| Eligibility |
Inclusion criteria:
- A signed and dated written informed consent prior to study participation
- Participants 40 years of age or older at Screening (Visit 1)
- Male and female participants will be included in the study. A female participant is
eligible to participate if she is not pregnant, not breastfeeding, and at least one of
the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A
WOCBP who agrees to follow the contraceptive guidance during the treatment period and
until the safety follow-up contact after the last dose of study intervention.
- An established clinical history of COPD in accordance with the definition by the
American Thoracic Society/European Respiratory Society.
- Current or former cigarette smokers with a history of cigarette smoking of greater
than equal to (>=)10 pack-years at Screening (Visit 1) (number of pack years = [number
of cigarettes per day divided by 20] times number of years smoked [for example 20
cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]). Previous
smokers are defined as those who have stopped smoking for at least 6 months prior to
Visit 1.
- Participant with history of >=2 moderate exacerbations or one severe (hospitalized)
exacerbation in the previous 12 months, and with a score of >=10 on the COPD
Assessment Test (CAT) eligible for the study treatment in the opinion of the
investigator and documented post salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of
<0.70
- Participant must be receiving daily long-acting maintenance treatment for their COPD
for at least 3 months prior to Screening. To be eligible for the study treatment
phase, participants must be compliant with their existing COPD maintenance therapy (in
the opinion of the investigator) for the preceding two weeks prior to screening.
- A negative test for active Coronavirus Disease 2019 (COVID-19) at Visit 1. The test
should be done using a molecular (Polymerase chain reaction [PCR] or antigen test)
approved by the country regulatory authorities.
Exclusion Criteria:
- Women who are pregnant or lactating or are planning on becoming pregnant during the
study.
- Participants with a current diagnosis of asthma. (Participants with a prior history of
asthma are eligible if they have a current diagnosis of COPD).
- Documented (medical records) evidence of reversibility. Reversibility is defined as an
increase in FEV1 of >=12 percent (%) and >=200 milliliter (mL) following
administration of salbutamol. Participants defined as non-reversible will have a
post-salbutamol increase in FEV1 of <200mL or a >=200mL increase that is <12% from
pre-salbutamol baselineParticipants with alpha 1-antitrypsin deficiency as the
underlying cause of COPD.
- Participants with active tuberculosis, lung cancer, and clinically significant (in the
opinion of the investigator): bronchiectasis, sarcoidosis, lung fibrosis, pulmonary
hypertension, interstitial lung diseases or other active pulmonary diseases
- Participants with lung volume reduction surgery within the 12 months prior to
Screening
- Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least
14 days prior to Screening and at least 30 days following the last dose of
oral/systemic corticosteroids and/or antibiotics (if applicable). In addition, any
participant that experiences pneumonia and/or moderate or severe COPD exacerbation
within the preceding two weeks prior to screening will be excluded.
- Respiratory tract infection that has not resolved at least 7 days prior to Screening.
- Participants with known COVID-19 positive contacts within the past 14 days should be
excluded for at least 14 days since the exposure and the participant remains symptom
free. Participants with symptoms suggestive of active COVID-19 infection e.g. fever,
cough (new or worsened), etc. are also excluded.
- Chest x-ray (poster anterior and lateral) reveals evidence of pneumonia or a
clinically significant abnormality not believed to be due to the presence of COPD, or
another condition that would hinder the ability to detect an infiltrate on chest x-ray
(CXR) (e.g. significant cardiomegaly, pleural effusion or scarring).
- Participants with historical or current evidence of clinically significant
cardiovascular, neurological, psychiatric, renal, hepatic, immunological,
gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory,
endocrine (including uncontrolled diabetes or thyroid disease) or hematological
abnormalities that are uncontrolled.
- Abnormal and clinically significant 12-lead electrocardiogram (ECG) finding at Visit
1.
- Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liters
per minute (L/min) at screening (Oxygen use <=3L/min flow at rest is not
exclusionary.)
- Participants must not start the acute phase of a pulmonary rehabilitation program
within the 4 weeks prior to Visit 1.
- Participants who are medically unable to withhold their salbutamol for the 4-hour
period required prior to spirometry testing at each study visit.
- In the opinion of the investigator, any participant who is unable to read and/or would
not be able to complete study related materials.
- Use of the following medications within the following time intervals prior to Visit 1
or during the study:
- Participants receiving antibiotics for long term therapy are not eligible for the
study.
- No use of systemic, Oral, parenteral corticosteroids within 30 days prior to screening
(Intra-articular injections are allowed).
- No use of any other investigational drug within 30 days or 5 half-lives whichever is
longer prior to screening.
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