A clinical trial to study the lung deposition of a pressurized metered dose inhaler (pMDI)in patients with COPD and Asthma

Phase 4

Completed

• Registration Number: CTRI/2010/091/000495
• Lead Sponsor: Glenmark Pharmaceuticals Ltd.,Glenmark House,HDO-Corporate Building,Wing-A, B.D. Sawant Marg, Chakala,Off Western Express Highway,Andheri (E) Mumbai 400099.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

(i) Outpatients, men ≥ 40 years
(ii) COPD diagnosed as a forced expiratory volume in 1 second (FEV1) of no more than 65% of predicted, a ratio of FEV1 to forced vital capacity (FVC) of no more than 0.70 and who are current or former smokers (at least 10 pack
years)
(iii) Patients with stable mild to moderate persistent asthma; asthma diagnosed as improvement ≥12% reversibility in FEV1 or FVC following administration of an inhaled β2-agonist; baseline forced expiratory volume in one second 60% ≤(FEV1)≤ 90% of predicted value; Stability was ascertained if the patient remained in the same severity class (mild, moderate) and had no acute exacerbations by investigator judgment during the past 14 days
(iv) Ability to master pMDI inhalation technique in dummy experiments
(v) Written informed consent by patients
(vi) Patients willing to follow up.

Exclusion Criteria

For COPD Patients
(i) A history and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
(ii) Patients who have experienced COPD exacerbation requiring at least one of the following treatments, hospitalization and/or a course of systemic steroid within 4 weeks prior to the study start.
(iii) Patients with significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
Patients with congenital heart diseases, lung cancer, thoracic restrictive disorders or any other coexisting diseases influencing 3-yr survival.
For asthma patients
(i) Hospitalization due to asthma during the previous 3 months
(ii) Respiratory tract infection requiring treatment with antibiotics in the previous 4 weeks;
(iii) Oral or systemic corticosteroids in the previous 4weeks;

(2) Patients unable to inhale pMDI properly and with consistency
(3)Patients with known hypersensitivity to budesonide or formoterol, Technetium 99 m to compounds structurally related to the study drugs or to any other component included
(4)Heavy smokers or patients with underlying respiratory problems interfering with vital capacity or giving rise to PFT abnormality or inconsistency
(5)Patients with osteoporosis or any condition predisposing to low bone density
(6)Patients receive an investigational drug within 30 days prior to admission to the study
(7)Patients with out of normal range values in any of the following laboratory blood tests: complete blood count, blood glucose, ionogram, AST, ALT, total bilirrubin, total proteins, urea, creatinine, total cholesterol and triglycerides and urine potassium levels.
(8)Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified