Phase
Condition
Allergies & Asthma
Asthma
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult male or female subjects aged between 18 to 65 years of age (both ages inclusive)
- Diagnosis of asthma for at least 12 months prior to screening
- Pre-bronchodilator FEV1 of more than or equal to 45 % and less than or equal to 85 %.
- Subjects should be stable on their chronic asthma treatment regimen for at least 4weeks prior to screening
- Currently non-smoking;
- More than or equal to 15 % reversibility of FEV1 within 30 min following 360 mcg ofAlbuterol/salbutamol inhalation (pMDI) at screening
- Ability to discontinue their asthma controller medication safely
- Ability to replace short-acting β agonists (SABAs) ongoing at screening withAlbuterol/salbutamol inhaler.
- Women of childbearing potential must be willing to consistently use an appropriatemethod of contraception.
- Willingness to give their written informed consent to participate in the study.
- Is willing to comply with all aspects of the protocol.
- Ability to follow training given for study related procedures and assessments in theopinion of the Investigator.
Exclusion
Exclusion Criteria:
- Patients with life-threatening asthma,
- Significant respiratory disease other than asthma
- Evidence or history of clinically significant medical, surgical or psychiatric diseaseor laboratory abnormalities.
- Known hypersensitivity to any sympathomimetic drug.
- Subjects receiving β2-blockers, anti-arrhythmics, anti-depressants, and/or monoamineoxidase inhibitors within 4 weeks prior to the screening.
- Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middleear infection within 4 weeks prior to the screening visit
- Subjects who required biologic agents for asthma systemic or oral corticosteroids (forany reason), within the past 6 months prior to screening
- Evidence or history of oral candidiasis, active tuberculosis, hypercorticism, adrenalsuppression, or eye problems.
- Female subjects who are pregnant or breast-feeding or planning to be pregnant.
- Currently enrolled in another clinical study or used any investigational product (study drug), study drug, or device within 30 days or 5 elimination half-lives,whichever is longer, preceding informed consent.
- Consumes excessive amounts of alcohol, abuses drugs, or has any condition that wouldcompromise compliance with this protocol.
Study Design
Connect with a study center
Investigational Site 9
Ahmedabad, Gujarat 411057
IndiaActive - Recruiting
Investigational Site 2
Aurangabad, Maharashtra 431002
IndiaActive - Recruiting
Investigational Site 6
Nagpur, Maharashtra 440009
IndiaActive - Recruiting
Investigational Site 10
Nashik, Maharashtra 422007
IndiaSite Not Available
Investigational Site 11
Nashik, Maharashtra 422005
IndiaSite Not Available
Investigational Site 16
Nashik, Maharashtra 422002
IndiaSite Not Available
Investigational Site 1
Pune, Maharashtra
IndiaActive - Recruiting
Investigational Site 3
Pune, Maharashtra 411047
IndiaActive - Recruiting
Investigational Site 4
Jaipur, Rajasthan 302039
IndiaActive - Recruiting
Investigational Site 13
Hyderabad, Telangana 500038
IndiaActive - Recruiting
Investigational Site 5
Hyderabad, Telangana 500038
IndiaActive - Recruiting
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