Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00624702
• Collaborator: (none)
• Enrollment: 98
• Locations: 2
• Arms: 4
• Duration (Months): 7
• Patients Per Site: 49
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Indacaterol maleate; Drug: Indacaterol maleate; Drug: Indacaterol maleate; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Randomized, Single-dose, Double-blind, 4-way Cross-over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Active Comparator 1 different salt formulation of Indacaterol.	Drug: Indacaterol maleate; Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
Active Comparator: 2 Active Comparator 2 different salt formulation of Indacaterol.	Drug: Indacaterol maleate; Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
Active Comparator: 3 Active Comparator 3 different salt formulation of Indacaterol.	Drug: Indacaterol maleate; Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval
Placebo Comparator: 4	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation) [throughout the study]

2. Severity of cough: to be judged independently by both the patient and the physician [throughout the study]

3. Occurrence of cough within 1 minute post dose [throughout the study]

4. Number of coughs [throughout the study]

5. Duration of coughing [throughout the study]

Secondary Outcome Measures

1. Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation) [throughout the study]

2. Severity of cough: to be judged independently by both the patient and the physician [throughout the study]

3. Occurrence of cough within 1 minute post dose [throughout the study]

4. Number of coughs [throughout the study]

5. Duration of coughing [throughout the study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Male and female patients 18 to 65 years old (inclusive)

• Patients with mild to moderate persistent asthma

• BMI must be within the range of 18-32 kg/m2 inclusive

• Female subjects must:

1. have been sterilized at least 6 months prior to screening

2. be post-menopausal with no regular bleeding for at least a year prior to inclusion

Exclusion Criteria:

• Patients with life-threatening arrhythmias

• Patients with COPD or diabetes mellitus

• History of immunocompromise, including a positive HIV

• A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigator Site	Ottawa	Ontario	Canada
2	Novartis Investigator Site	Montreal	Quebec	Canada

Sponsors and Collaborators

• Novartis

Investigators

• Principal Investigator: Novartis, Novartis investigator site

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results for QAB149B2102 can be found on the Novartis Clinical Trial Results Website

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00624702
• Other Study ID Numbers: CQAB149B2102
• First Posted: Feb 27, 2008
• Last Update Posted: Dec 19, 2020
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)
• Additional relevant MeSH terms: Asthma; Maleic acid

Study Results

No Results Posted as of Dec 19, 2020