treatment A, AZD8871 dose A (Part 2), Treatment B, AZD8871 dose B (Part 2), Treatment C, Indacaterol 150 μg (Part 2), Treatment D, Tiotropium 18 μg (Part 2)

Sex

All

Actual Enrollment

134

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 01 Oct 2015

Primary Completion Date: 01 Aug 2016

Study Completion Date: 01 Aug 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2018 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

:Part 1
1. Subjects who are able and willing to provide written informed consent prior to conducting any study-related procedures, including withdrawal of medications
2. Adult male subjects aged 18 to 70 years (both inclusive)
3. Body mass index (BMI) from 18 to 32 kg/m2 at screening
4. Clinical diagnosis of asthma (according to the Global Initiative for Asthma [GINA] guidelines) for at least 6 months prior to screening
5. Ability to change current asthma therapy, to discontinue previous prescribed medications after signature of informed consent as per required washout periods
6. Screening FEV1 value of ≥70% of the predicted normal value
7. FEV1 reversibility of ≥12% and an absolute increase of at least 200 mL over the baseline value within 30 min after inhalation of 400 µg (4 puffs) of salbutamol via a metered dose inhaler, with spacer device
8. Subjects using intermittent salbutamol and / or subjects on a stable dose of low dose Inhaled corticosteroid (as defined by the GINA guidelines) at least 4 weeks prior to screening
9. Predose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation
10. No current smokers, no subjects with a smoking history during the last 12 months and no subjects with a total smoking history of more than 10 pack-years
11. No other relevant pulmonary disease or history of thoracic surgery
12. Subjects who are otherwise healthy as determined by medical history, physical examination, 12-lead ECG findings
13. Normal blood pressure (defined as Systolic blood pressure [SBP] between 100 and 140 mmHg for subjects ≤59 years of age and between 100 and 150 mmHg for subjects ≥60 years of age, and Diastolic blood pressure [DBP] between 40 and 90 mmHg) at screening
14. Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator.
15. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis B core (HBc) antibody (IgM), hepatitis C antibody and human immunodeficiency virus (HIV) I and II antibodies at screening
16. Subjects who are negative for drugs of abuse and alcohol tests at screening and admission
17. Subjects able to perform repeatable pulmonary function testing for FEV1 according to the American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005(9) criteria at screening
Inclusion Criteria: Part 2
1. Adult male and non-childbearing female subjects aged ≥40 years with a clinical diagnosis of stable moderate to severe COPD according to GOLD guidelines at screening
2. Females must be of non-childbearing potential, confirmed at screening by fulfilling study predefined criteria
3. Post-salbutamol FEV1 <80% and ≥30% of the predicted normal value and post-salbutamol FEV1 / forced vital capacity (FVC) <70%
4. BMI < 40 kg/m2 at screening
5. Ability to change current COPD therapy, to discontinue previous prescribed medications after signature of informed consent as per required washout periods
6. Current or ex-smokers with a smoking history of ≥10 pack years
7. No evidence of clinically significant respiratory and / or cardiovascular conditions (e.g. uncontrolled hypertension) or laboratory abnormalities
8. No other relevant pulmonary disease or history of thoracic surgery
9. Subjects who are negative for HBsAg, HBc IgM, hepatitis C antibody and HIV I and II antibodies at screening
10. Subjects who are able and willing to provide written informed consent prior to conducting any study-related procedures, including withdrawal of medications
11. Medical history must be verified by either a personal physician or medical practitioner as appropriate
12. Subjects able to perform repeatable pulmonary function testing for FEV1 according to the ATS / ERS 2005(9) criteria at screening

Exclusion Criteria

(Part 1 & 2):
1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Previous enrolment or randomisation of treatment in the present study
3. Current evidence or recent history of any clinically significant and unstable disease (other than asthma/COPD) or abnormality that could put the subject at risk or could confound the results of the study
4. Subjects with a surgical history clinically relevant for the purpose of the study
5. History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin
6. Subjects with serious adverse reaction or serious hypersensitivity to Tiotropium (for Part 2 only), Indacaterol (for Part 2 only), or the formulation excipients (eg, lactose) or other drugs in the same pharmacologic class (for Part 1 and Part 2)
7. Current diagnosis of COPD (for Part 1 only) or history of / or current diagnosis for asthma (for Part 2 only)
8. Recent history of asthma / COPD exacerbation requiring hospitalisation or need for increased maintenance treatments for asthma / COPD within 6 weeks prior to screening or prior to randomisation
9. Use of daily oxygen therapy >10 h per day (for Part 2 only)
10. Use of systemic steroids for respiratory reasons within 6 weeks prior to screening
11. Lower respiratory tract infection within 6 weeks prior to screening or prior to randomisation
12. Upper respiratory tract infection requiring antibiotics within 6 weeks prior to screening or prior to randomisation
13. Current history of tuberculosis, bronchiectasis or other non-specific pulmonary disease
14. Subject with significant cardiovascular disease that may be vulnerable to cardiovascular instability
15. QTcF (QT interval corrected, Fridericia formula QT[msec]/RR[s]) interval, >450 ms for males and >470 ms for females at screening or prior to randomisation, or history of long QT syndrome
16. PR (duration in milliseconds from the beginning of wave P to onset of ventricular depolarisation [Q or R]) interval >200 ms at screening or prior to randomisation (for Part 1 only)
Note: 4- 6 hours of ECG rhythm monitoring with telemetry will be performed on Day-1 to identify patients that may have any clinical significant abnormality prior to randomisation. If this occurs, patients should not participate in the study
17. Subjects with serum potassium concentration < 3.5mmol/l at screening
18. Subjects with a history of excessive use or abuse of alcohol within the past 2 years
19. Subjects with a history of drug abuse within the past 2 years
20. Subjects who are positive for drugs of abuse and alcohol tests at screening and prior to randomisation. Subjects consuming more than 14 (female subjects) or 21 (male subjects) units of alcohol a week
21. Donation or loss >400 ml of blood and plasma within the previous 3 months prior to screening
22. Subjects with a significant infection or known inflammatory process at screening or prior to randomisation
23. Subjects with acute gastrointestinal symptoms at the time of screening or prior to randomisation (eg, nausea, vomiting, diarrhoea, heartburn)
24. Subjects with an acute infection such as influenza at the time of screening or prior to randomisation
25. Male subjects who do not agree to follow instructions to avoid pregnancies
26. Subjects who are not able to adhere to the restrictions on prior and concomitant medications
27. Subjects who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication
28. Subjects who have used any investigational drug within 3 months prior to screening or within the equivalent time of 6 half-lives of receiving the last administration, whichever is longer
29. Subjects who have received the last dose of investigational product more than 3 months ago but who are on an extended follow-up
30. Subjects who are unlikely to co-operate with the requirements of the study, or the study center or the subjects who are unwilling or unable to follow the instructions of the principal investigator

No locations available

Arms	Assigned Interventions
Experimental: Sequence 1, Part 1 Period 1: Dose 1 Period 2: Dose 3 Period 3: Dose 5	Drug: Dose 1, AZD8871 50 μg (Part 1) 50 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 3, AZD8871 300 μg (Part 1) 300 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 5, AZD8871 1200 µg (Part 1) 1200 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
Experimental: Sequence 2, Part 1 Period 1: Placebo Period 2: Dose 3 Period 3: Dose 5	Drug: Dose 3, AZD8871 300 μg (Part 1) 300 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 5, AZD8871 1200 µg (Part 1) 1200 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Placebo, AZD8871 placebo (Part 1) AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
Experimental: Sequence 3, Part 1 Period 1: Dose 1 Period 2: Placebo Period 3: Dose 5	Drug: Dose 1, AZD8871 50 μg (Part 1) 50 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 5, AZD8871 1200 µg (Part 1) 1200 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Placebo, AZD8871 placebo (Part 1) AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
Experimental: Sequence 4, Part 1 Period 1: Dose 1 Period 2: Dose 3 Period 3: Placebo	Drug: Dose 1, AZD8871 50 μg (Part 1) 50 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 3, AZD8871 300 μg (Part 1) 300 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Placebo, AZD8871 placebo (Part 1) AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
Experimental: Sequence 5, Part 1 Period 1: Dose 2 Period 2: Dose 4 Period 3: Dose 6	Drug: Dose 2, AZD8871 100 μg (Part 1) 100 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 4, AZD8871 600 µg (Part 1) 600 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 6, AZD8871 1800 μg (Part 1) 1800 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
Experimental: Sequence 6, Part 1 Period 1: Placebo Period 2: Dose 4 Period 3: Dose 6	Drug: Dose 4, AZD8871 600 µg (Part 1) 600 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 6, AZD8871 1800 μg (Part 1) 1800 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Placebo, AZD8871 placebo (Part 1) AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
Experimental: Sequence 7, Part 1 Period 1: Dose 2 Period 2: Placebo Period 3: Dose 6	Drug: Dose 2, AZD8871 100 μg (Part 1) 100 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 6, AZD8871 1800 μg (Part 1) 1800 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Placebo, AZD8871 placebo (Part 1) AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
Experimental: Sequence 8, Part 1 Period 1: Dose 2 Period 2: Dose 4 Period 3: Placebo	Drug: Dose 2, AZD8871 100 μg (Part 1) 100 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Dose 4, AZD8871 600 µg (Part 1) 600 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Placebo, AZD8871 placebo (Part 1) AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
Experimental: Sequence 1, Part 2 Period 1: Treatment A Period 2: Treatment B Period 3: Treatment E Period 4: Treatment C Period 5: Treatment D	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 2, Part 2 Period 1: Treatment B Period 2: Treatment C Period 3: Treatment A Period 4: Treatment D Period 5: Treatment E	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 3, Part 2 Period 1: Treatment C Period 2: Treatment D Period 3: Treatment B Period 4: Treatment E Period 5: Treatment A	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 4, Part 2 Period 1: Treatment D Period 2: Treatment E Period 3: Treatment C Period 4: Treatment A Period 5: Treatment B	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 5, Part 2 Period 1: Treatment E Period 2: Treatment A Period 3: Treatment D Period 4: Treatment B Period 5: Treatment C	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 6, Part 2 Period 1: Treatment D Period 2: Treatment C Period 3: Treatment E Period 4: Treatment B Period 5: Treatment A	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 7, Part 2 Period 1: Treatment E Period 2: Treatment D Period 3: Treatment A Period 4: Treatment C Period 5: Treatment B	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 8, Part 2 Period 1: Treatment A Period 2: Treatment E Period 3: Treatment B Period 4: Treatment D Period 5: Treatment C	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 9, Part 2 Period 1: Treatment B Period 2: Treatment A Period 3: Treatment C Period 4: Treatment E Period 5: Treatment D	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
Experimental: Sequence 10, Part 2 Period 1: Treatment C Period 2: Treatment B Period 3: Treatment D Period 4: Treatment A Period 5: Treatment E	Drug: Treatment A, AZD8871 dose A (Part 2) AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®) Drug: Treatment B, AZD8871 dose B (Part 2) AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®) Drug: Treatment C, Indacaterol 150 μg (Part 2) 150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule Drug: Treatment D, Tiotropium 18 μg (Part 2) 18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Muna Albayaty

PAREXEL Early Phase Clinical Unit, London, United Kingdom